19 results on '"Brugaletta, S"'
Search Results
2. Immediate versus staged complete revascularization in acute coronary syndrome: A meta-analysis of randomized controlled trials.
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Bujak K, Rinaldi R, Vidal-Cales P, Montone RA, Diletti R, Gąsior M, Crea F, Sabaté M, and Brugaletta S
- Abstract
Background: Clinical guidelines recommend a complete revascularization (CR) in patients with acute coronary syndromes (ACS) and multivessel disease (MVD). However, its optimal timing is unclear. The aim of this meta-analysis was to compare the clinical outcomes following immediate versus staged CR in ACS., Methods: PubMed and Scopus were searched until March 2023 for randomized controlled trials (RCTs) comparing immediate versus staged CR. The primary endpoint was major adverse cardiovascular event (MACE) at the longest follow-up. Secondary outcomes were all-cause death, cardiovascular death, myocardial infarction (MI), any unplanned revascularization, target-vessel revascularization (TVR), and stent thrombosis. Safety outcomes were major bleeding, contrast volume, procedure duration, and length of hospitalization., Results: Eight RCTs were included (3559 patients, weighted mean follow-up 12.5 months). There were no differences in the primary endpoint (OR 0.74, 95%CI: 0.54-1.01) and in the secondary endpoints of death, and stent thrombosis between the two CR strategies. Immediate CR was associated with a lower risk of recurrent MI (OR 0.51, 95% CI 0.34-0.76), any unplanned revascularization (OR 0.59, 95%CI: 0.43-0.80), and TVR (OR 0.61, 95% CI 0.45-0.84) compared to staged CR. Immediate CR was also associated with lower total contrast volume and shorter total procedure duration and hospitalization length compared to staged CR without differences in major bleedings., Conclusion: No difference was found between immediate and staged CR regarding MACE, or deaths rates at one year. Immediate CR may be associated with a lower risk of recurrent MI and unplanned coronary revascularization than staged CR., Competing Interests: Declaration of Competing Interest All authors declare no conflict of interest for this work., (Copyright © 2023. Published by Elsevier B.V.)
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- 2023
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3. Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry.
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Gallo F, Gallone G, Kim WK, Reifart J, Veulemans V, Zeus T, Toggweiler S, De Backer O, Søndergaard L, De Marco F, Regazzoli D, Reimers B, Muntané-Carol G, Estevez-Loureiro R, Hernandez U, Moscarelli M, Airale L, D'Ascenzo F, Armario X, Mylotte D, Bhadra OD, Conradi L, Donday LAM, Nombela-Franco L, Barbanti M, Reddavid C, Criscione E, Brugaletta S, Nicolini E, Piva T, Tzanis G, Ronco F, Barbierato M, Rodes-Cabau J, Mangieri A, Colombo A, and Giannini F
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- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Prosthesis Design, Registries, Retrospective Studies, Time Factors, Treatment Outcome, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis etiology, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement adverse effects
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Objectives: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota)., Background: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting., Methods: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes., Results: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157)., Conclusions: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation., (Copyright © 2022 Elsevier B.V. All rights reserved.)
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- 2022
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4. Aortic angle distribution and predictors of horizontal aorta in patients undergoing transcatheter aortic valve replacement.
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Moscarelli M, Gallo F, Gallone G, Kim WK, Reifart J, Veulemans V, Zeus T, Toggweiler S, De Backer O, Søndergaard L, Mangieri A, De Marco F, Regazzoli D, Reimers B, Muntané-Carol G, Lauriero RE, Armario X, Mylotte D, Bhadra OD, Conradi L, Donday LAM, Nombela-Franco L, Barbanti M, Reddavid C, Brugaletta S, Nicolini E, Tzanis G, Rodes-Cabau J, Colombo A, and Giannini F
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- Aorta, Aortic Valve diagnostic imaging, Aortic Valve surgery, Europe, Female, Humans, Male, Prospective Studies, Retrospective Studies, Risk Factors, Severity of Illness Index, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Transcatheter Aortic Valve Replacement adverse effects
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Background: Horizontal aorta (HA) is an anatomical feature that can pose significant technical challenges for the successful positioning of the bioprosthetic valve during transcatheter aortic valve replacement (TAVR). Physiological range of aortic angle (AA) is unknown; hence there is no cutoff AA for classifying HA. Moreover, patient characteristics predicting HA are under-investigated., Methods: This was a retrospective analysis of prospective collected data from 16 heart valve centers in Europe. The study utilized a common dataset with a priori agreed-upon definitions and variables. Eligible patients underwent TAVR between 2014 and 2020 and had multidetector computed tomographic imaging data available for determining the AA. The analysis described the distribution of AA and potential predictors of HA. Inter-center variability was also explored., Results: For 4022 patients analyzed, the mean AA ± standard deviation was 49.4° ± 9.4° (median 49°, inter-quartile range [IQR] 12°, range 18-90°). There was no significant difference in mean AA between men and women (49.4° ± 9.1° vs. 49.6° ± 9.3°, respectively; p = 0.53); therefore, 49.4° was accepted as the cutoff value for HA in subsequent analyses. Covariates significantly associated with HA included age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p < 0.001), body mass index (OR: 1.06, 95% CI: 1.05-1.08, p < 0.01), previous cardiac surgery (OR: 0.58, 95% CI: 0.45-0.75, p < 0.001), and porcelain aorta (OR: 0.66, 95% CI: 0.52-0.85, p = 0.001). Some inter-center variability was observed., Conclusions: We defined 49.4° as the mean AA, and also associated predictors of HA in a large case series of patients with severe aortic stenosis candidates for TAVR., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 Elsevier B.V. All rights reserved.)
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- 2021
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5. Sex-based differences in chronic total occlusion management and long-term clinical outcomes.
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Flores-Umanzor EJ, Cepas-Guillen PL, Caldentey G, Pérez-Fuentes P, Arévalos V, Ivey-Miranda J, Regueiro A, Freixa X, Brugaletta S, Farrero M, Andrea R, Roquè M, Ferreira-González I, Martin-Yusté V, and Sabaté M
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- Aged, Chronic Disease, Coronary Angiography, Female, Follow-Up Studies, Humans, Male, Middle Aged, Percutaneous Coronary Intervention, Risk Factors, Sex Characteristics, Stroke Volume, Treatment Outcome, Coronary Occlusion diagnostic imaging, Coronary Occlusion epidemiology
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Background: Sex differences in coronary artery disease presentation and outcomes have been described. The aim of this study was to compare sex disparities in chronic total occlusion (CTO) management and long-term outcomes., Methods: All consecutive patients with at least one CTO diagnosed in our center between 2010 and 2014 were included. Demographic and clinical data were registered. All-cause and cardiac mortality were assessed during a median follow-up of 4.03 years (IQR 2.6-4.8)., Results: A total of 1248 patients (67.3 ± 10.9 years; 16% female) were identified. Women were older, had a higher prevalence of type 2 DM and a lower ventricle ejection fraction compared to men (p < .05). Although women had major proportion of positive result for severe ischemia-viability test (86% vs. 74%; p = .01), they were more often treated with MT alone compared to male (57% vs 51%; p = .02). During follow-up, 386 patients (31%) died. Women presented a higher rate of all-cause and cardiac mortality, and hospitalizations for heart failure independently of treatment strategy, compared to men (p < .001). In multivariable analysis female sex was associated with higher cardiac mortality [HR 1.67, 95% CI 1.10-2.57; p < .001]. Among women, the independent predictors for all-cause and cardiac mortalities were age, MT of the CTO and ACEF (age, creatinin and ejection fraction) score., Conclusions: A significant sex gap regarding CTO treatment was observed. Female sex was an independent predictor for cardiac mortality at long-term follow-up. More data are needed to support these findings., (Copyright © 2020 Elsevier B.V. All rights reserved.)
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- 2020
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6. Comparison of clinical outcomes in STEMI patients treated with primary PCI according to day-time of medical attention and its relationship with circadian pattern.
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Rodríguez-Arias JJ, Ortega-Paz L, Brugaletta S, Freixa X, Masotti M, Regueiro A, Ariza A, Carrillo X, Lidon RM, Garcia J, Cardenas M, Rojas SG, Muñoz JF, Zielonka M, Tizon-Marcos H, and Sabaté M
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- Hospital Mortality, Hospitals, Humans, Time Factors, Treatment Outcome, Myocardial Infarction, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction diagnostic imaging, ST Elevation Myocardial Infarction surgery
- Abstract
Objective: Relationship between STEMI time of presentation, its circadian pattern and cardiovascular outcomes is unclear. Our objective is to analyze clinical outcomes of STEMI according to time of presentation and circadian pattern., Methods: We analyzed data from patients treated within the regional STEMI Network from January 2010 to December 2015. On-hour group included patients treated between 8:00 h and 19:59 h on weekdays, the rest were catalogued as off-hour group. The primary endpoint was 1-year all-cause mortality. Secondary endpoints were 30-day all-cause mortality and in-hospital complications., Results: A total of 8608 patients were included, 44.1% in the on-hour group and 55.9% in the off-hour group. We observed a shorter patient delay and longer system delay in the off-hour group compared to on-hour group with no difference in total ischemic time. At 30-day and 1-year follow-up there were no differences in adjusted all-cause mortality between groups [OR 0.91 (CI95%: 0.73-1.12; p = 0.35) and OR 0.99 (CI95%: 0.83-1.17; p = 0.87), respectively]. A circadian pattern was observed between 9:00 am and 12:30 pm, with no differences in 30-day and 1-year mortality between patients included in this time interval [OR 1.02 (IC95%: 0.81-1.30; p = 0.85) and OR 1.12 (IC95%: 0.92-1.36; p = 0.25) respectively]., Conclusions: Off-hour STEMI presentation was associated with a shorter patient delay and longer system delay without an increase in total ischemic time. The off-hour presentation was not related to an increase in 1-year all-cause mortality when compared to on-hour. A circadian pattern was found, without differences in 30-day and 1-year mortality., Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)
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- 2020
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7. Endothelial function impairment in STEMI patients with out-of-hospital cardiac arrest under therapeutic hypothermia treatment.
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Brugaletta S, Scalone G, Dantas AP, Ortega-Paz L, Garabito M, Roqué M, Martin V, Masotti M, Freixa X, and Sabaté M
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- Coronary Angiography, Electrocardiography, Female, Follow-Up Studies, Humans, Male, Middle Aged, Out-of-Hospital Cardiac Arrest etiology, Out-of-Hospital Cardiac Arrest therapy, Prognosis, Retrospective Studies, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction physiopathology, Endothelium, Vascular physiopathology, Hypothermia, Induced methods, Out-of-Hospital Cardiac Arrest physiopathology, ST Elevation Myocardial Infarction complications, Vasodilation physiology
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Background: Therapeutic hypothermia (HT) in out-of-hospital cardiac arrest STEMI patients aims to improve their neurological prognosis, but it has been associated with slow coronary flow and cardiac thrombotic events. We sought to serially assess endothelial function during the first 48h after admission in out-of-hospital cardiac arrest STEMI patients, under therapeutic hypothermia (HT)., Methods: From January 2015 to August 2015, eighteen consecutive out-of-hospital cardiac arrest STEMI patients eligible for primary PCI received HT at admission and were included in the study (HT group). During the same time period, eight consecutive patients with large anterior STEMI who received primary PCI but not HT were included as control group. Serial endothelial function by measuring flow-mediated dilatation (FMD) in the brachial artery, biomarkers of endothelial function and oxidative stress were assessed during the first 48h after admission in both groups., Results: HT group showed worse FMD as compared to the control group (p<0.001). Glutathione peroxidase-3 (GPx-3) values were higher in control as compared to HT group (p=0.019), without any interaction between time of observation and HT (p=0.864). A significant interaction between time and HT was found in the levels of sVCAM-1, which reached an earlier peak in control than in HT group (p=0.019). ET-1 values generally increase overtime (p=0.005), but without any main effect of HT (p=0.175)., Conclusions: HT is associated with endothelial dysfunction in out-of-hospital cardiac arrest STEMI patients during the first 48h after admission. This vascular dysfunction may be related to increased oxidative stress due to deficiency of GPx-3 in HT patients., (Copyright © 2017 Elsevier B.V. All rights reserved.)
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- 2017
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8. Can new generation P2Y12 inhibitors play a role in microvascular obstruction in STEMI?
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Vannini L, Muro A, Sanchis J, Ortiz-Pérez JT, Flores Umanzor E, López-Lereu MP, Badimon L, Sabaté M, and Brugaletta S
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- Adenosine therapeutic use, Aged, Female, Humans, Magnetic Resonance Imaging, Male, Microvessels, Middle Aged, ST Elevation Myocardial Infarction diagnostic imaging, ST Elevation Myocardial Infarction physiopathology, Ticagrelor, Adenosine analogs & derivatives, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors therapeutic use, Prasugrel Hydrochloride therapeutic use, Purinergic P2Y Receptor Antagonists therapeutic use, ST Elevation Myocardial Infarction therapy
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- 2016
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9. ABSORB bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in ST-segment elevation myocardial infarction (BVS EXAMINATION study): 2-Year results from a propensity score matched comparison.
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Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, Ortega-Paz L, Schulz E, Chan MY, Kocka V, Hurtado J, Gomez-Hospital JA, Giacchi G, Münzel T, Lee CH, Cequier A, Valdés M, Widimsky P, Serruys PW, and Sabaté M
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- Absorbable Implants, Drug-Eluting Stents, Female, Humans, Male, Platelet Aggregation Inhibitors administration & dosage, Propensity Score, Survival Analysis, Tissue Scaffolds, Treatment Outcome, Everolimus administration & dosage, Prosthesis Implantation instrumentation, ST Elevation Myocardial Infarction therapy
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- 2016
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10. Bioresorbable Scaffold vs. Second Generation Drug Eluting Stent in Long Coronary Lesions requiring Overlap: A Propensity-Matched Comparison (the UNDERDOGS study).
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Biscaglia S, Ugo F, Ielasi A, Secco GG, Durante A, D'Ascenzo F, Cerrato E, Balghith M, Pasquetto G, Penzo C, Fineschi M, Bonechi F, Templin C, Menozzi M, Aquilina M, Rognoni A, Capasso P, Di Mario C, Brugaletta S, and Campo G
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- Aged, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Registries, Treatment Outcome, Absorbable Implants trends, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Drug-Eluting Stents trends, Propensity Score
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Background: Randomized clinical trials on bioresorbable scaffolds (BRS) enrolled patients with simple coronary lesions. The present study was sought to give preliminary findings about safety of BRS implantation in overlap in long coronary lesions., Methods: From June 2012 to January 2015, we prospectively collected data from 162 consecutive patients receiving overlapping BRS implantation in the 16 participating institutions. We applied a propensity-score to match BRS-treated patients with 162 patients receiving second generation drug eluting stents (DES) in overlap. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization., Results: DOCE rate did not significantly differ between the two groups (5.6% in BRS group vs. 7.4% in DES group, HR 0.79, 95%CI 0.37-3.55, p=0.6). Also stent/scaffold thrombosis did not differ between groups (1.2% in BRS group vs. 1.9% in DES group, p=0.6). Occurrence of procedural-related myocardial injury was significantly higher in the BRS group (25% vs. 12%, p=0.001), although it was not related to DOCE (HR 1.1, 95%CI 0.97-1.2, p=0.2). Imaging techniques and enhanced stent visualization systems were significantly more employed in the BRS group (p=0.0001 for both). Procedure length, fluoroscopy time and contrast dye amount were significantly higher in the BRS group (p=0.001, p=0.001 and p=0.01, respectively)., Conclusions: Overlapping BRS utilization in long coronary lesions showed a comparable DOCE rate at 1year if compared to second generation DES. Further and larger studies are on demand to confirm our findings., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)
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- 2016
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11. Levosimendan as an adjunctive therapy to MitraClip implantation in patients with severe mitral regurgitation and left ventricular dysfunction.
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Freixa X, Hernández M, Farrero M, Sitges M, Jiménez G, Regueiro A, Fita G, Tatjer I, Andrea R, Martín-Yuste V, Brugaletta S, Masotti M, and Sabaté M
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- Adult, Aged, Combined Modality Therapy methods, Female, Heart Valve Prosthesis Implantation methods, Humans, Male, Middle Aged, Mitral Valve Insufficiency diagnostic imaging, Severity of Illness Index, Simendan, Ultrasonography, Vasodilator Agents administration & dosage, Ventricular Dysfunction, Left diagnostic imaging, Heart Valve Prosthesis Implantation instrumentation, Hydrazones administration & dosage, Mitral Valve Insufficiency drug therapy, Mitral Valve Insufficiency surgery, Pyridazines administration & dosage, Ventricular Dysfunction, Left drug therapy, Ventricular Dysfunction, Left surgery
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- 2016
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12. Everolimus-eluting stent versus bare-metal stent in elderly (≥75 years) versus non-elderly (<75 years) patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: insights from the examination trial.
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Ielasi A, Brugaletta S, Silvestro A, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, den Heijer P, Bethencourt A, Vazquez N, Serruys P, Sabate M, and Tespili M
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- Age Factors, Aged, Cause of Death, Combined Modality Therapy, Coronary Angiography, Everolimus, Female, Humans, Male, Myocardial Infarction diagnostic imaging, Myocardial Infarction mortality, Prognosis, Recurrence, Risk Factors, Sirolimus administration & dosage, Treatment Outcome, Drug-Eluting Stents, Immunosuppressive Agents administration & dosage, Myocardial Infarction therapy, Percutaneous Coronary Intervention, Sirolimus analogs & derivatives
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Background: The elderly (≥75years) constitute a high-risk subset of patients who continue to have a poorer prognosis than non-elderly (<75years). Whether the effects of everolimus-eluting stent (EES) in ST-segment elevation myocardial infarction (STEMI) are independent of age has not been reported. We investigated the outcomes following primary PCI (PPCI) with bare-metal stent (BMS) or EES in elderly vs. non-elderly STEMI patients., Methods: The EXAMINATION trial randomized 1498 STEMI patients to BMS or EES. The primary patient-oriented endpoint (POCE) was the combined of all-cause death, any-recurrent myocardial infarction (MI) and any-revascularization at 1-year. The secondary endpoint included the device-oriented combined (DOCE) of cardiac death, target-vessel MI and target-lesion revascularization. These endpoints and their components were compared between elderly and non-elderly., Results: Among patients enrolled in the trial, 245 (16.3%) were elderly, allocated to BMS (n=132) or EES (n=113), while the remaining 1253 (83.7%) were non-elderly, allocated to BMS (n=615) or EES (n=638). At 1-year, both the POCE and DOCE were observed more frequently in elderly vs. non-elderly group (24.5% vs. 10.5%, p<0.001 and 15.9% vs. 5.1%, p<0.001). Whereas in non-elderly, both POCE and DOCE were lower in EES vs. BMS (12.4% vs. 8.8%, p=0.03 and 6.7% vs. 3.6%, p=0.01), no differences were found in elderly, with a tendency for interaction between age and stent type for POCE (p=0.05). On multivariate analysis age ≥75 years was an independent predictor of POCE (HR 2.19 [95%CI 1.59-3.01], p<0.0001) and DOCE (HR 2.42 [95%CI 1.60-3.7], p<0.001) at 1-year., Conclusions: In STEMI patients undergoing PPCI, advanced age (≥75 years) is associated with worse outcomes. The beneficial effects of EES over BMS tended to be age-dependent., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)
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- 2015
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13. Platelet reactivity assessment with VerifyNow®: substitute or complement for light transmission aggregometry?
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Regueiro A, Freixa X, Fernández-Rodríguez D, Diaz-Ricart M, Escolar G, Martín-Yuste V, Brugaletta S, Sabaté M, and Masotti M
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- Blood Platelets drug effects, Coronary Artery Disease blood, Coronary Artery Disease drug therapy, Female, Humans, Male, Platelet Activation drug effects, Platelet Aggregation Inhibitors pharmacology, Platelet Aggregation Inhibitors therapeutic use, Platelet Function Tests methods, Platelet Function Tests standards, Prospective Studies, Receptors, Purinergic P2Y12 blood, Blood Platelets physiology, Photic Stimulation methods, Platelet Activation physiology
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- 2015
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14. Impact of therapeutic hypothermia on coronary flow.
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Regueiro A, Freixa X, Heras M, Penela D, Fernández-Rodríguez D, Brugaletta S, Martín-Yuste V, Masotti M, and Sabaté M
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- Adult, Aged, Female, Humans, Male, Middle Aged, Out-of-Hospital Cardiac Arrest mortality, Thrombosis mortality, Coronary Circulation physiology, Endothelium, Vascular physiology, Hypothermia, Induced adverse effects, Out-of-Hospital Cardiac Arrest therapy, Thrombosis etiology
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- 2014
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15. Predictors and clinical implications of stent thrombosis in patients with ST-segment elevation myocardial infarction: Insights from the EXAMINATION trial.
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Brugaletta S, Sabate M, Martin-Yuste V, Masotti M, Shiratori Y, Alvarez-Contreras L, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Lara J, Backx B, and Serruys PW
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- Female, Humans, Male, Middle Aged, Myocardial Infarction physiopathology, Prospective Studies, Single-Blind Method, Drug-Eluting Stents adverse effects, Myocardial Infarction therapy, Thrombosis etiology
- Abstract
Background: Few data are available about safety of second generation drug eluting stents in an all-comer ST elevation myocardial infarction (STEMI) population. We sought to investigate the predictors and clinical implications of 1-year stent thrombosis (ST) in patients with STEMI, included in the EXAMINATION trial., Methods and Results: The EXAMINATION trial is an all-comer prospective, randomized 1:1 controlled trial, testing everolimus-eluting stent (EES) vs. cobalt chromium bare metal stent (BMS) in STEMI patients. It included 1498 patients, randomized to EES (n = 751) or BMS (n = 747). At 1 year, definite/probable stent thrombosis, defined according to ARC criteria, occurred in 26 patients (1.73%), including 18 definite and 8 probable events. The incidence of ST was lower in patients treated with EES than in those treated with BMS (HR 0.16, 95% CI 0.03-0.29, p = 0.017). Patients with ST have higher 1-year rates of cardiac death (30.8% vs. 2.5%, p<0.001), myocardial infarction (30.8% vs. 0.5%, p<0.001) and target vessel revascularization (65.4% vs. 4.2%, p<0.001) compared with those without. Independent predictors of 1-year definite/probable ST were BMS implantation at the index procedure (HR 3.41, 95% CI 1.35-8.60), ST segment resolution of at least 70% in the EKG post-PCI (HR 0.30, 95% CI 0.13-0.70) and Killip class on admission (HR 2.57, 95% CI 1.70-3.90)., Conclusions: ST had low frequency in the first year after implantation of EES/BMS in STEMI patients, but it is associated with adverse events. BMS implantation, lack of ST-segment resolution and high Killip class on admission were independent predictors of 1-year ST., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)
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- 2013
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16. Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry.
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Sabaté M, Brugaletta S, Abizaid A, Banning A, Bartorelli A, Džavík V, Ellis S, Holmes D, Gao R, Jeong MH, Legrand V, Neumann FJ, Nyakern M, Spaulding C, Stoll HP, Worthley S, and Urban P
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- Aged, Female, Humans, Male, Middle Aged, Prosthesis Implantation, Registries, Time Factors, Treatment Outcome, Drug-Eluting Stents, Platelet Aggregation Inhibitors therapeutic use, Sirolimus administration & dosage, Thrombosis prevention & control, Vitamin K antagonists & inhibitors
- Abstract
Background: Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown., Methods: A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months., Results: The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P<0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. the NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P<0.04 and P<0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p=0.4)., Conclusions: Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)
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- 2013
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17. First experience of a bioresorbable vascular scaffold implantation in left main stenosis.
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Fernández D, Brugaletta S, Martín-Yuste V, Regueiro A, de Mingo A, Santos A, Masotti M, and Sabaté M
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- Humans, Male, Middle Aged, Radiography, Absorbable Implants standards, Coronary Stenosis diagnostic imaging, Coronary Stenosis surgery, Tissue Scaffolds standards
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- 2013
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18. Lipid core burden index and Framingham score: can a Systemic Risk Score predict lipid core burden in non-culprit coronary artery?
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Heo JH, Garcia-Garcia HM, Brugaletta S, de Boer S, Simsek C, Farooq V, Boersma E, and Serruys PW
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- Coronary Artery Disease etiology, Humans, Predictive Value of Tests, Risk Factors, Coronary Artery Disease diagnosis, Coronary Vessels pathology, Lipids, Severity of Illness Index
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- 2012
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19. Effect of intensive vs standard statin therapy on endothelial progenitor cells and left ventricular function in patients with acute myocardial infarction: Statins for regeneration after acute myocardial infarction and PCI (STRAP) trial.
- Author
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Leone AM, Rutella S, Giannico MB, Perfetti M, Zaccone V, Brugaletta S, Garramone B, Niccoli G, Porto I, Liuzzo G, Biasucci LM, Bellesi S, Galiuto L, Leone G, Rebuzzi AG, and Crea F
- Subjects
- Aged, Atorvastatin, Cell Count, Combined Modality Therapy, Endothelial Cells cytology, Female, Follow-Up Studies, Hematopoietic Stem Cells cytology, Hematopoietic Stem Cells drug effects, Humans, Male, Middle Aged, Stroke Volume drug effects, Treatment Outcome, Angioplasty, Balloon, Coronary, Hematopoietic Stem Cell Mobilization methods, Heptanoic Acids administration & dosage, Hydroxymethylglutaryl-CoA Reductase Inhibitors administration & dosage, Myocardial Infarction drug therapy, Pyrroles administration & dosage, Ventricular Function, Left drug effects
- Abstract
Background: Intensive statin therapy can lower the risk of recurrence of major cardiac events in patients with acute coronary syndromes. This could be related to the ability of statins to increase levels of Endothelial Progenitor Cells (EPCs), which were demonstrated to be favorably associated with a better prognosis and post-infarction left ventricular remodeling in patients with ischemic heart disease., Aim of the Study: First, to evaluate, in a randomized clinical trial, the effect of an intensive vs a standard treatment with statins on EPC mobilization in patients undergoing a successful primary or rescue percutaneous coronary intervention; secondary, to evaluate whether left ventricular remodeling could be influenced by statin therapy through EPC mobilization., Methods: Forty ST-segment elevation myocardial infarction (STEMI) patients undergoing a successful primary or rescue PCI were randomized to receive atorvastatin 80 mg immediately after the admission (Intensive Treatment, IT) or atorvastatin 20 mg from the day of the discharge (Standard Treatment, ST). CD34+/KDR+ EPC count by flow cytometry and left ventricular function by 2-D Echo were measured on admission, at discharge and at 4 months follow up., Results: We found that EPC count was similar in the two groups of patients both on admission and at discharge. At follow up, however, EPC count was higher in patients randomized to IT compared to patients randomized to ST (7.59+/-7.30 vs 3.04+/-3.93, p=0.04). However, LV volumes, ejection fraction and wall motion score index were similar in both groups., Conclusions: An intensive statin treatment after primary or rescue PCI is associated with a higher EPC count at follow up as compared to standard treatment. This beneficial effect did not translate in an improvement of LV function.
- Published
- 2008
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