128 results on '"Ply Chichareon"'
Search Results
2. Time in target range of systolic blood pressure and clinical outcomes in atrial fibrillation patients: results of the COOL-AF registry
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Rungroj Krittayaphong, Ply Chichareon, Chulalak Komoltri, Ahthit Yindeengam, and Gregory Y. H. Lip
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Medicine ,Science - Abstract
Abstract We aimed to investigate the relationship between time in target range of systolic blood pressure (SBP-TTr) and clinical outcomes in patients with atrial fibrillation (AF). We analyzed the results from multicenter AF registry in Thailand. Blood pressure was recorded at baseline and at every 6 monthly follow-up visit. SBP-TTr were calculated using the Rosendaal method, based on a target SBP 120–140 mmHg. The outcomes were death, ischemic stroke/systemic embolism (SSE), major bleeding, and heart failure. A total of 3355 patients were studied (mean age 67.8 years; 41.9% female). Average follow-up time was 32.1 ± 8.3 months. SBP-TTr was classified into 3 groups according to the tertiles. The incidence rates of all-cause death, SSE, major bleeding, and heart failure were 3.90 (3.51–4.34), 1.52 (1.27–1.80), 2.2 (1.90–2.53), and 2.83 (2.49–3.21) per 100 person-years, respectively. Patients in the 3rd tertile of SBP-TTr had lower rates of death, major bleeding and heart failure with adjusted hazard ratios 0.62 (0.48–0.80), p
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- 2024
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3. Net clinical benefit of oral anticoagulants in Asian patients with atrial fibrillation based on a CHA2DS2-VASc score
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Komsing Methavigul, Ply Chichareon, Ahthit Yindeengam, and Rungroj Krittayaphong
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Net clinical benefit ,Anticoagulant ,Dual antithrombotic ,Atrial fibrillation ,CHA2DS2-VASc ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background This study was conducted to assess the net clinical benefit (NCB) for oral anticoagulant (OAC) in atrial fibrillation (AF) patients according to the CHA2DS2-VASc score. Methods Patients with AF were prospectively recruited in the COOL AF Thailand registry from 2014 to 2017. The incidence rate of thromboembolic (TE) events and major bleeding (MB) was calculated. Cox proportional hazards model was used to compare the TE and MB rate in patients with and without OACs in CHA2DS2-VASc score of 0–1 and ≥ 2, respectively. The survival analysis was performed based on CHA2DS2-VASc score. The NCB of OACs was defined as the TE rate prevented minus the MB rate increased multiplied by a weighting factor. Results A total of 3,402 AF patients were recruited. An average age of patients was 67.38 ± 11.27 years. Compared to non-anticoagulated patients, the Kaplan Meier curve showed anticoagulated patients with CHA2DS2-VASc score of 2 or more had the lower thromboembolic events with statistical significance (p = 0.043) and the higher MB events with statistical significance (p = 0.018). In overall AF patients, there were positive NCB in warfarin patients with CHA2DS2-VASc score of 3 or more while there were positive NCB in DOACs patients regardless of CHA2DS2-VASc score. Females with CHA2DS2-VASc score of 3 or more had a positive NCB regardless of OACs type. Good anticoagulation control (TTR ≥65%) improved an NCB in males with CHA2DS2-VASc score of 3 or more. Conclusions AF patients with CHA2DS2-VASc score of 3 or more regardless warfarin or DOACs had a positive NCB. The NCB of OACs was more positive for DOACs compared to warfarin and for females compared to males.
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- 2023
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4. Association of myosteatosis with treatment response and survival in patients with hepatocellular carcinoma undergoing chemoembolization: a retrospective cohort study
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Kittipitch Bannangkoon, Keerati Hongsakul, Teeravut Tubtawee, Natee Ina, and Ply Chichareon
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Medicine ,Science - Abstract
Abstract Patients with hepatocellular carcinoma (HCC) have poor prognosis and have frequent treatment-related toxicities resulting in cancer-associated cachexia. This study aimed to determine the association of myosteatosis and sarcopenia on mortality in patients with HCC treated with transarterial chemoembolization (TACE). Six hundred and eleven patients diagnosed with HCC and underwent TACE at a tertiary care center between 2008 and 2019 were included. Body composition was assessed using axial CT slices at level L3 to calculate the skeletal muscle density for myosteatosis and skeletal muscle index for sarcopenia. The primary outcome was overall survival while the secondary outcome was TACE response. Patients with myosteatosis had a poorer TACE response than patients without myosteatosis (56.12% vs. 68.72%, adjusted odds ratio [OR] 0.49, 95% confidence interval [CI] 0.34–0.72). The rate of TACE response in patients with sarcopenia was not different from those without sarcopenia (60.91% vs. 65.22%, adjusted OR 0.79, 95% CI 0.55–1.13). Patients with myosteatosis had shorter overall survival than without myosteatosis (15.9 vs. 27.1 months, P
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- 2023
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5. Diagnostic Performance of a Mnemonic for Warning Symptoms in Predicting Acute Coronary Syndrome Diagnosis: A Retrospective Cross-Sectional Study
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Attakowit Sattayaraksa, Thareerat Ananchaisarp, Polathep Vichitkunakorn, Ply Chichareon, and Siriwimon Tantarattanapong
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acronym ,acute coronary syndrome ,diagnostic performance ,mnemonic ,warning symptoms ,Public aspects of medicine ,RA1-1270 - Abstract
Objectives: We aimed to create a mnemonic for acute coronary syndrome (ACS) warning symptoms and determine its diagnostic performance.Methods: This retrospective cross-sectional study included patients visiting the emergency room with symptoms of suspected ACS during 2020–2021. The mnemonic was created using symptoms with an odds ratio (OR) for predicting ACS >1.0. The mnemonic with the highest OR and sensitivity was identified. Sensitivity analysis was performed to test the diagnostic performance of the mnemonic by patient subgroups commonly exhibiting atypical symptoms.Results: ACS prevalence was 12.2% (415/3,400 patients). The mnemonic, “RUSH ChesT” [if you experience referred pain (R), unexplained sweating (U), shortness of breath (S), or heart fluttering (H) together with chest pain (C), visit the hospital in a timely (T) manner] had the best OR [7.81 (5.93–10.44)] and sensitivity [0.81 (0.77–0.85)]. This mnemonic had equal sensitivity in men and women, the elderly and adults, smokers and non-smokers, and those with and without diabetes or hypertension.Conclusion: The “RUSH ChesT” mnemonic shows good diagnostic performance for patient suspected ACS. It may effectively help people memorize ACS warning symptoms.
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- 2023
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6. Impact of the adjunctive use criteria for intravascular ultrasound-guided percutaneous coronary intervention and clinical outcomes
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Pannipa Suwannasom, Ply Chichareon, Worawut Roongsangmanoon, Artit Thongtanomkul, Anuchit Wongpen, Muenpetch Muenkaew, Anek Kanoksilp, Mann Chandavimol, Srun Kuanprasert, Ammarin Thakkinstain, Suphot Srimahachota, and Nakarin Sansanayudh
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Medicine ,Science - Abstract
Abstract The impact of the adherence to the adjunctive use criteria (AUC) for intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI) and clinical outcomes in low IVUS volume countries are limited. The current study compared the procedural success and complication rates between used and not used IVUS catheter in the patients who were met (C +) and were not met (C−) the AUC for IVUS-guided PCI. From June 2018 through June 2019, a total of 21,066 patients were included in the Thai PCI registry. Among the study population, 15,966 patients (75.8%) have met the IVUS-AUC. The IVUS-guided PCI rates were 14.5% and 11.3% in the C + and C − groups, respectively. After adjusting for covariables by propensity model, IVUS-guided PCI was identified as an independent predictor of the procedural success rate regardless of whether the AUC were met with the relative risk [RR (95% confidence interval (CI)] of 1.033(1.026–1.040) and 1.012(1.002–1.021) in C + and C− groups, respectively. IVUS-guided PCI increased the procedural complication risks in both groups but were not significant with corresponding RRs of 1.171(0.915–1.426) and 1.693(0.959–2.426). Procedural success was achieved with IVUS-guided PCI regardless of whether the AUC were met. IVUS-guided PCI did not lead to an increase in procedural complications.
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- 2023
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7. Mortality risk and temporal patterns of atrial fibrillation in the nationwide registry
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Sirin Apiyasawat, Sakaorat Kornbongkotmas, Ply Chichareon, Rungroj Krittayaphong, and for the COOL‐AF Investigators
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atrial fibrillation ,atrial fibrillation type ,mortality ,registry ,stroke ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Aims Persistent and permanent atrial fibrillation (AF) often occurs in the presence of multiple comorbidities and is linked to adverse outcomes. It is unclear whether the sustained pattern of AF itself is prognostic or if it is confounded by underlying comorbidities. Here, we tested the association between the temporal patterns of AF and the risks of ischemic stroke and all‐cause mortality. Methods and Results In a prospective multicenter cohort, 3046 non‐valvular AF patients were consecutively enrolled and followed for adverse outcomes of all‐cause mortality and ischemic stroke. The risks of both outcomes were adjusted for underlying comorbidities, and compared between the patterns of AF. At baseline, the patients were classified as paroxysmal (N = 963, 31.6%), persistent (N = 604, 19.8%), and permanent AF (N = 1479, 45.6%) according to the standard definition. Anticoagulants were administered in 75% of all patients and 83% of those with CHA2DS2‐VASc score ≥2 in males or ≥3 in females. During a mean follow up of 26 (SD 10.5) months, all‐cause mortality occurred less in paroxysmal AF (2.5 per 100 patient‐years) than in persistent AF (4.4 per 100 patient‐years; adjusted hazard ratio [HR] 0.66, 95% CI, 0.46‐0.96; P = .029) and permanent AF (4.1 per 100 patient‐years; adjusted HR 0.71, 95% CI, 0.52‐0.98; P = .036). The risk of ischemic stroke was similar across all patterns of AF. Conclusions In this multicenter cohort of AF patients, persistent and permanent AF was associated with higher all‐cause mortality than paroxysmal AF, independent of baseline comorbidities. Clinical Trial Registration Thai Clinical Trial Registration; Study ID: TCTR20160113002 (http://www.thaiclinicaltrials.org/show/TCTR20160113002).
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- 2021
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8. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial
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Felice Gragnano, Marcel Zwahlen, Pascal Vranckx, Dik Heg, Kurt Schmidlin, Christian Hamm, Philippe Gabriel Steg, Giuseppe Gargiulo, Eugene P. McFadden, Yoshinobu Onuma, Ply Chichareon, Edouard Benit, Helge Möllmann, Luc Janssens, Sergio Leonardi, Aleksander Zurakowski, Alessio Arrivi, Robert Jan Van Geuns, Kurt Huber, Ton Slagboom, Paolo Calabrò, Patrick W. Serruys, Peter Jüni, Marco Valgimigli, and Stephan Windecker
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DAPT ,intention‐to‐treat ,P2Y12 inhibitor monotherapy ,per‐protocol ,ticagrelor ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P=0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P=0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.
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- 2022
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9. Author Correction: Impact of the adjunctive use criteria for intravascular ultrasound-guided percutaneous coronary intervention and clinical outcomes
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Pannipa Suwannasom, Ply Chichareon, Worawut Roongsangmanoon, Artit Thongtanomkul, Anuchit Wongpen, Muenpetch Muenkaew, Anek Kanoksilp, Mann Chandavimol, Srun Kuanprasert, Ammarin Thakkinstian, Suphot Srimahachota, and Nakarin Sansanayudh
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Medicine ,Science - Published
- 2023
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10. Advances in IVUS/OCT and Future Clinical Perspective of Novel Hybrid Catheter System in Coronary Imaging
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Masafumi Ono, Hideyuki Kawashima, Hironori Hara, Chao Gao, Rutao Wang, Norihiro Kogame, Kuniaki Takahashi, Ply Chichareon, Rodrigo Modolo, Mariusz Tomaniak, Joanna J. Wykrzykowska, Jan J. Piek, Isao Mori, Brian K. Courtney, William Wijns, Faisal Sharif, Christos Bourantas, Yoshinobu Onuma, and Patrick W. Serruys
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intravascular ultrasound ,optical coherence tomography ,hybrid IVUS–OCT catheter ,intracoronary imaging ,vulnerable plaque ,percutaneous coronary intervention ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been developed and improved as both diagnostic and guidance tools for interventional procedures over the past three decades. IVUS has a resolution of 100 μm with a high tissue penetration and capability of assessing the entire structure of a coronary artery including the external elastic membrane, whereas OCT has a higher resolution of 10–20 μm to assess endoluminal structures with a limited tissue penetration compared to IVUS. Recently, two companies, CONAVI and TERUMO, integrated IVUS and OCT into a single catheter system. With their inherent strength and limitations, the combined IVUS and OCT probes are complementary and work synergistically to enable a comprehensive depiction of coronary artery. In this review, we summarize the performance of the two intracoronary imaging modalities—IVUS and OCT—and discuss the expected potential of the novel hybrid IVUS–OCT catheter system in the clinical field.
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- 2020
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11. Predicting Infection Related Complications After Endovascular Repair of Infective Native Aortic Aneurysms
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Warissara Jutidamrongphan, Boonprasit Kritpracha, Karl Sörelius, Ply Chichareon, Virasakdi Chongsuvivatwong, Jitpreedee Sungsiri, Sorracha Rookkapan, Dhanakom Premprabha, Pong Juntarapatin, Wittawat Tantarattanapong, and Ruedeekorn Suwannanon
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Surgery ,Cardiology and Cardiovascular Medicine - Abstract
Endovascular aortic repair (EVAR) as surgical treatment for infective native aortic aneurysm (INAA) is associated with superior survival compared with open surgery, but with risk of infection-related complication (IRC). This study aimed to assess the association between baseline clinical and CT features and the risk of postoperative IRCs in patients treated with EVAR for INAA, and develop a model to predict long-term IRC in patients with abdominal INAA treated with EVAR.All initial clinical details and CT examinations of INAAs between 2005 and 2020 at a major referral hospital were retrospectively reviewed. The images were scrutinised according to aneurysm features, as well as periaortic and surrounding organ involvement. Data on postoperative IRC were found in the patient records. Cox regression model was used to derive predictors for IRC and develop a model to predict 5-year IRCs after EVAR in abdominal INAA.Out of 3780 patients with the diagnosis of aortic aneurysm or aortitis, 98 (3%) patients were treated with EVAR for abdominal INAAs and were thus included. The mean follow-up time was 52 months (range 0‒163). The mean transaxial diameters were 6.5 ± 2.4 cm (range 2.1‒14.7). In the enrolled patients, 38 (39%) presented with rupture. The rate of 5-year IRC in abdominal INAA was 26%. Female sex, renal insufficiency, positive blood culture, aneurysm diameter, and psoas muscle involvement were predictive for 5-year IRC in abdominal INAA after EVAR. The model had c-index of 0.76 (95%CI 0.66-0.87).Preoperative clinical and CT features have the potential to predict IRC after endovascular aortic repair in INAA patients. These findings stress the importance of rigorous clinical, laboratory, and radiological follow-up in these patients.
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- 2023
12. External Validation of the ACUITY/HORIZON Bleeding Risk Score among Acute Coronary Syndrome Patients in Thai PCI Registry
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Worawut Roongsangmanoon, Ply Chichareon, Teeranan Angkananard, Pannipa Suwannasom, Mann Chandavimol, Thosaphol Limpijankit, Suphot Srimahachota, Siriporn Athisakul, Pisit Hutayanon, Songsak Kiatchoosakun, Praprut Thanakitcharu, Montri Charoenpanichsunti, Prajongjit Chamsaard, Sukanya Siriyotha, Ammarin Thakkinstian, and Nakarin Sansanayudh
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Hematology - Abstract
Background External validation is essential before implementing a predictive model in clinical practice. This analysis validated the performance of the ACUITY/HORIZON risk score in the most contemporary Thai PCI registry. Methods The ACUITY/HORIZON model was applied and validated externally in 12,268 ACS (acute coronary syndrome) patients. For revision and updating models, the regression coefficientd of all predictors were re-estimated and then additional predictors were stepwise selected from multivariate analysis. Results In-hospital bleeding defined by the BARC (Bleeding Academic Research Consortium) criteria was 1.3% (161 patients) and 2.3% (285 patients) by the ACUITY criteria. The calibration of both scales demonstrated overestimation of the original model with C-statistic values of 0.704 for ACUITY major bleeding and 0.793 for BARC 3 or 5 bleeding. For ACUITY major bleeding, the discriminatory power of the update model improved substantially when congestive heart failure (CHF), prior vascular disease as well as body mass index were considered. The update model demonstrated good calibration and C-statistic of 0.747 and 0.745 with no white blood cell (WBC) count. For BARC 3 or 5 bleeding, good calibration and discriminatory capacity could be observed when CHF and prior vascular disease were added in the update models, with an excellent C-statistic of 0.838, and a lower C-statistic value of 0.835 was obtained in the absence of WBC count. Conclusion The ACUITY/HORIZON score was successfully validated in contemporary predictive and risk-adjustment models for PCI-related bleeding. The update models had good operating characteristics in patients from a real-world ACS population irrespective of bleeding definitions.
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- 2022
13. Comparative validation of HAS-BLED, GARFIELD-AF and ORBIT bleeding risk scores in Asian people with atrial fibrillation treated with oral anticoagulant:A report from the COOL-AF registry
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Ply Chichareon, Arjbordin Winijkul, Gregory Y. H. Lip, and Rungroj Krittayaphong
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Pharmacology ,anticoagulants ,cardiovascular ,cardiovascular pharmacology ,Pharmacology (medical) ,arrhythmia - Abstract
Aims: Comparative data between the HAS-BLED, GARFIELD-AF and ORBIT score are limited in anticoagulated Asian patients with atrial fibrillation (AF). We compared the performance of the 3 scores in a nationwide registry.Methods: AF patients treated with oral anticoagulants in the COOL-AF registry were studied. We fitted the variables of the HAS-BLED, GARFIELD-AF and ORBIT score to major bleeding in Cox model. We explored a modified HAS-BLED by addition of sex and body weight. Discrimination, calibration, net reclassification index (NRI) and decision curve analysis were used to compare the performance of the 3 models.Results: Of 3402 patients in the registry, 2568 patients who received oral anticoagulant at baseline were studied. Majority of patients (91.1%) received warfarin. The rate of major bleeding was 2.11 per 100 person-years. The C-statistics of the GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT score were 0.65 (95% confidence interval [CI] 0.63-0.67), 0.66 (95%CI 0.64-0.68), 0.69 (95%CI 0.67-0.71) and 0.64 (95%CI 0.62-0.66) respectively. There was good agreement between predicted and observed bleeding in the deciles of HAS-BLED and GARFIELD-AF scores, while the modified HAS-BLED score and ORBIT score overestimated the risk in the last decile. The modified HAS-BLED score had superior NRI than the HAS-BLED score (26.9%, 95%CI 9.7%-42.2%) and the ORBIT score (31.9%, 95%CI 9.0-53.6%). The NRI between the modified HAS-BLED and GARFIELD-AF score was similar. The net benefit curve of the 4 models were overlapping among different thresholds.Conclusions: The clinical utility for bleeding prediction of GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT scores were similar in anticoagulated Asian patients with AF participating in the COOL-AF registry. We found no advantage of the ORBIT over HAS-BLED score for bleeding risk prediction, even in direct oral anticoagulant users. Aims: Comparative data between the HAS-BLED, GARFIELD-AF and ORBIT score are limited in anticoagulated Asian patients with atrial fibrillation (AF). We compared the performance of the 3 scores in a nationwide registry.Methods: AF patients treated with oral anticoagulants in the COOL-AF registry were studied. We fitted the variables of the HAS-BLED, GARFIELD-AF and ORBIT score to major bleeding in Cox model. We explored a modified HAS-BLED by addition of sex and body weight. Discrimination, calibration, net reclassification index (NRI) and decision curve analysis were used to compare the performance of the 3 models.Results: Of 3402 patients in the registry, 2568 patients who received oral anticoagulant at baseline were studied. Majority of patients (91.1%) received warfarin. The rate of major bleeding was 2.11 per 100 person-years. The C-statistics of the GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT score were 0.65 (95% confidence interval [CI] 0.63-0.67), 0.66 (95%CI 0.64-0.68), 0.69 (95%CI 0.67-0.71) and 0.64 (95%CI 0.62-0.66) respectively. There was good agreement between predicted and observed bleeding in the deciles of HAS-BLED and GARFIELD-AF scores, while the modified HAS-BLED score and ORBIT score overestimated the risk in the last decile. The modified HAS-BLED score had superior NRI than the HAS-BLED score (26.9%, 95%CI 9.7%-42.2%) and the ORBIT score (31.9%, 95%CI 9.0-53.6%). The NRI between the modified HAS-BLED and GARFIELD-AF score was similar. The net benefit curve of the 4 models were overlapping among different thresholds.Conclusions: The clinical utility for bleeding prediction of GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT scores were similar in anticoagulated Asian patients with AF participating in the COOL-AF registry. We found no advantage of the ORBIT over HAS-BLED score for bleeding risk prediction, even in direct oral anticoagulant users.
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- 2023
14. Predicting Heart Failure in Patients with Atrial Fibrillation: A Report from the Prospective COOL-AF Registry
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Rungroj Krittayaphong, Ply Chichareon, Chulalak Komoltri, Poom Sairat, and Gregory Y. H. Lip
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heart failure ,predictive risk model ,atrial fibrillation ,General Medicine - Abstract
Background: This study aimed to determine risk factors and incidence rate and develop a predictive risk model for heart failure for Asian patients with atrial fibrillation (AF).Methods: This is a prospective multicenter registry of patients with non-valvular AF in Thailand conducted between 2014 and 2017. The primary outcome was the occurrence of an HF event. A predictive model was developed using a multivariable Cox-proportional model. The predictive model was assessed using C-index, D-statistics, Calibration plot, Brier test, and survival analysis.Results: There were a total of 3402 patients (average age 67.4 years, 58.2% male) with mean follow-up duration of 25.7 ± 10.6 months. Heart failure occurred in 218 patients during follow-up, representing an incidence rate of 3.03 (2.64-3.46) per 100 person-years. There were ten HF clinical factors in the model. The predictive model developed from these factors had a C-index and D-statistic of 0.756 (95% CI: 0.737-0.775) and 1.503 (95% CI: 1.372-1.634), respectively. The calibration plots showed a good agreement between the predicted and observed model with the calibration slope of 0.838. The internal validation was confirmed using the bootstrap method. The Brier score indicated that the model had a good prediction for HF.Conclusions: We provide a validated clinical HF predictive model for patients with AF, with good prediction and discrimination values. BACKGROUND: This study aimed to determine risk factors and incidence rate and develop a predictive risk model for heart failure for Asian patients with atrial fibrillation (AF).METHODS: This is a prospective multicenter registry of patients with non-valvular AF in Thailand conducted between 2014 and 2017. The primary outcome was the occurrence of an HF event. A predictive model was developed using a multivariable Cox-proportional model. The predictive model was assessed using C-index, D-statistics, Calibration plot, Brier test, and survival analysis.RESULTS: There were a total of 3402 patients (average age 67.4 years, 58.2% male) with mean follow-up duration of 25.7 ± 10.6 months. Heart failure occurred in 218 patients during follow-up, representing an incidence rate of 3.03 (2.64-3.46) per 100 person-years. There were ten HF clinical factors in the model. The predictive model developed from these factors had a C-index and D-statistic of 0.756 (95% CI: 0.737-0.775) and 1.503 (95% CI: 1.372-1.634), respectively. The calibration plots showed a good agreement between the predicted and observed model with the calibration slope of 0.838. The internal validation was confirmed using the bootstrap method. The Brier score indicated that the model had a good prediction for HF.CONCLUSIONS: We provide a validated clinical HF predictive model for patients with AF, with good prediction and discrimination values.
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- 2023
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15. Impact of white blood cell count on clinical outcomes in patients treated with aspirin-free ticagrelor monotherapy after percutaneous coronary intervention
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Mathias Vrolix, Joanna J. Wykrzykowska, Rutao Wang, Wolfgang Koenig, Ply Chichareon, Hironori Hara, Patrick W. Serruys, Chao Gao, Kurt Huber, Ramzi Khamis, Christian W. Hamm, Yoshinobu Onuma, Mariusz Tomaniak, Jan J. Piek, Masafumi Ono, Philippe Gabriel Steg, Global Leaders Study Investigators, Ranil de Silva, Hideyuki Kawashima, Stephan Windecker, Robert F. Storey, Pawel Jasionowicz, Peter Jüni, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and ACS - Heart failure & arrhythmias
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Ticagrelor ,medicine.medical_specialty ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Lower risk ,Percutaneous coronary intervention ,Leukocyte Count ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Clinical endpoint ,Humans ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Myocardial infarction ,White blood cell ,Inflammation ,Aspirin ,Ticagrelor monotherapy ,business.industry ,Hazard ratio ,Leucocyte ,medicine.disease ,Treatment Outcome ,Conventional PCI ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Aims The aim of this study was to investigate the efficacy and safety of ticagrelor monotherapy in patients undergoing percutaneous coronary intervention (PCI) stratified according to the baseline white blood cell (WBC) count. Methods and results This is a post hoc analysis of the GLOBAL LEADERS trial, a multi-centre, open-label, randomized all-comer trial in patients undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual anti-platelet therapy [DAPT]) with the reference strategy (12-month aspirin monotherapy following 12-month DAPT). Patients were stratified into two WBC groups, either < or ≥median WBC count of 7.8 × 109 cells/L (lower or higher WBC group, respectively). The primary endpoint was a composite of all-cause mortality or new Q-wave myocardial infarction at 2 years. Of 14 576 patients included in the present study, 7212 patients (49.5%) were classified as the lower WBC group, who had a significantly lower risk of both ischaemic and bleeding outcomes at 2 years. At 2 years, the experimental strategy was associated with a significant lower incidence of the primary endpoint compared with the reference strategy in the lower WBC group [2.8% vs. 4.2%; hazard ratio (HR): 0.67; 95% confidence interval (CI): 0.52–0.86] but not in the higher WBC group (4.8% vs. 4.7%; HR: 1.01; 95% CI: 0.82–1.25; Pinteraction=0.013). There were no significant differences in the risks of Bleeding Academic Research Consortium type 3 or 5 bleeding between two anti-platelet strategies regardless of the WBC groups. Conclusion Increased WBC counts, which may reflect degree of inflammation, at the time of index procedure may attenuate the anti-ischaemic benefits of ticagrelor monotherapy observed in patients with lower WBC counts.
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- 2022
16. Usefulness of the updated logistic clinical SYNTAX score after percutaneous coronary intervention in patients with prior coronary artery bypass graft surgery: Insights from the GLOBAL LEADERS trial
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Pascal Vranckx, Rutao Wang, Yoshinobu Onuma, Scot Garg, Stephan Windecker, Kuniaki Takahashi, Clemens Steinwender, Norihiro Kogame, Mariusz Tomaniak, Christian W. Hamm, Marco Valgimigli, Pedro Alves Lemos Neto, Hironori Hara, Masafumi Ono, Veselin Valkov, Chao Gao, Hideyuki Kawashima, Peter Jüni, Vasim Farooq, Ply Chichareon, Juergen vom Dahl, Carlos Macaya Miguel, Rodrigo Modolo, Tobias Geisler, Patrick W. Serruys, Philippe Gabriel Steg, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, ACS - Microcirculation, Cardiology, University of Zurich, and Serruys, Patrick W
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Male ,Time Factors ,medicine.medical_treatment ,Coronary Artery Disease ,risk stratification ,030204 cardiovascular system & hematology ,Coronary Angiography ,Coronary artery disease ,0302 clinical medicine ,Risk Factors ,030212 general & internal medicine ,Coronary Artery Bypass ,General Medicine ,Middle Aged ,humanities ,drug eluting ,Treatment Outcome ,medicine.anatomical_structure ,surgical procedures, operative ,coronary bypass grafts ,Cardiology ,Female ,percutaneous coronary intervention (PCI) ,Cardiology and Cardiovascular Medicine ,Artery ,medicine.medical_specialty ,610 Medicine & health ,Risk Assessment ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,Decision Support Techniques ,03 medical and health sciences ,Percutaneous Coronary Intervention ,Predictive Value of Tests ,Internal medicine ,medicine ,Humans ,2741 Radiology, Nuclear Medicine and Imaging ,Radiology, Nuclear Medicine and imaging ,In patient ,Aged ,Syntax (programming languages) ,business.industry ,Curve analysis ,Percutaneous coronary intervention ,Stent ,medicine.disease ,Conventional PCI ,stent ,business - Abstract
Objectives: We aimed to investigate the prognostic utility of the anatomical CABG SYNTAX and logistic clinical SYNTAX scores for mortality after percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafts (CABG). Background: The anatomical SYNTAX score evaluated the anatomical complexity of coronary artery disease and helped predict the prognosis of patients undergoing PCI. The anatomical CABG SYNTAX score was derived from the anatomical SYNTAX score in patients with prior CABG, whilst the logistic clinical SYNTAX score was developed by incorporating clinical factors into the anatomical SYNTAX score. Methods: We calculated the anatomical CABG SYNTAX score and logistic clinical SYNTAX score in 205 patients in the GLOBAL LEADERS trial. The predictive abilities of these scores for 2-year all-cause mortality were evaluated. Results: Using the median scores as categorical thresholds between low and high score groups, the logistic clinical SYNTAX score was able to discriminate the risk of 2-year mortality, unlike the anatomical CABG SYNTAX score. The logistic clinical SYNTAX was significantly better at predicting 2-year mortality, compared to the anatomical CABG SYNTAX score, as evidenced by AUC values in receiver-operating characteristic curve analysis (0.806 vs. 0.582, p
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- 2020
17. Procedural success and outcomes after percutaneous balloon mitral valvuloplasty in rheumatic mitral stenosis with moderate mitral regurgitation: a retrospective cohort study
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Ply Chichareon, Thanapon Nilmoje, Saranyou Suwanugsorn, Noppadol Chamnarnphol, Metus Thungthienthong, Sarayuth Lucien Geater, and Woravut Jintapakorn
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Cardiology and Cardiovascular Medicine - Abstract
Percutaneous balloon mitral valvuloplasty (PBMV) is contraindicated in mitral stenosis (MS) with moderate mitral regurgitation (MR) according to the European guidelines. However, small-sized studies have demonstrated the feasibility and safety of PBMV in these patients. We aimed to study the procedural success and mid-term outcomes of PBMV in MS patients with moderate MR.The present study was a retrospective cohort study in consecutive patients with severe rheumatic MS who underwent PBMV with the Inoue technique in Songklanagarind hospital. The severity of mitral regurgitation was assessed with qualitative Doppler. The patients were grouped according to their MR severity before PBMV into moderate MR or less-than-moderate MR. Procedural success and a composite of all-cause death, mitral valve surgery or re-PBMV were compared between the two groups.Of 618 patients with rheumatic MS who underwent PBMV in Songklanagarind hospital between January 2003 and October 2020, 598 patients (96.8%) had complete information of pre-PBMV MR severity and procedural success. Forty-nine patients (8.2%) had moderate MR before PBMV. Moderate MR before PBMV was not associated with a lower chance of PBMV success (moderate MRPBMV is an effective and safe treatment in rheumatic MS with moderate MR.
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- 2022
18. Prevalence and predictors associated with in-hospital mortality in acute ST segment elevation myocardial infarction after reperfusion therapy in developing country
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Chorchana Wichian, Thanapon Nilmoje, Thotsaporn Morasert, and Ply Chichareon
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medicine.medical_specialty ,education.field_of_study ,Ejection fraction ,business.industry ,Cardiogenic shock ,medicine.medical_treatment ,Population ,Percutaneous coronary intervention ,030204 cardiovascular system & hematology ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Reperfusion therapy ,Internal medicine ,Conventional PCI ,medicine ,Cardiology ,Original Article ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,education ,Kidney disease - Abstract
Background The prevalence and predictors of in-hospital mortality in the unselected patients with ST-segment elevation myocardial infarction (STEMI) after reperfusion therapy with fibrinolytic or primary percutaneous coronary intervention (PCI) in developing country have not well established. Methods We conducted a retrospective cohort study design. All admission records of acute ST elevation myocardial infarction at Suratthani Hospital between October 2015 and September 2017. Results The finding between October 2015 and September 2017, a total of 431 patients received reperfusion therapy and were included in the present study. Majority of the patient were male (80.5%), almost half of the population had anterior wall MI, 32 patients died (7.4%), and 399 survived during the index hospitalization. The prevalence of chronic kidney disease, anterior wall MI, cardiogenic shock and cardiac arrest in non-survived group was higher than the survived group. Echocardiogram was performed in 299 patient (69.4%) and the median left ventricular ejection fraction (LVEF) in overall population was 51%. After adjustment for baseline variables, LVEF (aOR 0.91, 95% CI, 0.83-0.98, P=0.02) and cardiac arrest at presentation (aOR 22, 95% CI, 1.22-410.05, P=0.036) were independently associated with in-hospital mortality. Conclusions LVEF and cardiac arrest at presentation were independently associated with in-hospital mortality in STEMI patients receiving reperfusion therapy either fibrinolytic therapy or primary PCI.
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- 2020
19. Treatment with a dedicated bifurcation sirolimus-eluting cobalt-chromium stent for distal left main coronary artery disease: rationale and design of the POLBOS LM study
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Norihiro Kogame, Franck Digne, Thierry Lefèvre, Robert J. Gil, Ply Chichareon, Yoshinobu Onuma, Patrick W. Serruys, Jacek Legutko, Taku Asano, Rodrigo Modolo, Marie-Angèle Morel, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Microcirculation
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Chromium ,medicine.medical_specialty ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary Angiography ,Prosthesis Design ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Intravascular ultrasound ,Left main ,Clinical endpoint ,medicine ,Humans ,Prospective Studies ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Prospective cohort study ,Stroke ,Sirolimus ,medicine.diagnostic_test ,business.industry ,Coronary Stenosis ,Percutaneous coronary intervention ,Stent ,Drug-Eluting Stents ,Cobalt ,medicine.disease ,Treatment Outcome ,Conventional PCI ,Stents ,Bifurcation ,Radiology ,Drug-eluting stent ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aims The aim of this study is to demonstrate the non-inferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the XIENCE stent regarding the patient-oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA). Methods and results The POLBOS LM study is a single-arm, prospective, multicentre study enrolling 260 patients (SYNTAX score ≤32) with a pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrolment will comply with objective inclusion criteria of diameter stenosis ≥50% in the LMCA based on off-line quantitative coronary angiography (QCA) analysed by an independent core laboratory using dedicated bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the same specific technical classification as for the BiOSS LIM (modified MADS classification) and the stent implantation is optimised by using pre-specified intravascular ultrasound criteria. The primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularisation) at 12 months. Conclusions The POLBOS LM study will indicate the efficacy of the BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.
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- 2020
20. Clinical relevance of ticagrelor monotherapy following 1-month dual antiplatelet therapy after bifurcation percutaneous coronary intervention: Insight from GLOBAL LEADERS trial
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Luc Janssens, Hans Peter Stoll, Pascal Vranckx, Marco Valgimigli, Antonio Colombo, Hidenori Komiyama, Peter Jüni, Ply Chichareon, Stephan Windecker, Philippe Gabriel Steg, Chun Chin Chang, Kenneth De Wilder, Norihiro Kogame, Yves Louvard, Alaide Chieffo, Mariusz Tomaniak, Yoshinobu Onuma, Scot Garg, Kuniaki Takahashi, Christian W. Hamm, Rodrigo Modolo, Patrick W. Serruys, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, ACS - Microcirculation, Cardiology, University of Zurich, Serruys, Patrick W, Kogame, Norihiro, Chichareon, Ply, De Wilder, Kenneth, Takahashi, Kuniaki, Modolo, Rodrigo, Chang, Chun Chin, Tomaniak, Mariusz, Komiyama, Hidenori, Chieffo, Alaide, Colombo, Antonio, Garg, Scot, Louvard, Yves, Juni, Peter, Steg, Philippe G., Hamm, Christian, VRANCKX, Pascal, Valgimigli, Marco, Windecker, Stephan, Stoll, Hans-Peter, Onuma, Yoshinobu, Janssens, Luc, and Serruys, Patrick W.
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Male ,Ticagrelor ,Time Factors ,medicine.medical_treatment ,Myocardial Infarction ,030204 cardiovascular system & hematology ,antiplatelet treatment ,bifurcation lesion ,drug-eluting stents ,Percutaneous coronary intervention ,0302 clinical medicine ,Recurrence ,Risk Factors ,Clinical endpoint ,030212 general & internal medicine ,Myocardial infarction ,Prospective Studies ,610 Medicine & health ,Aspirin ,Dual Anti-Platelet Therapy ,Hazard ratio ,General Medicine ,Middle Aged ,Treatment Outcome ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,medicine.drug ,medicine.medical_specialty ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,Drug Administration Schedule ,03 medical and health sciences ,Internal medicine ,medicine ,2741 Radiology, Nuclear Medicine and Imaging ,Humans ,Radiology, Nuclear Medicine and imaging ,Aged ,business.industry ,Stent ,medicine.disease ,Conventional PCI ,Purinergic P2Y Receptor Antagonists ,business ,Platelet Aggregation Inhibitors - Abstract
Background The aim of this study was to investigate the impact of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for bifurcation lesions. Methods GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing 1-month DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. The primary endpoint was a composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years. Results Among the 15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion. The incidence of the primary endpoint was similar between the bifurcation and nonbifurcation groups (4.7 vs. 4.0%, p = .083). The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment. Conclusions After PCI for bifurcation lesions using 1-month of DAPT followed by ticagrelor monotherapy for 23 months did not demonstrate explicit benefit regarding all-cause death or new Q-wave MI as in the overall trial. AstraZeneca; Biosensors International Group; Medicines company
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- 2020
21. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial
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Norihiro Kogame, Krzysztof J. Filipiak, Mariusz Tomaniak, Franz-Josef Neumann, Osama Ibrahim Ibrahim Soliman, Valeri Gelev, Ply Chichareon, Robert-Jan van Geuns, Jan G.P. Tijssen, Philippe Brunel, Zoltan Jambrik, Yoshinobu Onuma, Global Leaders Study Investigators, Jean-François Morelle, Rodrigo Modolo, Chun Chin Chang, Patrick W. Serruys, Mariana Konteva, Tessa Rademaker-Havinga, Marco Valgimigli, Sylvain Plante, Philippe Gabriel Steg, Stephan Windecker, Ernest Spitzer, Kuniaki Takahashi, Farzin Beygui, Rosana Hernandez Antolin, Robert F. Storey, Christian W. Hamm, Cardiology, Graduate School, ACS - Heart failure & arrhythmias, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and University of Zurich
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Male ,Ticagrelor ,Time Factors ,medicine.medical_treatment ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Percutaneous coronary intervention ,Pulmonary Disease, Chronic Obstructive ,0302 clinical medicine ,Risk Factors ,Aspirin-free antiplatelet strategies after percutaneous coronary intervention ,Clinical endpoint ,2736 Pharmacology (medical) ,Pharmacology (medical) ,Prospective Studies ,030212 general & internal medicine ,Myocardial infarction ,610 Medicine & health ,COPD ,Dual Anti-Platelet Therapy ,Incidence ,Chronic obstructive pulmonary disease ,Hazard ratio ,Middle Aged ,Treatment Outcome ,Female ,Cardiology and Cardiovascular Medicine ,medicine.drug ,medicine.medical_specialty ,Risk Assessment ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,Drug Administration Schedule ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Aged ,business.industry ,medicine.disease ,Dyspnoea adverse event ,Clinical trial ,Dyspnea ,Conventional PCI ,business ,Platelet Aggregation Inhibitors - Abstract
Aims To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. Methods and results This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21–3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58–1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. Conclusion In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. Clinical trial registration unique identifier NCT01813435.
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- 2020
22. Comparative Assessment of Predictive Performance of PRECISE-DAPT, CRUSADE, and ACUITY Scores in Risk Stratifying 30-Day Bleeding Events
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Ply Chichareon, Richard D. Anderson, Masafumi Ono, Robbert J. de Winter, Philippe Gabriel Steg, Patrick W. Serruys, René Koning, Hironori Hara, James Cotton, Kuniaki Takahashi, Rutao Wang, Mariusz Tomaniak, Scot Garg, Joanna J. Wykrzykowska, Hideyuki Kawashima, Simon J Walsh, Chao Gao, Yoshinobu Onuma, Harry Suryapranata, Benno J. Rensing, Christian W. Hamm, Graduate School, ACS - Atherosclerosis & ischemic syndromes, Cardiology, and ACS - Heart failure & arrhythmias
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Male ,medicine.medical_specialty ,Time Factors ,Post hoc ,medicine.medical_treatment ,Population ,Hemorrhage ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Risk Assessment ,Decision Support Techniques ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,Cellular Haemostasis and Platelets ,Medicine ,Humans ,In patient ,bleeding scores ,030212 general & internal medicine ,Acute Coronary Syndrome ,education ,Aged ,education.field_of_study ,business.industry ,Dual Anti-Platelet Therapy ,percutaneous coronary intervention ,Percutaneous coronary intervention ,Hematology ,Middle Aged ,calibration ,Treatment Outcome ,dual-antiplatelet therapy ,Integrated discrimination improvement ,major bleeding ,Chronic Disease ,Female ,business ,Major bleeding ,discrimination - Abstract
Background The utility of the PRECISE-DAPT score in predicting short-term major bleeding, either alone, or in comparison with the CRUSADE and ACUITY scores, has not been investigated. This analysis compared the predictive performances of the three bleeding scores in stratifying the risk of 30-day major bleeding postpercutaneous coronary intervention in patients with dual-antiplatelet therapy.Methods In this post hoc subanalysis of the GLOBAL LEADERS trial, the primary safety objective (bleeding according to the Bleeding Academic Research Consortium [BARC] criteria [type 3 or 5]) was assessed at 30 days according to the three scores in the overall population, and in patients with acute (ACS) and chronic coronary syndrome (CCS).Results In a total of 15,968 patients, we calculated all three scores in 14,709 (92.1%). Irrespective of clinical presentation, the PRECISE-DAPT (c-statistics: 0.648, 0.653, and 0.641, respectively), CRUSADE (c-statistics: 0.641, 0.639, and 0.644, respectively), and ACUITY (c-statistics: 0.633, 0.638, and 0.623, respectively) scores were no significant between-score differences in discriminatory performance for BARC 3 or 5 bleeding up to 30 days, and similarly the PRECISE-DAPT score had a comparable discriminative capacity according to the integrated discrimination improvement when compared with the other scores. In ACS, the CRUSADE score had a poor calibration ability (Hosmer–Lemeshow goodness-of-fit [GOF] chi-square = 15.561, p = 0.049), whereas in CCS, the PRECISE-DAPT score had poor calibration (GOF chi-square = 15.758, p = 0.046).Conclusion The PRECISE-DAPT score might be clinically useful in the overall population and ACS patients for the prediction of short-term major bleeding considering its discriminative and calibration abilities.
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- 2020
23. Twilight, the Dawn of a New Era of Aspirin-Free PCI?
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Patrick W. Serruys, Ply Chichareon, Kuniaki Takahashi, Yoshinobu Onuma, Graduate School, ACS - Heart failure & arrhythmias, ACS - Atherosclerosis & ischemic syndromes, and ACS - Microcirculation
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medicine.medical_specialty ,Aspirin ,Twilight ,business.industry ,medicine.disease ,dual antiplatelet therapy ,Internal medicine ,Diabetes mellitus ,Conventional PCI ,complex PCI ,diabetes mellitus ,Cardiology ,Medicine ,ticagrelor monotherapy ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Published
- 2020
24. The impact of plaque type on strut embedment/protrusion and shear stress distribution in bioresorbable scaffold
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Hans Jonker, Kuniaki Takahashi, Yoshinobu Onuma, Rodrigo Modolo, Christos V. Bourantas, Kerem Pekkan, Ply Chichareon, Jouke Dijkstra, Yuki Katagiri, Ryo Torii, Robert Jan van Geuns, Patrick W. Serruys, Yohei Sotomi, Taku Asano, Erhan Tenekecioglu, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, Surgery, and Cardiology
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030204 cardiovascular system & hematology ,atherosclerotic plaque ,Coronary Angiography ,Prosthesis Design ,shear stress ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Absorbable Implants ,Fibrous plaque ,medicine ,Shear stress ,strut embedment ,Humans ,Radiology, Nuclear Medicine and imaging ,medicine.diagnostic_test ,Embedment ,business.industry ,General Medicine ,Blood flow ,bioresorbable scaffold ,medicine.disease ,Coronary Vessels ,Plaque, Atherosclerotic ,Coronary arteries ,medicine.anatomical_structure ,Atheroma ,Angiography ,cardiovascular system ,strut protrusion ,Cardiology and Cardiovascular Medicine ,business ,Tomography, Optical Coherence ,Bioresorbable scaffold ,Biomedical engineering - Abstract
AIMS: Scaffold design and plaque characteristics influence implantation outcomes and local flow dynamics in treated coronary segments. Our aim is to assess the impact of strut embedment/protrusion of bioresorbable scaffold on local shear stress distribution in different atherosclerotic plaque types. METHODS AND RESULTS: Fifteen Absorb everolimus-eluting Bioresorbable Vascular Scaffolds were implanted in human epicardial coronary arteries. Optical coherence tomography (OCT) was performed post-scaffold implantation and strut embedment/protrusion were analysed using a dedicated software. OCT data were fused with angiography to reconstruct 3D coronary anatomy. Blood flow simulation was performed and wall shear stress (WSS) was estimated in each scaffolded surface and the relationship between strut embedment/protrusion and WSS was evaluated. There were 9083 struts analysed. Ninety-seven percent of the struts (n = 8840) were well-apposed and 243 (3%) were malapposed. At cross-section level (n = 1289), strut embedment was significantly increased in fibroatheromatous plaques (76 ± 48 µm) and decreased in fibrocalcific plaques (35 ± 52 µm). Compatible with strut embedment, WSS was significantly higher in lipid-rich fibroatheromatous plaques (1.50 ± 0.81 Pa), whereas significantly decreased in fibrocalcified plaques (1.05 ± 0.91 Pa). After categorization of WSS as low (
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- 2020
25. The influence of implantation techniques on lesion oriented-outcomes in Absorb BVS and Xience EES lesions treated in routine clinical practice at complete three year follow-up: AIDA trial QCA substudy
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Yohei Sotomi, Deborah N. Kalkman, E. Karin Arkenbout, Jan J. Piek, Martina Nassif, Taku Asano, Ruben Y.G. Tijssen, Jan G.P. Tijssen, Carlos Collet, Ply Chichareon, Rodrigo Modolo, Patrick W. Serruys, Auke P.J.D. Weevers, Joanna J. Wykrzykowska, Robbert J. de Winter, Yoshinobu Onuma, Sjoerd H. Hofma, Norihiro Kogame, José P.S. Henriques, Laura S.M. Kerkmeijer, Yuki Katagiri, Kuniaki Takahashi, René J. van der Schaaf, Robin P. Kraak, Graduate School, Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Microcirculation
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medicine.medical_specialty ,Time Factors ,Myocardial Infarction ,Target vessel ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary Angiography ,Prosthesis Design ,Lesion ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Quantitative coronary angiography ,Absorbable Implants ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,Routine clinical practice ,030212 general & internal medicine ,Myocardial infarction ,Angioplasty, Balloon, Coronary ,Pump thrombosis ,Target lesion revascularization ,business.industry ,Composite outcomes ,Drug-Eluting Stents ,Thrombosis ,medicine.disease ,Drug eluting stents ,Coronary Vessels ,Current analysis ,Treatment Outcome ,Bioresorbable scaffolds ,Radiology ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - Abstract
It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.
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- 2020
26. Preclinical evaluation of a thin-strut bioresorbable scaffold (ArterioSorb): acute-phase invasive imaging assessment and hemodynamic implication
- Author
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Rasha Al-Lamee, Erhan Tenekecioglu, Joanna J. Wykrzykowska, Taku Asano, Christos V. Bourantas, Jan J. Piek, Nial Bullett, Mariusz Tomaniak, Pieter H. Kitslaar, Jouke Dijkstra, Yuki Katagiri, Eric K. W. Poon, Patrick W. Serruys, Ryo Torii, Guy Leclerc, Kadem Al-Lamee, Kuniaki Takahashi, Yoshinobu Onuma, Naveed Ahmed, Frank J. H. Gijsen, Ply Chichareon, Johan H. C. Reiber, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Cardiology, and ACS - Heart failure & arrhythmias
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Scaffold ,Swine ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Coronary Angiography ,Prosthesis Design ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Optical coherence tomography ,Absorbable Implants ,medicine ,Animals ,030212 general & internal medicine ,QCA ,medicine.diagnostic_test ,business.industry ,Hemodynamics ,Percutaneous coronary intervention ,Stent ,Drug-Eluting Stents ,Coronary Vessels ,Coronary arteries ,medicine.anatomical_structure ,Treatment Outcome ,Drug-eluting stent ,Bioresorbable scaffolds ,Tomography ,Cardiology and Cardiovascular Medicine ,business ,Tomography, Optical Coherence ,Biomedical engineering ,Artery - Abstract
AIMS: The aim of this study was to assess the acute performance of the 95 µm ArterioSorb oriented poly L-lactic acid (PLLA) scaffold in comparison with the XIENCE metallic drug-eluting stent (DES) in porcine coronary arteries. METHODS AND RESULTS: In 15 non-atherosclerotic Yucatan mini pigs, the ArterioSorb (3.0/14 mm) and XIENCE (3.0/15 mm) were implanted in 25 and 15 vessels, respectively. Acute performance was evaluated by using quantitative coronary angiography (QCA) and optical coherence tomography (OCT). Following three-dimensional reconstruction of the coronary arteries, endothelial shear stress (ESS) was quantified using non-Newtonian steady-flow simulation. Acute recoil measured by QCA was comparable in the two arms. Post-procedural flow and scaffold/stent area by OCT did not differ between the two devices. ESS post procedure was comparable between ArterioSorb and XIENCE (2.21±1.97 vs 2.25±1.71 Pa, p=0.314). CONCLUSIONS: Acute recoil, luminal dimensions and ESS in the ArterioSorb oriented PLLA scaffold with thin struts of 95 µm were comparable to those in the XIENCE metallic DES.
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- 2020
27. Association between post-percutaneous coronary intervention bivalirudin infusion and net adverse clinical events: a post hoc analysis of the GLOBAL LEADERS study
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Philippe Gabriel Steg, Kees-Jan Royaards, Chao Gao, Rod Stables, Ply Chichareon, Rodrigo Modolo, Peter Jüni, Mariusz Tomaniak, Patrick W. Serruys, Christian W. Hamm, Chun Chin Chang, Angel Cequier, Marco Valgimigli, Yoshinobu Onuma, Robert-Jan van Geuns, Stephan Windecker, Keith G. Oldroyd, Kuniaki Takahashi, Norihiro Kogame, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, Cardiology, University of Zurich, and Serruys, Patrick W
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Stent thrombosis ,medicine.medical_treatment ,Population ,610 Medicine & health ,Hemorrhage ,Risk Assessment ,Coronary artery disease ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,Antithrombins ,Percutaneous Coronary Intervention ,Risk Factors ,Internal medicine ,Infusion Procedure ,Clinical endpoint ,medicine ,2736 Pharmacology (medical) ,Humans ,Bivalirudin ,Pharmacology (medical) ,cardiovascular diseases ,Myocardial infarction ,education ,Aged ,Randomized Controlled Trials as Topic ,education.field_of_study ,business.industry ,Coronary Thrombosis ,Percutaneous coronary intervention ,Hirudins ,Middle Aged ,medicine.disease ,Peptide Fragments ,Recombinant Proteins ,Treatment Outcome ,Conventional PCI ,Cardiology ,ST Elevation Myocardial Infarction ,Female ,Stents ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Aims The efficacy and safety of continued bivalirudin infusion after percutaneous coronary intervention (PCI) remains uncertain. We sought to investigate the association between post-PCI bivalirudin infusion and the risk of net adverse clinical events (NACE) at 30 days. Methods and results In the GLOBAL LEADERS study, all patients who received bivalirudin during PCI were categorized according to the use of bivalirudin infusion after the procedure. The primary endpoint of the present analysis was NACE [a composite of all-cause death, any stroke, any myocardial infarction, all revascularization, and bleeding assessed according to the Bleeding Academic Research Consortium (BARC) criteria Type 3 or 5] at 30 days. The key safety endpoint was BARC Type 3 or 5 bleeding and definite stent thrombosis. Of 15 968 patients, 13 870 underwent PCI with the use of bivalirudin. In total, 7148 patients received continued bivalirudin infusion after procedure, while 6722 patients received standard care. After propensity score covariate adjustment, the risk of NACE did not significantly differ between two treatments after PCI [continued bivalirudin infusion vs. no bivalirudin infusion: 3.2% vs. 3.1%, adjusted hazard ratio (aHR) 1.35, 95% confidence interval (CI) 0.99–1.84, P = 0.06] nor the BARC Type 3 or 5 bleeding (0.7% vs. 0.7%, aHR 0.89, 95% CI 0.44–1.79; P = 0.743) and definite stent thrombosis (0.5% vs. 0.3%, aHR 1.71, 95% CI 0.77–3.81, P = 0.189). However, continued bivalirudin infusion was associated with an increased risk of NACE and definite stent thrombosis in ST-elevation myocardial infarction (STEMI) patients. Conclusion In an all-comers population undergoing PCI, there was no significant difference in the risk of NACE at 30 days between continued bivalirudin infusion vs. no bivalirudin infusion after procedure but continued bivalirudin infusion was associated with a higher risk of NACE in STEMI patients when compared with no infusion.
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- 2019
28. Prognostic Value of Ankle-Brachial Index in Prediction of Cardiovascular Events in an Asian Population with Multiple Atherosclerotic Risk Factors
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Pannipa, Suwannasom, Phichayut, Phinyo, Krit, Leemasawat, Ply, Chichareon, Teerapat, Nantsupawat, Nichanan, Osataphan, Tasalak, Thonghong, Saranyou, Suwanugsorn, Chaiyasith, Wongvipaporn, and Arintaya, Phrommintikul
- Subjects
Cardiology and Cardiovascular Medicine - Abstract
We aimed to evaluate the incremental prognostic value after incorporation of the ankle-brachial index (ABI) into the 10-year pool cohort equation (PCE) risk model in patients with multiple risk factors (MRFs). A total of 4332 MRFs patients were divided into 2 groups as ABI ≤.9 or >.9. The primary outcome was hard cardiovascular events (hCVE: including cardiovascular death, myocardial infarction, or ischemic stroke) over a median follow-up of 36 months. The Cox proportional hazards survival model, C-statistic, and net reclassification indices (NRI) were used. The occurrence of the primary outcome in the ABI ≤.9 group (3.7%) was significantly greater than in the ABI > .9 group (1.3%), P < .001. ABI is an independent predictor of hCVE in addition to the variables in the standard risk model (age, gender, and smoking status). ABI modestly improved the C-index when added to the PCE risk model (PCE .70 vs ABI+PCE .74). The addition of ABI to the PCE risk model did not significantly improve the classification of patients (NRI -.029; 95% CI: −.215 to .130). Despite ABI being one of the independent predictors of hCVE, integration of ABI into the PCE model did not improve the efficacy of risk reclassification in patients with MRFs.
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- 2022
29. Predicting mortality in cardiac care unit patients: external validation of the Mayo cardiac intensive care unit admission risk score
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Ittipon Preechawettayakul, Ply Chichareon, Thanapon Nilmoje, Saranyou Suwanugsorn, and Wisanuwee Suriyaamorn
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medicine.medical_specialty ,Population ,Aftercare ,Critical Care and Intensive Care Medicine ,Risk Assessment ,law.invention ,law ,Risk Factors ,Medicine ,Humans ,Hospital Mortality ,education ,Aged ,Retrospective Studies ,education.field_of_study ,Framingham Risk Score ,business.industry ,Mortality rate ,Cardiogenic shock ,General Medicine ,medicine.disease ,Intensive care unit ,Patient Discharge ,Cardiac surgery ,Intensive Care Units ,Respiratory failure ,Emergency medicine ,Coronary care unit ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aims The Mayo Cardiac Intensive Care Unit Admission Risk Score (M-CARS) had excellent performance in predicting in-hospital mortality in the US population. We sought to validate the M-CARS for in-hospital and post-discharge mortality in Asian patients admitted to the cardiac care unit (CCU). Methods and results Patients admitted to the CCU of a tertiary care centre between July 2015 and December 2019 were included into the study. Patients with intra-hospital transfer to the CCU due to intensive care unit overflow, postoperative cardiac surgery, or for monitoring after elective procedures were excluded. Cardiac arrest, cardiogenic shock, respiratory failure, Braden skin score, blood urea nitrogen, anion gap, and red cell distribution width, were used to calculate the M-CARS. Patients were stratified into three groups, according to the M-CARS (6). Of 1988 patients in the study, 30.1% were female with a median age of 65 years. Prevalence of cardiogenic shock and respiratory failure at admission were 2.8% and 4.5%, respectively. One hundred and seventeen patients died during the admission (mortality rate of 5.9%). The in-hospital mortality rate in patients with M-CARS of 6 was 1.1%, 9.8%, and 35.5%, respectively. C-statistic of M-CARS for in-hospital mortality was 0.840 (95% CI 0.805–0.873); whereas, it was 0.727 (95% CI 0.690–0.761) for 1-year post-discharge mortality. Calibration plot showed good agreement between predicted and observed in-hospital mortality in the majority of patients. Conclusions The M-CARS was useful in our study, in terms of discrimination and calibration. M-CARS identified high-risk patients in CCU, who had unacceptably high mortality rate during hospital stay and thereafter.
- Published
- 2021
30. Clinical Implication of Quantitative Flow Ratio After Percutaneous Coronary Intervention for 3-Vessel Disease
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Adrian P. Banning, Yoshinobu Onuma, Hidenori Komiyama, Rod Stables, Manel Sabaté, Jan J. Piek, Rodrigo Modolo, Vasim Farooq, Kuniaki Takahashi, Farzin Fath-Ordoubadi, Yuki Katagiri, Justin E. Davies, Chun Chin Chang, Patrick W. Serruys, Ply Chichareon, Simon J Walsh, Javier Escaned, Norihiro Kogame, Mariusz Tomaniak, Taku Asano, Johan H. C. Reiber, Robert-Jan van Geuns, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, ACS - Microcirculation, and Cardiology
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Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,drug-eluting stent ,Clinical endpoint ,Humans ,Medicine ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Aged ,Retrospective Studies ,Clinical Trials as Topic ,quantitative flow ratio ,business.industry ,percutaneous coronary intervention ,Hazard ratio ,Percutaneous coronary intervention ,Middle Aged ,medicine.disease ,Coronary Vessels ,Confidence interval ,Cardiac surgery ,Fractional Flow Reserve, Myocardial ,Treatment Outcome ,surgical procedures, operative ,Drug-eluting stent ,Conventional PCI ,Cardiology ,Female ,Stents ,Cardiology and Cardiovascular Medicine ,business - Abstract
OBJECTIVES The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel disease (3VD) treated with contemporary PCI.BACKGROUND The clinical impact of post-PCI QFR in patients treated with state-of-the-art PCI for de novo 3VD is undetermined.METHODS All vessels treated in the SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) II trial were retrospectively screened and analyzed for post-PCI QFR. The primary endpoint of this substudy was vessel-oriented composite endpoint (VOCE) at 2 years, defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction, and target vessel revascularization. The receiver-operating characteristic curve was used to calculate the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE. All the analyzable vessels were stratified on the basis of the optimal cutoff value.RESULTS A total of 968 vessels treated with PCI were screened. Post-PCIQFR was analyzable in 771 (79.6%) vessels. A total of 52 (6.7%) VOCEs occurredat 2 years. The mean value of post-PCIQFR was 0.91 +/- 0.07. The diagnostic performance of post-PCI QFR to predict 2-year VOCE was moderate (area under the curve: 0.702; 95% confidence interval: 0.633 to 0.772), with the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE 0.91 (sensitivity 0.652, specificity 0.635). The incidence of 2-year VOCE in the vessels with post-PCIQFR= 0.91 (n = 487) (12.0% vs. 3.7%; hazard ratio: 3.37; 95% confidence interval: 1.91 to 5.97; p < 0.001).CONCLUSIONS A higher post-PCI QFR value is associated with improved vessel-related clinical outcomes in state-of the art PCI practice for de novo 3VD. Achieving a post-PCI QFR value >= 0.91 in all treated vessels should be a target when treating de novo 3VD. These findings require confirmation in future prospective trials. (C) 2019 by the American College of Cardiology Foundation.
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- 2019
31. A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX
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Gerrit Anne van Es, Taku Asano, Chun-Chin Chang, Rodrigo Modolo, Norihiro Kogame, Robbert J. de Winter, Yuki Katagiri, Patrick W. Serruys, Upendra Kaul, Yoshinobu Onuma, Osama Ibrahim Ibrahim Soliman, Marie-Angèle Morel, Ply Chichareon, Azfar Zaman, Kuniaki Takahashi, Ernest Spitzer, Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Graduate School, and ACS - Heart failure & arrhythmias
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Population ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Coronary stent ,Absorbable Implants ,medicine ,Clinical endpoint ,Humans ,Single-Blind Method ,030212 general & internal medicine ,Myocardial infarction ,Everolimus ,Prospective Studies ,education ,Sirolimus ,education.field_of_study ,business.industry ,Stent ,Percutaneous coronary intervention ,Drug-Eluting Stents ,medicine.disease ,Surgery ,Europe ,Treatment Outcome ,Stents ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Aims: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a noninferiority trial in a “real-world” patient population. Methods and results: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an “allcomers” patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). Conclusions: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.
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- 2019
32. How does the failure of absorb apply to the other bioresorbable scaffolds? An expert review of first-in-man and pivotal trials
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Yoshinobu Onuma, Yosuke Miyazaki, Jan J. Piek, Kuniaki Takahashi, Ply Chichareon, Norihiro Kogame, Taku Asano, Rodrigo Modolo, Joanna J. Wykrzykowska, Yuki Katagiri, Patrick W. Serruys, and Cardiology
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business.industry ,Thrombogenicity ,Dentistry ,Cardiovascular Agents ,Class effect ,030204 cardiovascular system & hematology ,Coronary Angiography ,Prosthesis Design ,Coronary Vessels ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Clinical evidence ,Optical Coherence ,Absorbable Implants ,Medicine ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business ,Tomography ,Bioresorbable scaffold ,Tomography, Optical Coherence - Abstract
The Absorb bioresorbable scaffold (BRS), the most studied device among all BRS, suffered a major setback following the negative results of the ABSORB trials. However, approximately 34 BRSs from 22 companies are currently under development. The potential device-specific factors related to the increased event rate in Absorb were: 1) weak mechanical properties, 2) larger strut thickness (less embedment and larger protrusion) and width (larger footprint) predisposing to underexpansion/protrusion of struts, eventually resulting in increased thrombogenicity, and 3) longer bioresorption time combined with failure of encapsulation of struts before the dismantling process ensues. Given the diversity of bioresorbable materials (even amongst PLLA), and the different mechanical properties and bioresorption profiles of each new BRS, one could expect considerable difference in early and late clinical outcomes. As a matter of fact, data from first-in-man (FIM) and pivotal trials have demonstrated variable clinical results. Indeed, early clinical evidence from FIM trials does not support a class effect. However, the absence of a comparator precludes us from drawing definitive conclusions. Further clinical evidence should confirm the absence (or presence) of a class effect.
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- 2019
33. Serial Optical Coherence Tomography at Baseline, 7 Days, and 1, 3, 6 and 12 Months After Bioresorbable Scaffold Implantation in a Growing Porcine Model
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Seppo Ylä-Herttuala, Ply Chichareon, Hidenori Komiyama, Jarkko P. Hytönen, Rodrigo Modolo, Yosuke Miyazaki, Jouni Taavitsainen, Jan J. Piek, Yoshinobu Onuma, Kuniaki Takahashi, Andreas Baumbach, Erhan Tenekecioglu, Anthony Mathur, Joanna J. Wykrzykowska, Yohei Sotomi, Taku Asano, John Martin, Yuki Katagiri, Patrick W. Serruys, Norihiro Kogame, ACS - Heart failure & arrhythmias, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Graduate School, and Cardiology
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Time Factors ,Swine ,medicine.medical_treatment ,Area change ,030204 cardiovascular system & hematology ,Coronary Angiography ,Prosthesis Design ,Coronary artery disease ,Pediatrics ,Percutaneous coronary intervention ,03 medical and health sciences ,0302 clinical medicine ,Optical coherence tomography ,Absorbable Implants ,Stent ,medicine ,Animals ,030212 general & internal medicine ,medicine.diagnostic_test ,business.industry ,General Medicine ,medicine.disease ,Coronary Vessels ,Coronary arteries ,medicine.anatomical_structure ,Models, Animal ,Angiography ,Stents ,Cardiology and Cardiovascular Medicine ,Nuclear medicine ,business ,Tomography, Optical Coherence ,Bioresorbable scaffold - Abstract
Background: Little is known about serial changes in lumen and device dimensions after bioresorbable scaffold implantation in a growing animal model. Methods and Results: ABSORB (n=14) or bare metal stents (ICROS amg [Abbott Vascular, Santa Clara, CA, USA], Winsen-Luhe, Germany; n=15) were implanted in the coronary arteries of domestic swine (a hybrid of Finnish-Norwegian Landrace swine) weighing 30–35kg. Angiography and optical coherence tomography (OCT) were performed immediately after implantation and repeated at 7 days, 1, 3, 6 and 12 months after the index procedure. One month after implantation, mean lumen area decreased relative to baseline in both groups (relative area change from baseline, −41.4±15.6% for ABSORB vs. −20.9±18.6% for ICROS) while mean device area decreased only in the ABSORB group (relative area change: −11.1±9.4% vs. +0.14±7.95%, respectively). At 12 months, mean lumen area increased relative to baseline in both groups (relative area change from baseline, +55.6±22.4% vs. +32.3±83.6%, respectively) in accordance with the swine growth weighing up to 260–300kg. Mean device area in the ICROS group remained stable whereas that in the ABSORB group began to increase between 3 and 6 months along with the vessel growth (relative area change: +107.8±25.7% vs. +0.14±7.95%). Conclusions: In the growing porcine model, ABSORB was associated with greater extent of recoil 1 month after implantation compared with ICROS but demonstrated substantial adaptability to vessel growth in late phase.
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- 2019
34. Mechanical properties and performances of contemporary drug-eluting stent: focus on the metallic backbone
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Neville Kukreja, Rodrigo Modolo, Chun-Chin Chang, Erhan Tenekecioglu, Ply Chichareon, Jan J. Piek, Taku Asano, Yuki Katagiri, Patrick W. Serruys, Kuniaki Takahashi, Joanna J. Wykrzykowska, Norihiro Kogame, Yoshinobu Onuma, Mariusz Tomaniak, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, and Cardiology
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medicine.medical_specialty ,Standard of care ,medicine.medical_treatment ,Biomedical Engineering ,Biocompatible Materials ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Materials Testing ,Humans ,Medicine ,cardiovascular diseases ,Mechanical Phenomena ,Clinical Trials as Topic ,Focus (computing) ,business.industry ,Percutaneous coronary intervention ,Drug-Eluting Stents ,General Medicine ,equipment and supplies ,Surgery ,surgical procedures, operative ,Metals ,Drug-eluting stent ,Conventional PCI ,business ,030217 neurology & neurosurgery ,Bioresorbable scaffold - Abstract
Introduction: Drug-eluting stents (DES) are still the standard of care in percutaneous coronary intervention (PCI) since the fall of bioresorbable scaffolds with respect to safety. The unbeatable advantage of a metallic stent when compared with a scaffold is a stronger mechanical property and more sustainable vascular support. Recent development of contemporary metallic stent has focused on the reduction of strut thickness. However, there will always be a trade-off between improvement in deliverability, flexibility, and radial strength. Areas covered: This review aims to discuss the designs of metallic stent platform and mechanical properties as well as mechanical performance of contemporary DES from bench studies and clinical trials. Expert opinion: Mechanical properties of stents affect short- and long-term clinical outcomes. Ultrathin-strut DES have become popular and clinical trials have shown impressive results. Thinner struts may improve device flexibility and deliverability but the radial strength and longitudinal integrity might have been compromised as well. Ultrathin-strut cobalt chromium or platinum chromium DES will become standard of care in PCI practice in the near future. Information on the stent design, stent material and mechanical properties of the stent are essential for a rational selection of the appropriate stent in selected lesions and patients.
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- 2019
35. Angiography-Derived Fractional Flow Reserve in the SYNTAX II Trial
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Yoshinobu Onuma, Rodrigo Modolo, Adrian P. Banning, Vasim Farooq, Nicolas M. Van Mieghem, Erhan Tenekecioglu, Jan J. Piek, Javier Escaned, Neal G. Uren, Ply Chichareon, Norihiro Kogame, Hans Jonker, Clare Appleby, Chun Chin Chang, Carlos Collet, Johan H. C. Reiber, Taku Asano, Yuki Katagiri, Patrick W. Serruys, Azfar Zaman, Javier Zueco, and Kuniaki Takahashi
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medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Area under the curve ,Value (computer science) ,Percutaneous coronary intervention ,Fractional flow reserve ,Disease ,030204 cardiovascular system & hematology ,Cardiac surgery ,03 medical and health sciences ,0302 clinical medicine ,Angiography ,medicine ,In patient ,030212 general & internal medicine ,Radiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
Objectives The aims of the present study were to investigate the applicability of quantitative flow ratio (QFR) in patients with 3-vessel disease and to demonstrate the impact of functional SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score derived from QFR (fSSQFR) on clinical outcomes. Background The applicability of QFR in patients with 3-vessel disease and the feasibility of fSSQFR have not yet been investigated. Methods All lesions interrogated using instantaneous wave-free ratio and/or fractional flow reserve in the SYNTAX II trial were retrospectively screened and analyzed for QFR. The diagnostic performance of QFR was investigated using hybrid wire-derived pressure assessment (instantaneous wave-free ratio and fractional flow reserve), used in the trial as a reference. Patients with analyzable QFR in 3 vessels were stratified according to fSSQFR to evaluate its clinical prognostic value on the basis of 2-year patient-oriented composite endpoint. Results QFRs were analyzable in 71.0% of lesions (836 lesions). The diagnostic performance of QFR to predict binary wire-based ischemia was substantial (area under the curve 0.81, accuracy 73.8%), with a positive predictive value of 85.9%. Independent predictors of diagnostic discordance were lesions in side branches, involvement of bifurcation or trifurcation, and small vessel. According to the 2-year patient-oriented composite endpoint, fSSQFR reclassified 26.1% of the patients (36 of 138) in the high- to intermediate-risk group into the low-risk group appropriately (net reclassification improvement 0.32; p Conclusions QFR demonstrated substantial applicability in patients with 3-vessel disease. The fSSQFR has the potential to further refine prognostic risk estimation compared with the classic anatomic SYNTAX score.
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- 2019
36. Ascertainment of Silent Myocardial Infarction in Patients Undergoing Percutaneous Coronary Intervention (from the GLOBAL LEADERS Trial)
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Pascal Vranckx, Yoshinobu Onuma, Olivier F. Bertrand, Tian Hai Koh, Robert-Jan van Geuns, Rodrigo Modolo, Osama Ibrahim Ibrahim Soliman, Rui Cruz Ferreira, Chun Chin Chang, Aris Moschovitis, Marco Valgimigli, Sing-Chien Yap, Stephen P. Hoole, Hidenori Komiyama, Christian W. Hamm, Amanda G. M. R. Sousa, Azfar Zaman, Philippe Gabriel Steg, Patrick W. Serruys, Tommaso Gori, Peter Jüni, Ernest Spitzer, Kuniaki Takahashi, Bernhard Frey, Stephan Windecker, Mariusz Tomaniak, Ply Chichareon, Norihiro Kogame, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, and Cardiology
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Male ,Ticagrelor ,Internationality ,medicine.medical_treatment ,Myocardial Infarction ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Coronary Angiography ,HSM CAR ,Aspirin / therapeutic use ,law.invention ,Electrocardiography ,0302 clinical medicine ,Randomized controlled trial ,law ,Silent Myocardial Infarction ,Clinical endpoint ,Electrocardiography / methods ,Prospective Studies ,030212 general & internal medicine ,Myocardial infarction ,610 Medicine & health ,education.field_of_study ,Myocardial Infarction / diagnostic imaging ,Drug-Eluting Stents ,Middle Aged ,Prognosis ,Treatment Outcome ,Cardiology ,Drug Therapy, Combination ,Female ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Population ,Myocardial Infarction / mortality ,Risk Assessment ,Statistics, Nonparametric ,03 medical and health sciences ,Percutaneous Coronary Intervention ,Multicenter trial ,Internal medicine ,medicine ,Humans ,Percutaneous Coronary Intervention / mortality ,cardiovascular diseases ,Ticagrelor / therapeutic use ,education ,Coronary Angiography / methods ,Aged ,Asymptomatic Diseases / mortality ,Analysis of Variance ,Aspirin ,business.industry ,Percutaneous coronary intervention ,medicine.disease ,Survival Analysis ,Percutaneous Coronary Intervention / methods ,Asymptomatic Diseases ,Conventional PCI ,Myocardial Infarction / therapy ,business - Abstract
Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial. info:eu-repo/semantics/publishedVersion
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- 2019
37. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI
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Scot Garg, Rodrigo Modolo, Patrick W. Serruys, Robbert J. de Winter, Robert Zweiker, Mariusz Tomaniak, Michael Magro, Norihiro Kogame, Jan G.P. Tijssen, Marco Valgimigli, Christian W. Hamm, Kuniaki Takahashi, Philippe Gabriel Steg, Saqib Chowdhary, Pascal Vranckx, Hans-Peter Stoll, Didier Carrié, Paul Jau Lueng Ong, Ingo Eitel, Ply Chichareon, Joanna J. Wykrzykowska, Chun Chin Chang, Michael Mundt Ottesen, Yoshinobu Onuma, Stephan Windecker, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Microcirculation
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Male ,Risk ,medicine.medical_specialty ,Ticagrelor ,medicine.medical_treatment ,Myocardial Infarction ,Hemorrhage ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,Myocardial Revascularization ,Humans ,030212 general & internal medicine ,Prospective Studies ,cardiovascular diseases ,610 Medicine & health ,Aged ,Proportional Hazards Models ,Aspirin ,business.industry ,Hazard ratio ,Percutaneous coronary intervention ,Thrombosis ,Middle Aged ,Stroke ,Regimen ,Treatment Outcome ,Drug-eluting stent ,Conventional PCI ,Female ,Patient Safety ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Background: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse. Objectives: This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI. Methods: The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding. Results: Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754). Conclusions: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).
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- 2019
38. The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial
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Rodrigo Modolo, Robin P. Kraak, Martina Nassif, Deborah N. Kalkman, Sjoerd H. Hofma, Ply Chichareon, E. Karin Arkenbout, Jan J. Piek, José P.S. Henriques, Ruben Y.G. Tijssen, Jan G.P. Tijssen, Laura S.M. Kerkmeijer, Yoshinobu Onuma, Norihiro Kogame, Carlos Collet, Robbert J. de Winter, Yohei Sotomi, Yuki Katagiri, Marcel A.M. Beijk, Auke P.J.D. Weevers, Joanna J. Wykrzykowska, Taku Asano, Patrick W. Serruys, Kuniaki Takahashi, René J. van der Schaaf, ACS - Heart failure & arrhythmias, Graduate School, Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Diabetes & metabolism, AGEM - Endocrinology, metabolism and nutrition, ACS - Amsterdam Cardiovascular Sciences, and Division 4
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Coronary angiography ,Device sizing ,Time Factors ,Target lesion revascularization ,Everolimus eluting stent ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary Angiography ,Prosthesis Design ,Lesion ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Predictive Value of Tests ,Risk Factors ,Quantitative coronary angiography ,Absorbable Implants ,Scaffold thrombosis ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Everolimus ,Bioresorbable vascular scaffold ,Netherlands ,Original Paper ,medicine.diagnostic_test ,business.industry ,Coronary Thrombosis ,Significant difference ,Cardiovascular Agents ,Drug-Eluting Stents ,medicine.disease ,Thrombosis ,Coronary Vessels ,Treatment Outcome ,Angiography ,Bioresorbable scaffolds ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Nuclear medicine ,business ,Bioresorbable scaffold - Abstract
Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices. Electronic supplementary material The online version of this article (10.1007/s10554-019-01576-y) contains supplementary material, which is available to authorized users.
- Published
- 2019
39. Utility of the dual antiplatelet therapy score to guide antiplatelet therapy: A systematic review and meta-analysis
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Nino Mihatov, Changyu Shen, Robert W. Yeh, Ply Chichareon, Gabriel Steg, Dean J. Kereiakes, Patrick W. Serruys, Eric A. Secemsky, Graduate School, ACS - Atherosclerosis & ischemic syndromes, and ACS - Microcirculation
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medicine.medical_specialty ,animal structures ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,risk score ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,P2Y12 ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Myocardial infarction ,Framingham Risk Score ,Clinical events ,business.industry ,Dual Anti-Platelet Therapy ,percutaneous coronary intervention ,Percutaneous coronary intervention ,Drug-Eluting Stents ,General Medicine ,medicine.disease ,bleeding ,dual antiplatelet therapy ,Treatment Outcome ,myocardial infarction ,Relative risk ,Meta-analysis ,Drug Therapy, Combination ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors - Abstract
Background The dual antiplatelet therapy (DAPT) score, one of the first prediction tools to attempt to uncouple bleeding and ischemic risk following percutaneous coronary intervention, can help guide antiplatelet duration after coronary intervention. Evaluating the generalizability of the score is important to understand its utility in clinical practice. Methods We conducted a systematic review and meta-analysis of studies that validated the DAPT score. A random effect meta-analysis was performed of ischemic and bleeding risk based on DAPT score. A secondary analysis assessed the risk of longer versus shorter P2Y12 inhibitor duration on ischemic and bleeding risk in randomized controlled trials of DAPT duration. Results We identified 10 patient cohorts involving 88,563 patients. Compared with a low DAPT score, a high DAPT score was associated with increased ischemic risk (RR: 1.62, 95% CI: 1.41-1.87) and reduced bleeding risk (RR: 0.80, 95% CI: 0.70-0.92). In three randomized trials of DAPT duration that contained information on the DAPT score, the relative risk of net adverse clinical events (combined ischemic and bleeding events) with longer duration of DAPT was 1.56 (95% CI: 0.77-3.19) for low DAPT score patients, and 0.86 (95% CI: 0.61-1.21) for high DAPT score patients (pinteraction = .14). Conclusions In this large meta-analysis, the DAPT score consistently stratified bleeding and ischemic risk in opposing directions across several different study populations. More evaluation is needed to understand if the effect of longer DAPT duration on NACE is modified by the DAPT score in current practice.
- Published
- 2021
40. Predicting 2-year all-cause mortality after contemporary PCI: Updating the logistic clinical SYNTAX score
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Ewout W. Steyerberg, Bo Xu, Jan J. Piek, Peter Jüni, Kuniaki Takahashi, Chun-Chin Chang, Yuejin Yang, David van Klaveren, Ying Song, Paul Jau Lueng Ong, Ply Chichareon, Stephan Windecker, Marco Valgimigli, Joanna J. Wykrzykowska, Shubin Qiao, Robert-Jan van Geuns, Changdong Guan, Aleksander Zurakowski, Gabriel Steg, Patrick W. Serruys, Christian W. Hamm, Scot Garg, Yoshinobu Onuma, Manel Sabaté, Mariusz Tomaniak, Norihiro Kogame, Pascal Vranckx, Jinqing Yuan, Lihua Xie, Rodrigo Modolo, Public Health, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Microcirculation
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medicine.medical_specialty ,medicine.medical_treatment ,risk stratification ,030204 cardiovascular system & hematology ,risk score ,Risk Assessment ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,610 Medicine & health ,Stroke ,Framingham Risk Score ,business.industry ,percutaneous coronary intervention ,Percutaneous coronary intervention ,General Medicine ,medicine.disease ,Missing data ,Treatment Outcome ,Cohort ,Conventional PCI ,Akaike information criterion ,Cardiology and Cardiovascular Medicine ,business ,coronary artery disease - Abstract
AIMS We aimed to update the logistic clinical SYNTAX score to predict 2��year all-cause mortality after contemporary percutaneous coronary intervention (PCI). METHODS AND RESULTS We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2��year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2��year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population. CONCLUSIONS The new model of the logistic clinical SYNTAX score better predicts 2��year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.
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- 2021
41. Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial
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Robert-Jan van Geuns, Didier Carrié, Norihiro Kogame, Mariusz Tomaniak, Adel Aminian, Philippe Gabriel Steg, Piotr P. Buszman, Ton Slagboom, Aleksander Zurakowski, Scot Garg, Masafumi Ono, Rodrigo Modolo, Patrick W. Serruys, Rutao Wang, Ply Chichareon, Chun Chin Chang, Kuniaki Takahashi, Paweł Buszman, Christoph Naber, Hironori Hara, Yoshinobu Onuma, Hideyuki Kawashima, Chao Gao, Christian W. Hamm, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, and Cardiology
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,Myocardial Infarction ,Hemorrhage ,Femoral artery ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Internal medicine ,medicine.artery ,Clinical endpoint ,Medicine ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Radial artery ,education ,Aged ,education.field_of_study ,business.industry ,Hazard ratio ,Percutaneous coronary intervention ,Middle Aged ,medicine.disease ,Confidence interval ,Femoral Artery ,Stroke ,Radial Artery ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. Methods: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. Results: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. Conclusions: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.
- Published
- 2021
42. UPDATED WILKINS SCORE BETTER PREDICTS PROCEDURAL SUCCESS OF PERCUTANEOUS BALLOON MITRAL VALVULOPLASTY IN RHEUMATIC MITRAL STENOSIS
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Ply Chichareon, Thanapon Nilmoje, Saranyou Suwanugsorn, Noppadol Chamnarnphol, Treechada Wisaratapong, Sirichai Cheewatanakornkul, Sunti Limumpornpetch, Metus Thungthienthong, Watchara Lohawijarn, and Woravut Jintapakorn
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Cardiology and Cardiovascular Medicine - Published
- 2022
43. Low Body Weight Increases the Risk of Ischemic Stroke and Major Bleeding in Atrial Fibrillation:The COOL-AF Registry
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Ply Chichareon, Sakaorat Kornbongkotmas, Gregory Y.H. Lip, Chulalak Komoltri, Rungroj Krittayaphong, and Ahthit Yindeengam
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medicine.medical_specialty ,medicine.drug_class ,lcsh:Medicine ,COOL-AF Registry ,030204 cardiovascular system & hematology ,Article ,03 medical and health sciences ,0302 clinical medicine ,non-valvular atrial fibrillation ,Internal medicine ,parasitic diseases ,ischemic stroke ,Medicine ,Medical history ,030212 general & internal medicine ,reproductive and urinary physiology ,Intracerebral hemorrhage ,business.industry ,lcsh:R ,Hazard ratio ,Anticoagulant ,Atrial fibrillation ,General Medicine ,medicine.disease ,female genital diseases and pregnancy complications ,low body weight ,Thai patients ,major bleeding ,Ischemic stroke ,population characteristics ,business ,human activities ,Major bleeding ,Cohort study - Abstract
We aimed to determine if low body weight (LBW) status (<, 50 kg) is independently associated with increased risk of ischemic stroke and bleeding in Thai patients with non-valvular atrial fibrillation (NVAF). (1) Background: It has been unclear whether LBW influence clinical outcome of patients with NVAF. (2) Methods: This prospective multicenter cohort study included patients enrolled in the COOL-AF Registry. The following data were collected: demographic data, medical history, risk factors and comorbid conditions, laboratory and investigation data, and medications. Follow-up data were collected every 6 months. Clinical events during follow-up were confirmed by the adjudication committee. (3) Results: A total of 3367 patients were enrolled. The mean age was 67.2 ±, 11.2 years. LBW was present in 338 patients (11.3%). Anticoagulant and antiplatelet was prescribed in 75.3% and 26.2% of patients, respectively. Ischemic stroke, major bleeding, intracerebral hemorrhage (ICH), and death occurred during follow-up in 2.9%, 4.4%, 1.4%, and 7.7% of patients, respectively, during 25.7 months follow-up. LBW was an independent predictor of ischemic stroke, major bleeding, ICH, and death, with a hazard ratio of 2.40, 1.79, 2.37, and 2.65, respectively. (4) Conclusions: LBW was independently associated with increased risk of adverse outcomes in Thai patients with NVAF. This should be carefully considered when balancing the risks and benefits of stroke prevention among patients with different body weights.
- Published
- 2020
44. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial
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Hideyuki Kawashima, Scot Garg, Chao Gao, Hironori Hara, Nick Curzen, Dominika Klimczak-Tomaniak, Christian W. Hamm, Dominick J. Angiolillo, Marco Valgimigli, Pascal Vranckx, Richard Anderson, Norihiro Kogame, Davide Capodanno, Masafumi Ono, Rutao Wang, Ply Chichareon, Rodrigo Modolo, Michael Haude, Mariusz Tomaniak, Yoshinobu Onuma, Janusz Kochman, Robert F. Storey, Tessa Rademaker-Havinga, Tommaso Gori, Stephan Windecker, Gilles Montalescot, Patrick W. Serruys, Kuniaki Takahashi, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Medical University of Warsaw - Poland, Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), University of Campinas [Campinas] (UNICAMP), Xijing Hospital, Radboud university [Nijmegen], University Medical Center [Mainz], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University of Catania [Italy], University of Sheffield [Sheffield], Bern University Hospital [Berne] (Inselspital), National University of Ireland [Galway] (NUI Galway), Imperial College London, National Heart and Lung Institute [London] (NHLI), Royal Brompton and Harefield NHS Foundation Trust-Imperial College London, University of Wales, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Graduate School, Cardiology, ACS - Heart failure & arrhythmias, University of Zurich, and Serruys, Patrick W
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Male ,Acute coronary syndrome ,medicine.medical_specialty ,Ticagrelor ,Impaired renal function ,medicine.medical_treatment ,Aspirin-free antiplatelet strategies ,[SDV]Life Sciences [q-bio] ,610 Medicine & health ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,Percutaneous coronary intervention ,Coronary artery disease ,03 medical and health sciences ,Chronic kidney disease ,DAPT ,0302 clinical medicine ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Renal Insufficiency ,Acute Coronary Syndrome ,Aged ,business.industry ,Dual Anti-Platelet Therapy ,Hazard ratio ,Drug-Eluting Stents ,General Medicine ,Middle Aged ,medicine.disease ,3. Good health ,Treatment Outcome ,Conventional PCI ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug ,Glomerular Filtration Rate - Abstract
Background: Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF. Methods: A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m 2). Results: At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35–1.98, p adj = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61–1.11, p = 0.192, p int = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71–1.71, p = 0.656, p int = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (p int = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (p int = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF. Conclusions: IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy. Clinical trial registration: The trial has been registered with ClinicalTrials.gov, number NCT01813435. Graphic abstract: [Figure not available: see fulltext.].
- Published
- 2020
45. The impact of pre-procedure heart rate on adverse clinical outcomes in patients undergoing percutaneous coronary intervention: Results from a 2-year follow-up of the GLOBAL LEADERS trial
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Masafumi Ono, Roberto Botelho, Chao Gao, Pascal Vranckx, Christian W. Hamm, Ply Chichareon, Volker Schächinger, Imre Ungi, Gincho Tonev, Kuniaki Takahashi, Eric Eeckhout, Stephan Windecker, Robert-Jan van Geuns, Hironori Hara, Rutao Wang, Hideyuki Kawashima, Scot Garg, Rodrigo Modolo, Patrick W. Serruys, Yoshinobu Onuma, Mariusz Tomaniak, Norihiro Kogame, Peter Jüni, ACS - Heart failure & arrhythmias, Graduate School, Cardiology, ACS - Atherosclerosis & ischemic syndromes, and ACS - Microcirculation
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0301 basic medicine ,medicine.medical_specialty ,medicine.medical_treatment ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,education ,Myocardial Infarction ,Hemorrhage ,030204 cardiovascular system & hematology ,Coronary artery disease ,Percutaneous coronary intervention ,03 medical and health sciences ,0302 clinical medicine ,Heart Rate ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Myocardial infarction ,Mortality ,610 Medicine & health ,Pre-procedure heart rate ,Proportional hazards model ,business.industry ,Hazard ratio ,medicine.disease ,Confidence interval ,Treatment Outcome ,030104 developmental biology ,Conventional PCI ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies ,Predictor - Abstract
Contains fulltext : 225405.pdf (Publisher’s version ) (Open Access) BACKGROUND AND AIMS: The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the "all-comers" GLOBAL LEADERS trial. METHODS AND RESULTS: The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p 67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies. CONCLUSIONS: Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the "all-comer" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.
- Published
- 2020
46. The SYNTAX score on its way out or … towards artificial intelligence: part II
- Author
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Patrick W. Serruys, Ply Chichareon, Rodrigo Modolo, David M. Leaman, Johan H.C. Reiber, Håkan Emanuelsson, Carlo Di Mario, Nico H.J. Pijls, Marie-Angèle Morel, Marco Valgimigli, Vasim Farooq, David van Klaveren, Davide Capodanno, Daniele Andreini, Christos V. Bourantas, Justin Davies, Adrian P. Banning, Javier Escaned, Jan J. Piek, Mauro Echavarría-Pinto, Charles Anthony Taylor, Brian Thomsen, Carlos Collet, Giulio Pompilio, Antonio L. Bartorelli, Ben Glocker, Ovidiu Dressler, Gregg W. Stone, Yoshinobu Onuma, University of Zurich, Serruys, Patrick W, Public Health, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and ACS - Heart failure & arrhythmias
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Artificial Intelligence ,Humans ,610 Medicine & health ,Coronary Artery Disease ,Cardiology and Cardiovascular Medicine ,Risk Assessment ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine - Abstract
How did a percutaneous coronary intervention/coronary artery bypass grafting randomised trial generate the anatomic syntax score?
- Published
- 2020
47. The SYNTAX score on its way out or ... towards artificial intelligence: part I
- Author
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Adrian P. Banning, Vasim Farooq, Mauro Echavarria-Pinto, Giulio Pompilio, Javier Escaned, Marco Valgimigli, Jan J. Piek, Carlos Collet, Ben Glocker, Ovidiu Dressler, Justin E. Davies, Christos V Bourantas, Rodrigo Modolo, Charles A. Taylor, Yoshinobu Onuma, David M. Leaman, Davide Capodanno, Patrick W. Serruys, Carlo Di Mario, Antonio L. Bartorelli, Gregg W. Stone, Marie-Angèle Morel, David van Klaveren, Daniele Andreini, Johan H. C. Reiber, Nico H.J. Pijls, Ply Chichareon, Brian Thomsen, Håkan Emanuelsson, University of Zurich, Serruys, Patrick W, Public Health, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and ACS - Heart failure & arrhythmias
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Syntax (programming languages) ,business.industry ,MEDLINE ,610 Medicine & health ,Coronary Artery Disease ,computer.software_genre ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,Artificial Intelligence ,Medicine ,Artificial intelligence ,Cardiology and Cardiovascular Medicine ,business ,computer ,Natural language processing - Published
- 2020
48. Impact of non-respect of SYNTAX score II recommendation for surgery in patients with left main coronary artery disease treated by percutaneous coronary intervention: an EXCEL substudy
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Ply Chichareon, Yiran Zhang, Patrick W. Serruys, Ovidiu Dressler, Rodrigo Modolo, Joseph F. Sabik, Yoshinobu Onuma, Gregg W. Stone, David van Klaveren, Arie Pieter Kappetein, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and Cardiology
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Left main coronary artery disease ,medicine.medical_treatment ,Population ,Coronary artery bypass grafting ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Revascularization ,Cohort Studies ,03 medical and health sciences ,Coronary artery bypass surgery ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,In patient ,Prospective Studies ,030212 general & internal medicine ,cardiovascular diseases ,Coronary Artery Bypass ,education ,Drug-eluting stents ,education.field_of_study ,business.industry ,Percutaneous coronary intervention ,General Medicine ,SYNTAX score ,Treatment Outcome ,surgical procedures, operative ,Cohort ,Conventional PCI ,Cardiology ,Surgery ,Cardiology and Cardiovascular Medicine ,business - Abstract
OBJECTIVES The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease. METHODS The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years. RESULTS SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51–3.24), P = 0.003; slope 0.67 (0.61–0.74), P CONCLUSIONS In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality.
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- 2020
49. Association of Sex with Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial
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Norihiro Kogame, Ply Chichareon, Hidenori Komiyama, Laura S.M. Kerkmeijer, Peter Barlis, Luc Maillard, Suneel Talwar, Kuniaki Takahashi, Yoshinobu Onuma, Roxana Mehran, Chun-Chin Chang, Philippe Gabriel Steg, Joanna J. Wykrzykowska, Antonio Colombo, Rodrigo Modolo, Mariusz Tomaniak, Patrick W. Serruys, Tiziano Moccetti, Marco Valgimigli, Stephan Windecker, Peter Jüni, Christian W. Hamm, Jan J. Piek, Scot Garg, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, Cardiology, University of Zurich, and Serruys, Patrick W
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Male ,Ticagrelor ,medicine.medical_treatment ,Myocardial Infarction ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Myocardial Revascularization ,Secondary Prevention ,Outpatient clinic ,030212 general & internal medicine ,610 Medicine & health ,Stroke ,Original Investigation ,Dual Anti-Platelet Therapy ,Hazard ratio ,Drug-Eluting Stents ,Middle Aged ,Hemorrhagic Stroke ,Female ,Cardiology and Cardiovascular Medicine ,medicine.drug ,medicine.medical_specialty ,Hemorrhage ,Lower risk ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,03 medical and health sciences ,Percutaneous Coronary Intervention ,Sex Factors ,Internal medicine ,medicine ,Humans ,Mortality ,Aged ,Ischemic Stroke ,Proportional Hazards Models ,Aspirin ,business.industry ,Percutaneous coronary intervention ,Thrombosis ,medicine.disease ,Conventional PCI ,business ,Platelet Aggregation Inhibitors - Abstract
IMPORTANCE: Women experience worse ischemic and bleeding outcomes after percutaneous coronary intervention (PCI). OBJECTIVES: To assess the association of sex with patient outcomes at 2 years after contemporary PCI and with the efficacy and safety of 2 antiplatelet strategies. DESIGN, SETTING, AND PARTICIPANTS: This study is a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating 2 strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15 991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Data were analyzed between January 1, 2019, and March 31, 2019. INTERVENTIONS: Eligible patients were randomized to either the experimental or reference antiplatelet strategy. Experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy. MAIN OUTCOMES AND MEASURES: The primary efficacy end point was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety end point was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Of the 15 968 patients included in this study, 3714 (23.3%) were women. The risk of the primary end point at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% CI, 0.83-1.20). Compared with men, women had higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the 2 antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98) but not in women (HR, 1.23; 95% CI, 0.80-1.89; P for interaction = .045). CONCLUSIONS AND RELEVANCE: Compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI. The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01813435
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- 2020
50. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial
- Author
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Hideyuki Kawashima, Marco Valgimigli, Masafumi Ono, Stephan Windecker, Yoshinobu Onuma, Ibrahim Akin, Joanna J. Wykrzykowska, Mariusz Tomaniak, René Koning, Chao Gao, Rodrigo Modolo, James Cotton, Simon J Walsh, Christian W. Hamm, Ply Chichareon, Kuniaki Takahashi, Norihiro Kogame, Scot Garg, Harry Suryapranata, Hironori Hara, Pedro Canas da Silva, Philippe Gabriel Steg, Patrick W. Serruys, Jan J. Piek, Benno J. Rensing, Pascal Vranckx, Rutao Wang, Peter Jüni, Robert F. Storey, Cardiology, Ono, Masafumi, Chichareon, Ply, Tomaniak, Mariusz, Kawashima, Hideyuki, Takahashi, Kuniaki, Kogame, Norihiro, Modolo, Rodrigo, Hara, Hironori, Gao, Chao, Wang, Rutao, Walsh, Simon, Suryapranata, Harry, da Silva, Pedro Canas, Cotton, James, Koning, Rene, Akin, Ibrahim, Rensing, Benno J. W. M., Garg, Scot, Wykrzykowska, Joanna J., Piek, Jan J., Juni, Peter, Hamm, Christian, Steg, Philippe Gabriel, Valgimigli, Marco, Windecker, Stephan, Storey, Robert F., Onuma, Yoshinobu, VRANCKX, Pascal, Serruys, Patrick W., University of Zurich, Serruys, Patrick W, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and ACS - Heart failure & arrhythmias
- Subjects
Male ,Ticagrelor ,medicine.medical_specialty ,Acute coronary syndrome ,Time Factors ,medicine.medical_treatment ,Population ,Myocardial Infarction ,610 Medicine & health ,Coronary Artery Disease ,11171 Cardiocentro Ticino ,2705 Cardiology and Cardiovascular Medicine ,law.invention ,Percutaneous coronary intervention ,Coronary artery disease ,Randomized controlled trial ,law ,Internal medicine ,Clinical endpoint ,Humans ,Medicine ,Prospective Studies ,education ,Body mass index ,Aged ,Original Paper ,education.field_of_study ,Ticagrelor monotherapy ,Aspirin ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Treatment Outcome ,Dual antiplatelet therapy ,Cardiology ,Platelet aggregation inhibitor ,Drug Therapy, Combination ,Female ,Drug-eluting stent ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Background: The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI). Methods and results: This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (adjusted HR 1.24, 95% CI 1.02–1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (pinteraction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m2 (HR 0.69, 95% CI 0.51–0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (adjusted HR 1.24, 95% CI 1.02–1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (pinteraction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m2 (HR 0.69, 95% CI 0.51–0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (adjusted HR 1.24, 95% CI 1.02–1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (pinteraction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m2 (HR 0.69, 95% CI 0.51–0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (adjusted HR 1.24, 95% CI 1.02–1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (pinteraction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m2 (HR 0.69, 95% CI 0.51–0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. Conclusions: Overall, BMI did not influence the treatment effect seen with ticagrelor monotherapy; however, a beneficial effect of ticagrelor monotherapy was seen in ACS patients with BMI < 27 kg/m2. Trial registration: The trial has been registered with ClinicalTrials.gov, Number NCT01813435. Graphic abstract: [Figure not available: see fulltext.].
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- 2020
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