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Abstract Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach. Clinical Trial Registration: NCT02748226.

Abstract Background The impact of rosuvastatin versus atorvastatin on new-onset diabetes mellitus (NODM) among patients treated with high-intensity statin therapy for coronary artery disease (CAD) remains to be clarified. This study aimed to evaluate the risk of NODM in patients with CAD treated with rosuvastatin compared to atorvastatin in the randomized LODESTAR trial. Methods In the LODESTAR trial, patients with CAD were randomly assigned to receive either rosuvastatin or atorvastatin using a 2-by-2 factorial randomization. In this post-hoc analysis, the 3-year incidence of NODM was compared between rosuvastatin and atorvastatin treatment in the as-treated population with high-intensity statin therapy as the principal population of interest. Results Among 2932 patients without diabetes mellitus at baseline, 2377 were included in the as-treated population analysis. In the as-treated population with high-intensity statin therapy, the incidence of NODM was not significantly different between the rosuvastatin and atorvastatin groups (11.4% [106/948] versus 8.8% [73/856], hazard ratio [HR] = 1.32, 95% confidence interval [CI] = 0.98 to 1.77, P = 0.071). When the risk of NODM with rosuvastatin versus atorvastatin was assessed according to the achieved low-density lipoprotein cholesterol (LDL-C) level, the risk of NODM began to increase at a LDL-C level below 70 mg/dL. The incidence of NODM was significantly greater in the rosuvastatin group than it was in the atorvastatin group when the achieved LDL-C level was

Background After coronary stent implantation, prolonged dual antiplatelet therapy (DAPT) increases bleeding risk, requiring personalization of DAPT duration. The aim of this study was to develop and validate a machine learning model to predict optimal DAPT duration after contemporary drug‐eluting stent implantation in patients with coronary artery disease. Methods and Results The One‐Month DAPT, RESET (Real Safety and Efficacy of 3‐Month Dual Antiplatelet Therapy Following Endeavor Zotarolimus‐Eluting Stent Implantation), and IVUS‐XPL (Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesion) trials provided a derivation cohort (n=6568). Using the X‐learner approach, an individualized DAPT score was developed to determine the therapeutic benefit of abbreviated (1–6 months) versus standard (12‐month) DAPT using various predictors. The primary outcome was major bleeding; the secondary outcomes included 1‐year major adverse cardiac and cerebrovascular events and 1‐year net adverse clinical events. The risk reduction with abbreviated DAPT (3 months) in the individualized DAPT–determined higher predicted benefit group was validated in the TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus‐Eluting Stent for Acute Coronary Syndrome) trial (n=3056), which enrolled patients with acute coronary syndrome treated with ticagrelor. The validation cohort comprised 1527 abbreviated and 1529 standard DAPT cases. Major bleeding occurred in 25 (1.7%) and 45 (3.0%) patients in the abbreviated and standard DAPT groups, respectively. The individualized DAPT score identified 2582 (84.5%) participants who would benefit from abbreviated DAPT, which was significantly associated with a lower major bleeding risk (absolute risk difference [ARD], 1.26 [95% CI, 0.15–2.36]) and net adverse clinical events (ARD, 1.59 [95% CI, 0.07–3.10]) but not major adverse cardiac and cerebrovascular events (ARD, 0.63 [95% CI, −0.34 to 1.61]), compared with standard DAPT in the higher predicted benefit group. Abbreviated DAPT had no significant difference in clinical outcomes of major bleeding (ARD, 1.49 [95% CI, −1.74 to 4.72]), net adverse clinical events (ARD, 2.57 [95% CI, −1.85 to 6.99]), or major adverse cardiac and cerebrovascular events (ARD, 1.54 [95% CI, −1.26 to 4.34]), compared with standard DAPT in the individualized DAPT–determined lower predicted benefit group. Conclusions Machine learning using the X‐learner approach identifies patients with acute coronary syndrome who may benefit from abbreviated DAPT after drug‐eluting stent implantation, laying the groundwork for personalized antiplatelet therapy.

Abstract The clinical impact of different polymer technologies in newer-generation drug-eluting stents (DESs) for patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains poorly understood. We investigated the efficacy and safety of durable polymer DESs (DP-DESs) compared with biodegradable polymer DESs (BP-DESs). A total of 620 patients who underwent percutaneous coronary intervention with newer-generation DESs for AMI complicated by CS was divided into two groups based on polymer technology: the DP-DES group (n = 374) and the BP-DES group (n = 246). The primary outcome was target vessel failure (TVF) during a 12-month follow-up, defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Both the DP-DES and BP-DES groups exhibited low stent thrombosis rates (1.3% vs. 1.6%, p = 0.660). The risk of TVF did not significantly differ between the two groups (34.2% vs. 28.5%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69–1.29, p = 0.721). This finding remained consistent after adjustment with inverse probability of treatment weighting (28.1% vs. 25.1%, HR 0.98, 95% CI 0.77–1.27, p = 0.899). In AMI patients complicated by CS, the risk of a composite of cardiac death, myocardial infarction, or target vessel revascularization was not significantly different between those treated with DP-DESs and those treated with BP-DESs. Trial registration: RESCUE registry, https://clinicaltrials.gov/ct2/show/NCT02985008 , NCT02985008.

Abstract We aimed to evaluate sex differences in the effects of moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg plus ezetimibe) versus high-intensity statin (rosuvastatin 20 mg) monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD). This was a sex-specific subgroup analysis of the RACING trial that evaluated the interaction between sex and treatment strategies for the primary outcome (composite of cardiovascular death, major cardiovascular events, or nonfatal stroke at 3 years). Of 3780 patients in the RACING trial, 954 (25.2%) were women. Regardless of sex, the effect of moderate-intensity statin with ezetimibe combination therapy on primary outcome compared with high-intensity statin monotherapy was similar (hazard ratio [HR] 0.98 [0.63–1.52] in women; HR 0.90 [0.71–1.14] in men). The rate of discontinuation or dose reduction of study drugs due to intolerance was lower in the ezetimibe combination group than in the high-intensity statin monotherapy group in both women (4.5% vs. 8.6%, P = 0.014) and men (4.8% vs. 8.0%, P

Abstract Limited knowledge exists regarding the predictors of mortality after successful weaning of venoarterial extracorporeal membrane oxygenation (ECMO). We aimed to identify predictors of in-hospital mortality in patients with cardiogenic shock (CS) after successful weaning from ECMO. Data were obtained from a multicenter registry of CS. Successful ECMO weaning was defined as survival with minimal mean arterial pressure (> 65 mmHg) for > 24 h after ECMO removal. The primary outcome was in-hospital mortality after successful ECMO weaning. Among 1247 patients with CS, 485 received ECMO, and 262 were successfully weaned from ECMO. In-hospital mortality occurred in 48 patients (18.3%). Survivors at discharge differed significantly from non-survivors in age, cardiovascular comorbidities, cause of CS, left ventricular ejection fraction, and use of adjunctive therapy. Five independent predictors for in-hospital mortality were identified: use of continuous renal replacement therapy (odds ratio 5.429, 95% confidence interval [CI] 2.468–11.940; p

Background: Little is known about the association between seasonal variation and prognosis in patients with CS caused by AMI. Objectives: We investigated the 12-month clinical outcomes in patients treated with percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) according to season. Methods: A total of 695 patients undergoing PCI for AMI complicated by CS was enrolled from 12 centers in South Korea. The study patients were divided into four groups according to season in which the AMI with CS occurred (spring, n = 178 vs. summer, n = 155 vs. autumn, n = 182 vs. winter, n = 180). We compared major adverse cardiovascular events (MACEs; the composite of cardiac death, myocardial infarction, re-hospitalization due to heart failure, and any revascularization) between the four groups. Results: The risk of MACE during the 12 months after CS was similar in the four groups: spring, 68 patients, vs. summer, 69, vs. autumn, 73, vs. winter, 68 (p = 0.587). Multivariate Cox-regression analysis revealed no significant difference in 12-month MACE among groups compared to the spring group after inverse probability of treatment weighting adjustment (summer, HR 1.40, 95 % CI 0.98–1.99, p = 0.062; autumn, HR 1.26, 95 % CI 0.89–1.80, p = 0.193; winter, HR 1.18, 95 % CI 0.83–1.67, p = 0.356). The similarity of MACE between the four groups was consistent across a variety of subgroups. Conclusions: After adjusting for baseline differences, seasonal variation seems not to influence the mid-term risk of 12-month MACE in patients treated with PCI for AMI complicated by CS. Condensed abstract: Data are limited regarding the association between seasonal variation and prognosis in patients with cardiogenic shock (CS) caused by AMI. This study divided patients undergoing PCI for AMI complicated by CS into four groups based on the season of occurrence and found no significant differences in 12-month MACE between the groups after adjusting for bias and confounding factors. Multivariate analysis revealed consistent MACE similarity across subgroups. The study suggests that seasonal variation has no impact on the mid-term risk of 12-month MACE in patients with CS caused by AMI, after adjusting for baseline differences. Trial registration: ClinicalTrials.gov NCT02985008RESCUE (REtrospective and prospective observational Study to investigate Clinical oUtcomes and Efficacy of left ventricular assist device for Korean patients with cardiogenic shock), NCT02985008, Registered December 5, 2016 - retrospectively and prospectively. Irb information: This study was approved by the institutional review board of Samsung Medical Center (Reference number: 2016-03-130).

Background Clinical outcome of ischemic cardiogenic shock (CS) requiring extracorporeal membrane oxygenation is highly variable, necessitating appropriate assessment of prognosis. However, a systemic predictive model estimating the mortality of refractory ischemic CS is lacking. The PRECISE (Prediction of In‐Hospital Mortality for Patients With Refractory Ischemic Cardiogenic Shock Requiring Veno‐Arterial Extracorporeal Membrane Oxygenation Support) score was developed to predict the prognosis of refractory ischemic CS due to acute myocardial infarction. Methods and Results Data were obtained from the multicenter CS registry RESCUE (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock) that consists of 322 patients with acute myocardial infarction complicated by refractory ischemic CS requiring extracorporeal membrane oxygenation support. Fifteen parameters were selected to assess in‐hospital mortality. The developed model was validated internally and externally using an independent external cohort (n=138). Among 322 patients, 138 (42.9%) survived postdischarge. Fifteen predictors were included for model development: age, diastolic blood pressure, hypertension, chronic kidney disease, peak lactic acid, serum creatinine, lowest left ventricular ejection fraction, vasoactive inotropic score, shock to extracorporeal membrane oxygenation insertion time, extracorporeal cardiopulmonary resuscitation, use of intra‐aortic balloon pump, continuous renal replacement therapy, mechanical ventilator, successful coronary revascularization, and staged percutaneous coronary intervention. The PRECISE score yielded a high area under the receiver‐operating characteristic curve (0.894 [95% CI, 0.860–0.927]). External validation and calibration resulted in competent sensitivity (area under the receiver‐operating characteristic curve, 0.895 [95% CI, 0.853–0.930]). Conclusions The PRECISE score demonstrated high predictive performance and directly translates into the expected in‐hospital mortality rate. The PRECISE score may be used to support clinical decision‐making in ischemic CS (www.theprecisescore.com). Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02985008.

Abstract Regarding stent expansion indices, previous optical coherence tomography (OCT) studies have shown minimal stent area (MSA) to be most predictive of adverse events. We sought to evaluate the impact of various stent expansion and apposition indices by post-stent OCT on clinical outcomes and find OCT-defined optimal stent implantation criteria. A total of 1071 patients with 1123 native coronary artery lesions treated with new-generation drug-eluting stents with OCT guidance and final post-stent OCT analysis were included. Several stent expansion indices (MSA, MSA/average reference lumen area, MSA/distal reference lumen area, mean stent expansion, and stent expansion by linear model [stent volume/adaptive reference lumen volume]) were evaluated for their association with device-oriented clinical endpoints (DoCE) including cardiac death, target vessel-related myocardial infarction (MI) or stent thrombosis, and target lesion revascularization. MSA was negatively correlated with the risk of DoCE (hazard ratio [HR] 0.80 [0.68‒0.94]). However, stent expansion by linear model representing the overall volumetric stent expansion was associated with greater risk of DoCE (HR 1.02 [1.00‒1.04]). As categorical criteria, MSA

Summary: Background: The impact of titrated versus fixed intensity statin therapy in patients with coronary artery disease (CAD) and diabetes mellitus (DM) remains to be elucidated. Methods: This was a pre-specified analysis of patients with and without DM from the LODESTAR trial. Patients with CAD were randomly assigned to receive either a treat-to-target strategy with a target LDL-C level of 50–70 mg/dL or a high-intensity statin treatment. Primary outcome was the 3-year composite of all-cause death, myocardial infarction, stroke, or coronary revascularization. Secondary outcomes were safety endpoints. This trial is registered with ClinicalTrials.gov, NCT02579499. Findings: Between September 9, 2016 and November 27, 2019, 4400 patients with CAD were enrolled in the LODESTAR trial. The median age was 65 years (interquartile range, 59–73 years), 3172 (72%) were male, and 1468 (33%) had DM at baseline. There was no significant difference in the occurrence of the primary outcome between the treat-to-target group and high-intensity statin group among patients with DM (10.5% versus 11.1%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69–1.29, p = 0.70) and those without DM (6.9% versus 7.5%, HR 0.93, 95% CI 0.71–1.21, p = 0.58). Among patients without DM, there was a trend towards a lower risk of new-onset DM in the treat-to-target group (8.4% versus 10.4% in the high-intensity statin group, HR 0.79, 95% CI 0.62–1.01; p = 0.06). Interpretation: In patients with CAD, a treat-to-target LDL-C strategy of 50–70 mg/dL as the goal was comparable to high-intensity statin therapy in terms of 3-year clinical efficacy and safety outcomes regardless of the presence of DM. Funding: Sam Jin Pharmaceutical, Seoul, Korea and Chong Kun Dang Pharmaceutical, Seoul, Korea.

Background Despite the benefit of culprit‐only percutaneous coronary intervention (PCI) in the CULPRIT‐SHOCK (Culprit Lesion Only PCI Versus Multi‐vessel PCI in Cardiogenic Shock) trial, the optimal revascularization strategy for refractory cardiogenic shock (CS) requiring mechanical circulatory support devices remains controversial. This study aimed to compare clinical outcomes between the culprit‐only and immediate multivessel PCI strategies in patients with acute myocardial infarction complicated by CS who underwent venoarterial‐extracorporeal membrane oxygenation before revascularization. Methods and Results This study included patient‐pooled data from the RESCUE (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Devices for Korean Patients With Cardiogenic Shock) and SMC‐ECMO (Samsung Medical Center–Extracorporeal Membrane Oxygenation) registries. A total of 315 patients with acute myocardial infarction with multivessel disease who underwent venoarterial‐extracorporeal membrane oxygenation before revascularization attributable to refractory CS were included in this analysis. The study population was classified into culprit‐only versus immediate multivessel PCI according to nonculprit lesion treatment strategies. The primary end point was 30‐day mortality or renal‐replacement therapy, and the key secondary end point was 12‐month follow‐up mortality. Among the study population, 175 (55.6%) underwent culprit‐only PCI and 140 (44.4%) underwent immediate multivessel PCI. Compared with culprit‐only PCI, immediate multivessel PCI was associated with significantly lower risks of 30‐day mortality or renal‐replacement therapy (68.0% versus 54.3%; P=0.018) and all‐cause mortality during 12 months of follow‐up (59.5% versus 47.5%; hazard ratio [HR], 0.689 [95% CI, 0.506–0.939]; P=0.018) in patients with acute myocardial infarction and CS who underwent venoarterial‐extracorporeal membrane oxygenation before revascularization. These results were also consistent in the 99 pairs of propensity score–matched population (60.6% versus 43.6%; HR, 0.622 [95% CI, 0.420–0.922]; P=0.018). Conclusions Among patients with acute myocardial infarction with multivessel disease complicated by advanced CS requiring venoarterial‐extracorporeal membrane oxygenation before revascularization, immediate multivessel PCI was associated with lower incidences of 30‐day mortality or renal replacement therapy and 12‐month follow‐up mortality, compared with culprit‐only PCI. Registration Information clinicaltrials.gov. Identifier: NCT02985008.

Summary: Background: Moderate-intensity statin role with ezetimibe combination therapy following percutaneous coronary intervention (PCI) has not been thoroughly investigated, particularly compared to high-intensity statin monotherapy. We aimed to investigate the effect of ezetimibe combination with moderate-intensity statin in patients with atherosclerotic cardiovascular disease following PCI. Methods: This was a post-hoc analysis of a subset of patients who underwent PCI in the RACING trial. At 26 centres in South Korea, patients with atherosclerotic cardiovascular disease (ASCVD) were randomly assigned to receive either moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The prespecified endpoints of the RACING trial were used. The primary endpoint was the 3-year composite of cardiovascular death, major cardiovascular events, and nonfatal stroke. Event rates between the two groups were compared using log-rank tests, and hazard ratios (HR) with 95% confidence intervals (CI) were estimated using Cox regression analysis. Consistent with the RACING trial, the primary and secondary efficacy endpoints were evaluated using an intention-to-treatment approach, and the safety endpoints were assessed in the safety population. The RACING trial was registered at ClinicalTrials.gov (NCT03044665). Findings: Between Feb 14, 2017, and Dec 18, 2018, 3780 participants were enrolled in the RACING trial. Prior history of PCI was found in 2497 patients (67%, median 64 years, 79% male), and was associated with higher rates of the primary endpoint (hazard ratio [HR], 1.34; 95% confidence interval [CI], 1.06–1.69; p = 0.014). Among patients with prior PCI, moderate-intensity statin therapy with ezetimibe combination versus high-intensity statin therapy did not increase the risk of the primary endpoint (HR, 0.95; 95% CI, 0.74–1.24; p = 0.781). The proportion of patients with low-density lipoprotein cholesterol (LDL-C)

BackgroundAlthough ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) results in a significantly greater net clinical benefit over that with ticagrelor-based 12-month DAPT in patients with acute coronary syndrome (ACS), it remains uncertain whether this effect is dependent on body mass index (BMI). We aimed to evaluate the BMI-dependent effect of these treatment strategies on clinical outcomes.MethodsThis was a pre-specified subgroup analysis from the TICO trial (Ticagrelor Monotherapy After 3 Months in Patients Treated With New Generation Sirolimus-eluting Stent for Acute Coronary Syndrome), evaluating the interaction between BMI and treatment strategies for the primary outcome [composite of major bleeding and adverse cardiac and cerebrovascular events (MACCE): death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization]. The secondary outcomes were major bleeding and MACCE.ResultsBased on a pre-specified BMI threshold of 25 kg/m2, 3,056 patients were stratified. Patients with BMI

ObjectivesThis study aimed to evaluate and compare the diagnostic accuracy of machine learning (ML)- fractional flow reserve (FFR) based on optical coherence tomography (OCT) with wire-based FFR irrespective of the coronary territory.BackgroundML techniques for assessing hemodynamics features including FFR in coronary artery disease have been developed based on various imaging modalities. However, there is no study using OCT-based ML models for all coronary artery territories.MethodsOCT and FFR data were obtained for 356 individual coronary lesions in 130 patients. The training and testing groups were divided in a ratio of 4:1. The ML-FFR was derived for the testing group and compared with the wire-based FFR in terms of the diagnosis of ischemia (FFR ≤ 0.80).ResultsThe mean age of the subjects was 62.6 years. The numbers of the left anterior descending, left circumflex, and right coronary arteries were 130 (36.5%), 110 (30.9%), and 116 (32.6%), respectively. Using seven major features, the ML-FFR showed strong correlation (r = 0.8782, P < 0.001) with the wire-based FFR. The ML-FFR predicted wire-based FFR ≤ 0.80 in the test set with sensitivity of 98.3%, specificity of 61.5%, and overall accuracy of 91.7% (area under the curve: 0.948). External validation showed good correlation (r = 0.7884, P < 0.001) and accuracy of 83.2% (area under the curve: 0.912).ConclusionOCT-based ML-FFR showed good diagnostic performance in predicting FFR irrespective of the coronary territory. Because the study was a small-size study, the results should be warranted the performance in further large-scale research.

Objectives We evaluated the clinical impact of residual non-culprit left main coronary artery disease (LMCAD) on prognosis in patients undergoing emergent percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). Methods A total of 429 patients who underwent PCI for AMI complicated by CS was enrolled from 12 centers in the Republic of Korea. The patients were divided into two groups according to presence of non-culprit LMCAD or not: the LMCAD non-culprit group (n = 43) and the no LMCAD group (n = 386). Primary outcome was major adverse cardiac event (MACE, defined as a composite of cardiac death, myocardial infarction, or repeat revascularization). Propensity score matching analysis was performed to reduce selection bias and potential confounding factors. Results During a 12-month follow-up, a total of 168 MACEs occurred (LMCAD non-culprit group, 17 [39.5%] vs. no LMCAD group, 151 [39.1%]). Multivariate analysis revealed no significant difference in the incidence of MACE at 12 months between the LMCAD non-culprit and no LMCAD groups (adjusted hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.58 to 1.62, p = 0.901). After propensity score matching, the incidence of MACE was still similar between the two groups (HR 0.64; 95% CI 0.33 to 1.23; p = 0.180). The similarity of MACEs between the two groups was consistent across a variety of subgroups. Conclusions After adjusting for baseline differences, residual non-culprit LMCAD does not appear to increase the risk of MACEs at 12 months in patients undergoing emergent PCI for AMI complicated by CS.

Abstract Background The comparative clinical outcomes between prediabetes and type 2 diabetes mellitus (T2DM) in older adults with AMI in the era of newer-generation drug-eluting stents (DES) are limited. We investigated the 2-year clinical outcomes of these patients. Methods A total of 5492 AMI patients aged ≥65 years were classified into three groups according to their glycemic status: normoglycemia (group A: 1193), prediabetes (group B: 1696), and T2DM (group C: 2603). The primary outcome was the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization. The secondary outcome was stent thrombosis (ST). Results The primary and secondary outcomes cumulative incidences were similar between the prediabetes and T2DM groups. In both the prediabetes and T2DM groups, the cumulative incidences of MACE (adjusted hazard ratio [aHR]: 1.373; p = 0.020 and aHR: 1.479; p = 0.002, respectively) and all-cause death or MI (aHR: 1.436; p = 0.022 and aHR: 1.647; p = 0.001, respectively) were significantly higher than those in the normoglycemia group. Additionally, the cumulative incidence of all-cause death in the T2DM group was significantly higher than that in the normoglycemia group (aHR, 1.666; p = 0.003). Conclusions In this retrospective study, despite the 2-year clinical outcomes of the patients with prediabetes and T2DM in the older adults were worse than those in the normoglycemia group; they were similar between the prediabetes and T2DM groups. Hence, comparable treatment strategies should be strengthened between prediabetes and T2DM in older adults with AMI. Trial registration Retrospectively registered.

BackgroundThe efficacy of spot stenting using drug-eluting stents (DES) for the treatment of long femoropopliteal (FP) lesion is unknown. This study aimed to compare clinical outcomes of long full coverage vs. spot coverage with DES for long FP artery disease.MethodsThis multicenter randomized trial compared long DES vs. spot DES for FP lesions longer than 150 mm. All lesions were treated with paclitaxel-eluting stents (Zilver PTX). The primary endpoint was primary patency at 12 months.ResultsThe study was terminated early after an interim analysis. A total of 103 patients (55 in the long DES group; 48 in the spot DES group) were eligible for analysis. There were no significant differences in baseline and lesion characteristics between groups. Total stent length was longer in the long DES group than in the spot DES group (225.6 ± 67.2 vs. 131.3 ± 48.7 mm, p < 0.001). Technical success was achieved in all patients. There was a trend toward a higher primary patency rate at 12 months in the long DES group than in the spot DES group (87.5% vs. 67.5%, p = 0.120). The rate of survival free from target lesion revascularization was significantly higher in the long DES group than in the spot DES group (91.7% vs. 72.0%, p = 0.044). In multivariate Cox regression analysis, spot DES [hazard ratio (HR) 2.42, 95% confidence interval (CI) 1.14–5.12, p = 0.021] and postdilation (HR 0.27, 95% CI 0.09–0.79, p = 0.018) were identified as independent predictors for loss of patency at 12 months post-procedure.ConclusionsLong DES were more effective than spot DES for treating long FP lesions.Clinical trial registrationClinicaltrials.gov, identifier: NCT02701881.

Abstract Background Comparative studies regarding the long-term clinical outcomes of statin intensity between acute myocardial infarction (AMI) patients with prediabetes and those with type 2 diabetes mellitus (T2DM), after successful implantation of newer-generation drug-eluting stents (DES) with statin treatment, are limited. We compared the 2-year clinical outcomes between these patients. Methods A total of 11,612 AMI patients were classified as statin users (n = 9893) and non-users (n = 1719). Thereafter, statin users were further divided into high-intensity (n = 2984) or low-moderate-intensity statin (n = 6909) treatment groups. Those in these two groups were further classified into patients with normoglycemia, prediabetes, and T2DM. The major outcomes were the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat coronary revascularization. Results After adjusting for both high-intensity and low-moderate-intensity statin users, the cumulative incidences of MACE (p = 0.737, p = 0.062, respectively), all-cause death, Re-MI, and any repeat revascularization were similar between the prediabetes and T2DM groups. In the total study population, both high-intensity and low-moderate-intensity statin treatments showed comparable results. However, in the patients who enrolled after October 2012, the cumulative incidences of MACE (aHR 1.533; 95% CI 1.144–2.053; p = 0.004) and any repeat revascularization (aHR, 1.587; 95% CI 1.026–2.456; p = 0.038) were significantly lower in high-intensity statin users than in low-moderate intensity statin users. The beneficial effects of high-intensity compared to low-moderate-intensity statin therapy were more apparent in the normoglycemia group than hyperglycemia group, as it reduced the cumulative incidences of MACE (aHR 1.903; 95% CI 1.203–3.010; p = 0.006) and any repeat revascularization (aHR 3.248; 95% CI 1.539–6.854; p = 0.002). Conclusions In this retrospective registry study, prediabetes and T2DM groups showed comparable clinical outcomes, after administering both high-intensity and low-moderate-intensity statin treatments. However, these results are likely to be clearly proved by further studies, especially in patients with AMI who are being treated in contemporary practice. Trial registration Retrospectively registered.

Abstract We investigated the impact of pre-percutaneous coronary intervention (pre-PCI) thrombolysis in myocardial infarction (TIMI) flow grade (pre-TIMI) on 3-month (3-mo) and 12-mo of dual antiplatelet therapy (DAPT) in patients with acute myocardial infarction (AMI). This was a post hoc analysis of the TICO trial. A total of 2083 patients with AMI (pre-TIMI 0/1: n = 1143; pre-TIMI 2/3: n = 940) were evaluated. The primary outcome was the occurrence of net adverse clinical events (NACE), defined as a composite of TIMI major bleeding and major adverse cardiac and cerebrovascular events (MACCE) within 12-mo following PCI. The secondary outcomes were the occurrence of the individual components of TIMI bleedings and MACCE. In the pre-TIMI 0/1 group, the primary and second outcomes were not significantly different between the 3-mo and 12-mo DAPT groups. However, in the pre-TIMI 2/3 group, the occurrences of TIMI minor (adjusted hazard ratio [aHR]: 0.294; p = 0.016) and major or minor bleeding (aHR: 0.483; p = 0.014) on intention-to-treat analysis were significantly higher in the 12-mo than in the 3-mo DAPT group. The occurrence of MACCE was similar between the two groups. A higher bleeding tendency in 12-mo DAPT compared with 3-mo DAPT was more obvious in the pre-TIMI 2/3 group than in the pre-TIMI 0/1 group. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT02494895.

Abstract We investigated the effects of stent generation on 2-year clinical outcomes between prediabetes and diabetes patients after acute myocardial infarction (AMI). A total of 13,895 AMI patients were classified into normoglycemia (group A: 3673), prediabetes (group B: 5205), and diabetes (group C: 5017). Thereafter, all three groups were further divided into first-generation (1G)-drug-eluting stent (DES) and second-generation (2G)-DES groups. Patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization were the primary outcome. Stent thrombosis (ST) was the secondary outcome. In both prediabetes and diabetes groups, the cumulative incidences of POCOs, any repeat revascularization, and ST were higher in the 1G-DES than that in the 2G-DES. In the diabetes group, all-cause death and cardiac death rates were higher in the 1G-DES than that in the 2G-DES. In both stent generations, the cumulative incidence of POCOs was similar between the prediabetes and diabetes groups. However, in the 2G-DES group, the cumulative incidences of Re-MI and all-cause death or MI were significantly higher in the diabetes group than that in the prediabetes group. To conclude, 2G-DES was more effective than 1G-DES in reducing the primary and secondary outcomes for both prediabetes and diabetes groups.

BackgroundOptimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) who have undergone drug-eluting stent (DES) implantation is not clearly established. This study sought to impact of DAPT duration on real-world clinical outcome in patients with or without DM.MethodsUsing a nationwide cohort database, we investigate the association between DAPT duration and clinical outcome between 1 and 3 years after percutaneous coronary intervention (PCI). Primary outcome was all-cause death. Secondary outcomes were cardiovascular death, myocardial infarction, and composite bleeding events. After weighting, 90,100 DES-treated patients were included; 29,544 patients with DM and 60,556 without DM; 31,233 patients with standard DAPT (6–12 months) and 58,867 with prolonged DAPT (12–24 months).ResultsThe incidence of all-cause death was significantly lower in patients with prolonged DAPT [8.3% vs. 10.5% in those with standard DAPT, hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.72–0.84] in diabetic patients and non-diabetic patients (4.5% vs. 5.0% in those with standard DAPT, HR 0.89, 95% CI 0.83–0.96). The incidence of composite bleeding events was 5.7% vs. 5.4%, respectively, (HR 1.07, 95% CI 0.96–1.18) in diabetic patients and 5.6% vs. 5.0%, respectively, in non-diabetic patients (HR 1.13, 95% CI 1.05–1.21). There was a significant interaction between the presence of DM and DAPT duration for all-cause death (p for interaction, pint = 0.01) that further favored prolonged DAPT in diabetic patients. However, there was no significant interaction between the presence of DM and DAPT duration for composite bleeding events (pint = 0.38).ConclusionsThis study showed that prolonged rather than standard DAPT might be clinically beneficial in diabetic patients with DES implantation.Trial registrationClinicalTrial.gov (NCT04715594).

Background Despite the clinical benefits to intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI), most patients with coronary artery disease undergo angiography‐guided PCI alone in the real‐world setting. We sought to investigate the procedural characteristics of IVUS‐guided PCI and their clinical outcomes, as compared with angiography‐guided PCI. Methods and Results This was a cohort study using patient‐level data from the IVUS‐XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) and ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in All‐Comers Coronary Lesions) clinical trials. A total of 2848 patients with 3872 native coronary lesions were included and procedural characteristics assessed by quantitative coronary angiography (QCA) were compared between IVUS and angiography guidance. Stent‐to‐reference vessel diameter ratio (ie, QCA stent sizing) was greater (1.11±0.16 versus 1.07±0.14, P

BackgroundCoronary computed tomography angiography (CTA) and optical coherence tomography (OCT) provide additional functional information beyond the anatomy by applying computational fluid dynamics (CFD). This study sought to evaluate a novel approach for estimating computational fractional flow reserve (FFR) from coronary CTA-OCT fusion images.MethodsAmong patients who underwent coronary CTA, 148 patients who underwent both pressure wire-based FFR measurement and OCT during angiography to evaluate intermediate stenosis in the left anterior descending artery were included from the prospective registry. Coronary CTA-OCT fusion images were created, and CFD was applied to estimate computational FFR. Based on pressure wire-based FFR as a reference, the diagnostic performance of Fusion-FFR was compared with that of CT-FFR and OCT-FFR.ResultsFusion-FFR was strongly correlated with FFR (r = 0.836, P < 0.001). Correlation between FFR and Fusion-FFR was stronger than that between FFR and CT-FFR (r = 0.682, P < 0.001; z statistic, 5.42, P < 0.001) and between FFR and OCT-FFR (r = 0.705, P < 0.001; z statistic, 4.38, P < 0.001). Area under the receiver operating characteristics curve to assess functionally significant stenosis was higher for Fusion-FFR than for CT-FFR (0.90 vs. 0.83, P = 0.024) and OCT-FFR (0.90 vs. 0.83, P = 0.043). Fusion-FFR exhibited 84.5% accuracy, 84.6% sensitivity, 84.3% specificity, 80.9% positive predictive value, and 87.5% negative predictive value. Especially accuracy, specificity, and positive predictive value were superior for Fusion-FFR than for CT-FFR (73.0%, P = 0.007; 61.4%, P < 0.001; 64.0%, P < 0.001) and OCT-FFR (75.7%, P = 0.021; 73.5%, P = 0.020; 69.9%, P = 0.012).ConclusionCFD-based computational FFR from coronary CTA-OCT fusion images provided more accurate functional information than coronary CTA or OCT alone.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT03298282].

Background Several studies have shown that obesity is associated with better outcomes in patients with cardiogenic shock (CS). Although this phenomenon, the “obesity paradox,” reportedly manifests differently based on sex in other disease entities, it has not yet been investigated in patients with CS. Methods and Results A total of 1227 patients with CS from the RESCUE (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock) registry in Korea were analyzed. The study population was classified into obese and nonobese groups according to Asian Pacific criteria (BMI ≥25.0 kg/m2 for obese). The clinical impact of obesity on in‐hospital mortality according to sex was analyzed using logistic regression analysis and restricted cubic spline curves. The in‐hospital mortality rate was significantly lower in obese men than nonobese men (34.2% versus 24.1%, respectively; P=0.004), while the difference was not significant in women (37.3% versus 35.8%, respectively; P=0.884). As a continuous variable, higher BMI showed a protective effect in men; conversely, BMI was not associated with clinical outcomes in women. Compared with patients with normal weight, obesity was associated with a decreased risk of in‐hospital death in men (multivariable‐adjusted odds ratio [OR], 0.63; CI, 0.43–0.92 [P=0.016]), but not in women (multivariable‐adjusted OR, 0.94; 95% CI, 0.55–1.61 [P=0.828]). The interaction P value for the association between BMI and sex was 0.023. Conclusions The obesity paradox exists and apparently occurs in men among patients with CS. The differential effect of BMI on in‐hospital mortality was observed according to sex. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02985008.

Abstract Machine learning approaches using intravascular optical coherence tomography (OCT) to predict fractional flow reserve (FFR) have not been investigated. Both OCT and FFR data were obtained for left anterior descending artery lesions in 125 patients. Training and testing groups were partitioned in the ratio of 5:1. The OCT-based machine learning-FFR was derived for the testing group and compared with wire-based FFR in terms of ischemia diagnosis (FFR ≤ 0.8). The OCT-based machine learning-FFR showed good correlation (r = 0.853, P

Abstract Background Accurate measurement of the maximum aortic diameter (Dmax) is crucial for patients with abdominal aortic aneurysm (AAA). Aortic computed tomography (CT) provides accurate Dmax values by three-dimensional (3-D) reconstruction but may cause nephrotoxicity because of contrast use and radiation hazard. We aimed to evaluate the accuracy of a novel semi-automated 3-D ultrasonography (3-D US) system compared with that of CT as a reference. Methods Patients with AAA (n = 59) or individuals with normal aorta (n = 18) were prospectively recruited in an outpatient setting. Two-dimensional ultrasonography (2-D US) and 3-D US images were acquired with a single-sweep volumetric transducer. The analysis was performed offline with a software. Dmax and the vessel area of the Dmax slice were measured with 2-D US, 3-D US, and CT. The lumen and thrombus areas of the Dmax slice were also measured in 40 patients with intraluminal thrombus. Vessel and thrombus volumes were measured using 3-D US and CT. Results The Dmax values from 3-D US demonstrated better agreement (R 2 = 0.984) with the CT values than with the 2-D US values (R 2 = 0.938). Overall, 2-D US underestimated Dmax compared with 3-D US (32.3 ± 12.1 mm vs. 35.1 ± 12.0 mm). The Bland-Altman analysis of the 3-D US values, revealed better agreement with the CT values (2 standard deviations [SD], 2.9 mm) than with the 2-D US values (2 SD, 5.4 mm). The vessel, lumen, and thrombus areas all demonstrated better agreement with CT than with 2-D US (R 2 = 0.986 vs. 0.960 for the vessel, R 2 = 0.891 vs. 0.837 for the lumen, and R 2 = 0.977 vs. 0.872 for the thrombus). The thrombus volume assessed with 3-D US showed good correlation with the CT value (R 2 = 0.981 and 2 SD in the Bland-Altman analysis: 13.6 cm3). Conclusions Our novel semi-automated 3-D US analysis system provides more accurate Dmax values than 2-D US and provides precise volumetric data, which were not evaluable with 2-D US. The application of the semi-automated 3-D US analysis system in abdominal aorta assessment is easy and accurate.

BackgroundThe clinical implication of new-onset left bundle branch block (LBBB) after transcatheter aortic valve replacement (TAVR) remains controversial. We investigated the impact of new-onset persistent LBBB on reverse cardiac remodeling and clinical outcomes after TAVR.MethodsAmong 478 patients who had undergone TAVR for symptomatic severe aortic stenosis from 2011 to 2021, we analyzed 364 patients after excluding patients with pre-existing intraventricular conduction disturbance or a pacing rhythm before or during the indexed hospitalization for TAVR. Echocardiographic variables of cardiac remodeling at baseline and 1 year after TAVR were comprehensively analyzed. The primary outcome was a composite of cardiovascular death and hospitalization for heart failure. Secondary outcomes were all-cause death and individual components of the primary outcome.ResultNew-onset persistent LBBB occurred in 41 (11.3%) patients after TAVR. The no LBBB group showed a significant increase in the left ventricular (LV) ejection fraction and decreases in LV dimensions, the left atrial volume index, and LV mass index 1 year after TAVR (all p < 0.001). However, the new LBBB group showed no significant changes in these parameters. During a median follow-up of 18.1 months, the new LBBB group experienced a higher incidence of primary outcomes [hazard ratio (HR): 5.03; 95% confidence interval (CI): 2.60–9.73; p < 0.001] and all-cause death (HR: 2.80; 95% CI: 1.38–5.69; p = 0.003). The data were similar after multivariable regression analysis.ConclusionNew-onset persistent LBBB after TAVR is associated with insufficient reverse cardiac remodeling and increased adverse clinical events.

BackgroundIt is unclear whether beta-blocker treatment is advantageous in patients with stable coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). We evaluated the clinical impact of long-term beta-blocker maintenance in patients with stable CAD after PCI with drug-eluting stent (DES).MethodsFrom a nationwide cohort database, we identified the stable CAD patients without current or prior history of myocardial infarction or heart failure who underwent DES implantation. An intention-to-treat principle was used to analyze the impact of beta-blocker treatment on long-term outcomes of major adverse cardiovascular events (MACE) composed of cardiovascular death, myocardial infarction, and hospitalization with heart failure.ResultsAfter stabilized inverse probability of treatment weighting, a total of 78,380 patients with stable CAD was enrolled; 45,746 patients with and 32,634 without beta-blocker treatment. At 5 years after PCI with a 6-month quarantine period, the adjusted incidence of MACE was significantly higher in patients treated with beta-blockers [10.0 vs. 9.1%; hazard ratio (HR) 1.11, 95% CI 1.06–1.16, p < 0.001] in an intention-to-treat analysis. There was no significant difference in all-cause death between patients treated with and without beta-blockers (8.1 vs. 8.2%; HR 0.99, 95% CI 0.94–1.04, p = 0.62). Statistical analysis with a time-varying Cox regression and rank-preserving structure failure time model revealed similar results to the intention-to-treat analysis.ConclusionsAmong patients with stable CAD undergoing DES implantation, long-term maintenance with beta-blocker treatment might not be associated with clinical outcome improvement.Trial RegistrationClinicalTrial.gov (NCT04715594).

BackgroundDespite the theoretical benefits of biodegradable polymer drug-eluting stents (BP-DES), clinical benefits of BP-DES over durable polymer DES (DP-DES) have not been clearly demonstrated. Using data from a large-volume nationwide cohort, we compared long-term clinical outcomes between BP-DES- and DP-DES-treated patients.MethodsA retrospective cohort study that enrolled all patients who underwent percutaneous coronary intervention (PCI) with new-generation DES between 2010 and 2016 in Korea was conducted by using the National Health Insurance Service database. The outcomes of interest were all-cause death, cardiovascular death, and myocardial infarction (MI).ResultsA total of 127,731 patients treated with new-generation DES with thin struts (

Background: The impact of ticagrelor-based dual antiplatelet therapy (DAPT) on acute coronary syndrome (ACS) in patients with chronic kidney disease (CKD) remains unclear.Methods: Data on a total of 1,067 ACS patients with CKD including end-stage renal disease (ESRD) who underwent new-generation drug-eluting stent implantation were extracted from a multicenter registry. This study aimed to compare outcomes of patients treated with ticagrelor- (n = 449) and those treated with clopidogrel-based (n = 618) DAPT. Outcomes of interest included major adverse cardiac and cerebrovascular events (MACCEs) and bleeding (Bleeding Academic Research Consortium grade 3 or 5) at 12 months. Propensity-score matching (346 pairs) analysis was performed.Results: The patients with ESRD showed the highest MACCE and bleeding rates (P < 0.001). There was no difference in the rate of MACCEs between the treatment groups (7.8% vs. 8.4%; hazard ratio [HR] = 0.95, 95% confidence interval [CI] = 0.56–1.61, P = 0.855); however, a trend toward an increased bleeding rate was observed in the ticagrelor-based DAPT group (6.8% vs. 3.8%, HR = 1.84, 95% CI = 0.93–3.63, P = 0.079). Among patients with CKD stage III/IV but without ESRD (277 pairs), the ticagrelor-based DAPT group showed a reduced MACCE rate (3.6% vs. 8.7%, HR = 0.41, 95% CI = 0.19–0.86, P = 0.018) and a similar bleeding rate (5.1% vs. 3.2%, HR = 1.61, 95% CI = 0.70–3.71, P = 0.267), compared with those of the clopidogrel-based DAPT group.Conclusion: The effects of ticagrelor-based DAPT on ischemic and bleeding outcomes of ACS patients with CKD varied according to CKD stage; in ACS patients with CKD without ESRD, ticagrelor-based DAPT reduced MACCE risk without increasing bleeding risks, relative to those observed with clopidogrel-based DAPT.

Background We aimed to evaluate the age‐dependent effect of ticagrelor monotherapy after 3‐month dual‐antiplatelet therapy (DAPT) versus ticagrelor‐based 12‐month DAPT on major bleeding and cardiovascular events in patients with acute coronary syndrome. Methods and Results From the TICO trial (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus‐eluting Stent for Acute Coronary Syndrome), which randomized 3056 patients (median age, 61 years) to the ticagrelor monotherapy after 3‐month DAPT group or ticagrelor‐based 12‐month DAPT group, this post hoc analysis evaluated the age‐dependent effect of the treatment strategies on the primary end point (a composite of major bleeding, death, myocardial infarction, stent thrombosis, stroke, or target‐vessel revascularization) using the subpopulation treatment effect pattern plot. The cutoff age for distinguishing patients with greater benefit from this strategy was also determined. The risk reduction effect of ticagrelor monotherapy after 3‐month DAPT versus ticagrelor‐based 12‐month DAPT on the primary end point gradually increased with age and was more marked from the subpopulation of age 64 years with the change point. With this cutoff value of 64 years, the occurrence of the primary end point was significantly lower in the ticagrelor monotherapy after 3‐month DAPT group than in the ticagrelor‐based 12‐month DAPT group (4.4% versus 9.0%; P=0.002) in patients aged ≥64 years (n=1278), but it was not different in those aged

Objective: Currently, there are limited comparative data concerning long-term major clinical outcomes following the angiotensin-converting-enzyme inhibitors (ACEIs) and angiotensin II type 1 (AT1) receptor blockers (ARBs) therapy in patients with acute myocardial infarction (AMI) with dyslipidemia after a successful stent implantation. Therefore, we investigated major clinical outcomes for 2 years following the ACEIs and ARBs therapy in these patients. Methods: A total of 3015 patients with AMI who underwent a successful stent implantation and were prescribed ACEIs (n=2175) or ARBs (n=840) were enrolled into the study from the Korea AMI Registry (KAMIR). The major clinical endpoint was the occurrence of major adverse cardiac events (MACEs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat-revascularization-comprised target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR. Results: After the adjustment, the cumulative incidence of all-cause death in the ARBs group was significantly higher than in the ACEIs group [adjusted hazard ratio (aHR), 2.277; 95% confidence interval (CI), 1.154–4.495; p=0.018]. The cumulative incidences of MACEs (aHR, 1.305; 95% CI, 0.911–1.869; p=0.146), cardiac death, Re-MI, any repeat revascularization, TLR, TVR, and non-TVR were similar between the two groups. In addition, an advanced age (≥65 years), decreased left ventricular ejection fraction (

Background Although antiplatelet therapy (APT) has been recommended to balance ischemic‐bleeding risks, it has been left to an individualized decision‐making based on physicians' perspectives before non‐cardiac surgery. The study aimed to assess the advantages of a consensus among physicians, surgeons, and anesthesiologists on continuation and regimen of preoperative APT in patients with coronary drug‐eluting stents. Methods and Results A total of 3582 adult patients undergoing non‐cardiac surgery after percutaneous coronary intervention with second‐generation stents was retrospectively included from a multicenter cohort. Physicians determined whether APT should be continued or discontinued for a recommended period before non‐cardiac surgery. There were 3103 patients who complied with a consensus decision. Arbitrary APT, not based on a consensus decision, was associated with urgent surgery, high bleeding risk of surgery, female sex, and dual APT at the time of preoperative evaluation. Arbitrary APT independently increased the net clinical adverse event (adjusted odds ratio [ORadj], 1.98; 95% CI, 1.98–3.11), major adverse cardiac event (ORadj, 3.11; 95% CI, 1.31–7.34), and major bleeding (ORadj, 2.34; 95% CI, 1.45–3.76) risks. The association was consistently noted, irrespective of the surgical risks, recommendations, and practice on discontinuation of APT. Conclusions Most patients were treated in agreement with a consensus decision about preoperative APT based on a referral system among physicians, surgeons, and anesthesiologists. The risk of perioperative adverse events increased if complying with a consensus decision was failed. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03908463.

Background There is a lack of data on factors that are related to clinically relevant bleeding after ticagrelor treatment. We investigated the clinical and procedural factors related to major bleeding in patients with acute coronary syndrome treated with ticagrelor after coronary stent implantation. Methods and Results From the TICO (Ticagrelor Monotherapy After 3 Months in Patients Treated With New Generation Sirolimus‐Eluting Stent for Acute Coronary Syndrome) randomized trial, a total of 2660 patients were included for the present study. Patients with major bleeding, defined by TIMI (Thrombolysis in Myocardial Infarction) major or Bleeding Academic Research Consortium type 3 or 5, were compared with those without major bleeding. On the basis of multivariable and receiver operating characteristic curve analyses, weight ≤65 kg, hemoglobin ≤12 g/dL, and estimated glomerular filtration rate

Background and aimsThe prognosis of stented lesions differs according to in-stent neointimal characteristics on optical coherence tomography (OCT). In particular, patients who show in-stent heterogeneous neointima are associated with a higher incidence of target lesion revascularization (TLR) compared with those who show in-stent non-heterogeneous neointima. However, the relationship between in-stent neointimal characteristics and native coronary atherosclerosis progression has not been clearly elucidated. The study aimed to investigate the relationship between in-stent neointimal characteristics and progression of native atherosclerosis.MethodsThe neointimal characteristics of 377 patients with 377 drug-eluting stents (DESs) were quantitatively and qualitatively assessed using OCT. The OCT-based neointima was categorized as homogeneous (n = 207), heterogeneous (n = 93), and layered (n = 77). The relationship of non-target lesion revascularization (non-TLR) with neointimal characteristics was evaluated after OCT examination of the stents.ResultsAfter a median follow-up duration of 40.0 months, patients with heterogeneous neointima showed significantly higher non-TLR rates than those with homogeneous neointima and tended to have higher non-TLR rates than those with layered neointima (heterogeneous vs. homogeneous:14.0% vs. 8.7%, p = 0.046; heterogeneous vs. layered neointima:14.0% vs. 7.8%, p = 0.152). Multivariate analysis showed that the independent determinants for non-TLR were heterogeneous neointima (HR: 2.237, 95% CI: 1.023-4.890, p = 0.044) and chronic kidney disease (hazard ratio [HR]: 8.730, 95% CI: 2.175-35.036, p = 0.002).ConclusionsThe heterogeneous neointima in DES-treated lesions was associated with a higher incidence of non-TLR and target lesion failure. This finding suggests that the neointimal pattern may reflect the progression of the native lesion.

Background Continuing antiplatelet therapy (APT) has been generally recommended during noncardiac surgery, but it is uncertain if preoperative discontinuation of APT has been avoided or harmful in patients with second‐generation drug‐eluting coronary stents. Methods and Results Patients undergoing noncardiac surgery after second‐generation drug‐eluting coronary stent implantation were assessed in a multicenter cohort in Korea. Net adverse clinical events within 30 days postoperatively, defined as all‐cause death, major adverse cardiac events, and major bleeding, were evaluated. Of 3582 eligible patients, 49% patients discontinued APT during noncardiac surgery. The incidence of net adverse clinical events was comparable between patients with continuation versus discontinuation (4.1% versus 3.4%; P=0.257) of APT during noncardiac surgery. Perioperative discontinuation of APT did not impact on net adverse clinical events (adjusted hazard ratio [HR], 1.00; 95% CI, 0.69–1.44; P=0.995). In subgroup analysis, patients undergoing intra‐abdominal surgery were exposed to less risk of major bleeding by discontinuing APT (adjusted HR, 0.26; 95% CI, 0.08–0.91; P=0.035). Prolonged discontinuation of APT for ≥9 days was associated with higher risk of a major adverse cardiac event compared with continuing APT (adjusted HR, 3.38; 95% CI, 1.36–8.38; P=0.009). Conclusions APT was discontinued preoperatively in almost half of patients with second‐generation drug‐eluting coronary stents. Our explorative analysis showed that there was no significant impact of discontinuing APT on the risk of perioperative adverse events except that discontinuing APT may be associated with decreased hemorrhagic risk in patients undergoing intra‐abdominal surgery. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT03908463.

Abstract Background Asthma requires regular follow-up visits and sustained medication use. Although several studies have reported the importance of adherence to medication and compliance with the treatment, none to date have reported the importance of regular follow-up visits. We investigated the effects of regular clinical visits on asthma exacerbation. Methods We used claims data in the national medical insurance review system provided by the Health Insurance Review and Assessment Service of Korea. We included subjects aged ≥ 15 years with a diagnosis of asthma, and who were prescribed asthma-related medication, from July 2013 to June 2014. Regular visitors (frequent visitors) were defined as subjects who visited the hospital for follow-up of asthma three or more times per year. Results Among 729,343 subjects, 496,560 (68.1%) were classified as regular visitors. Old age, male sex, lack of medical aid insurance, attendance of a tertiary hospital, a high Charlson comorbidity index, and a history of admission for exacerbated asthma in the previous year were significant determining factors for regular visitor status. When we adjusted for all these factors, frequent visitors showed a lower risk of asthma exacerbation requiring general ward admission (odds ratio [OR] 0.48; 95% confidence interval [CI] 0.47–0.50; P

Objective. To compare major clinical outcomes after successful percutaneous coronary intervention (PCI) with first-generation (1G) drug-eluting stents (DES) and second-generation (2G) DES in patients with acute myocardial infarction (AMI) and prediabetes. Background. Patients with prediabetes are associated with an increased incidence of coronary artery disease. The relative superiority of 1G- and 2G-DES in these patients is not well established. Methods. A total of 4997 patients with AMI and prediabetes were divided into two groups: the 1D-DES group (n = 726) and the 2G-DES group (n = 4271). The primary outcomes were the patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any disease revascularization at 2-year follow-up. The secondary outcome was probable or definite stent thrombosis (ST). Results. After propensity score-matching (PSM) analysis, two PSM groups (698 pairs, n = 1396, C-statistics = 0.725) were generated. The cumulative incidence rates of POCOs (hazard ratio (HR): 1.467; 95% confidence interval (CI): 1.068–2.015; p=0.018), any disease revascularization (HR: 2.259; 95% CI: 1.397–3.654; p=0.001), and ST (HR: 4.361; 95% CI: 1.243–15.30; p=0.021) in the 1G-DES group were significantly higher than those in the 2G-DES group. However, the cumulative incidence rates of all-cause death, cardiac death, and Re-MI were similar between the two groups. Conclusions. In patients with AMI and prediabetes, 2G-DES implantation was more efficacious than 1G-DES implantation over a 2-year follow-up period. However, further studies are needed to confirm these results.

Background The effects of severe acute stent malapposition (ASM) after drug‐eluting stent implantation on long‐term clinical outcomes are not clearly understood. We evaluated long‐term clinical outcomes of severe ASM using optical coherence tomography. Methods and Results We pooled patient‐ and lesion‐level data from 6 randomized studies. Five studies investigated follow‐up drug‐eluting stent strut coverage and one investigated ASM. In this data set, a total of 436 patients with 444 lesions underwent postintervention optical coherence tomography examination and these data were included in the analysis. Severe ASM was defined as lesions with ≥400 μm of maximum malapposed distance or ≥1 mm of maximum malapposed length. Composite events (cardiac death, target lesion–related myocardial infarction, target lesion revascularization, and stent thrombosis) were compared between patients with and without severe ASM. The postintervention optical coherence tomography findings indicated that 62 (14.2%) patients had lesions with ≥400 μm of maximum malapposed distance and 186 (42.7%) patients had lesions with ≥1 mm of maximum malapposed length. The 5‐year clinical follow‐up was completed in 371 (86.1%) of the eligible 431 patients. The cumulative rate of composite events was similar among the patients in each group during 5‐year follow‐up: 3.3% in patients with ASM ≥400 μm of maximum malapposed distance versus 3.1% in those with no ASM or ASM

Background The relationship between late stent malapposition (LSM) and adverse cardiovascular events is controversial. Studies are needed to evaluate long‐term (>5 years) clinical outcomes of LSM detected by optical coherence tomography (OCT) after drug‐eluting stent implantation. Methods and Results We investigated long‐term clinical outcomes of OCT‐detected LSM in 351 patients who received drug‐eluting stents and were examined by both poststent and follow‐up OCT (175±60 days after drug‐eluting stent implantation) from January 2009 to December 2011. LSM was observed in 99 patients (28%). We evaluated the cumulative rate of composite events (cardiovascular death, target‐vessel–related myocardial infarction, target‐vessel revascularization, and stent thrombosis). During 80.1±24.5 months of follow‐up, very late stent thrombosis did not occur in any patients with LSM. The cumulative 8‐year rate of composite events was 7.3% in patients with LSM and 10.5% in patients without LSM (P=0.822, log‐rank test). We further divided patients into the following 4 groups: patients with both late‐persistent and late‐acquired stent malapposition (n=23), patients with late‐persistent stent malapposition alone (n=45), patients with late‐acquired stent malapposition alone (n=31), and patients without LSM (n=252). The cumulative 8‐year rates of composite events were similar among these 4 groups (0%, 9.6%, 9.7%, and 10.5%, respectively; P=0.468 by log‐rank test). Conclusions During long‐term follow‐up (>5 years), very late stent thrombosis did not occur in patients with OCT‐detected LSM. The rates of adverse clinical events were similar between patients with LSM versus those without LSM. Presence of OCT‐detected LSM was not associated with unfavorable clinical outcomes.