Comparative Safety and Effectiveness of Ticagrelor versus Clopidogrel in Patients With Acute Coronary Syndrome: An On-Treatment Analysis From a Multicenter Registry.

Background: The net clinical benefit of ticagrelor over clopidogrel in acute coronary syndrome (ACS) has recently been questioned by observational studies which did not account for time-dependent confounders. We aimed to assess the comparative safety and effectiveness of ticagrelor vs. clopidogrel accounting for non-adherence in a real-life setting. Methods: This is a prospective, multicenter cohort study of patients with ACS discharged on ticagrelor or clopidogrel between 2015 and 2019. Major exclusions were previous intracranial bleeding, and the use of prasugrel or oral anticoagulation. Association of P2Y12 inhibitor therapy with 1-year risk of Bleeding Academic Research Consortium Type 3 or 5 bleeding; major adverse cardiac events (MACEs), a composite endpoint of all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke, or urgent target lesion revascularization; definite/probable stent thrombosis; vascular death; and net adverse clinical event (a composite endpoint of major bleeding and MACE) were analyzed according to the "on-treatment" principle, using fully adjusted Cox and Fine-Gray regression models with doubly robust inverse probability of censoring weighted estimators. Results: Among 2,070 patients (mean age 63 years, 27% women, 62.5% ST-elevation MI), 1,035 were discharged on ticagrelor and clopidogrel, respectively. Ticagrelor-treated patients were younger and had few comorbidities, but high rates of medication non-compliance, compared with clopidogrel users. After comprehensive multivariate adjustments, ticagrelor did not increase the risk of major bleeding compared with clopidogrel [subhazard ratio, 1.40; 95% confidence interval (CI), 0.96-2.05], while proved superior in reducing MACE (hazard ratio 0.62; 95% CI, 0.43-0.90), vascular death (subhazard ratio, 0.71; 95% CI, 0.52-0.97) and definite/probable stent thrombosis (subhazard ratio, 0.54; 95% CI, 0.30-0.79); thereby resulting in a favorable net clinical benefit (hazard ratio 0.78; 95% CI, 0.60-0.98) compared with clopidogrel. Results from sensitivity analyses were consistent with those from the primary analysis, whereas those from the intention-to-treat (ITT) analysis went in the opposite direction. Conclusion: Among all-comers with ACS, ticagrelor did not significantly increase the risk of major bleeding, while resulting in a net clinical benefit compared with clopidogrel. Further research is warranted to confirm these findings in high bleeding risk populations. CREA-ARIAM Andalucía: (ClinicalTrials.gov Identifier: NCT02500290); Current pre-specified analysis (ClinicalTrials.gov Identifier: NCT04630288).

Factibilidad y resultados de un programa de rehabilitación cardiaca intensiva. Perspectiva del estudio aleatorizado MxM (Más por Menos) / Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Más por Menos) randomized trial

Introducción y objetivos: Los programas de rehabilitación cardiaca (PRC) engloban intervenciones encaminadas a mejorar el pronóstico de la enfermedad cardiovascular influyendo en la condición física, mental y social de los pacientes, pero no se conoce su duración óptima. Nuestro objetivo es comparar los resultados de un PRC estándar frente a otro intensivo más breve tras un síndrome coronario agudo, mediante el estudio Más por Menos. Métodos: Diseño prospectivo, aleatorizado, abierto, enmascarado a los evaluadores de eventos y multicéntrico (PROBE). Se aleatorizó a los pacientes al PRC estándar de 8 semanas u otro intensivo de 2 semanas con sesiones de refuerzo. Se realizó una visita final 12 meses después, tras la finalización del programa. Se evaluó: adherencia a la dieta, esfera psicológica, hábito tabáquico, tratamiento farmacológico, capacidad funcional, calidad de vida, parámetros cardiometabólicos y antropométricos, eventos cardiovasculares y mortalidad por cualquier causa durante el seguimiento. Resultados: Se analizó a 497 pacientes (media de edad, 57,8±10,0 años; el 87,3% varones; programa intensivo, n=262; estándar, n=235). Las características basales de ambos grupos eran similares. Al año, más del 93% había mejorado en al menos 1 MET el resultado de la ergometría. Además, la adherencia a la dieta mediterránea y la calidad de vida mejoraron significativamente con el PRC, sin diferencias significativas entre grupos. Los eventos cardiovasculares ocurrieron de manera similar en ambos grupos. Conclusiones: La PRC intensiva podría ser tan efectiva como la PRC estándar en lograr la adherencia a las medidas de prevención secundaria y ser una alternativa para algunos pacientes y centros. (AU)

Introduction and objectives: Cardiac rehabilitation programs (CRP) are a set of interventions to improve the prognosis of cardiovascular disease by influencing patients’ physical, mental, and social conditions. However, there are no studies evaluating the optimal duration of these programs. We aimed to compare the results of a standard vs a brief intensive CRP in patients after ST-segment elevation and non–ST-segment elevation acute coronary syndrome through the Más por Menos study (More Intensive Cardiac Rehabilitation Programs in Less Time). Methods: In this prospective, randomized, open, evaluator-blind for end-point, and multicenter trial (PROBE design), patients were randomly allocated to either standard 8-week CRP or intensive 2-week CRP with booster sessions. A final visit was performed 12 months later, after completion of the program. We assessed adherence to the Mediterranean diet, psychological status, smoking, drug therapy, functional capacity, quality of life, cardiometabolic and anthropometric parameters, cardiovascular events, and all-cause mortality during follow-up. Results: A total of 497 patients (mean age, 57.8±10.0 years; 87.3% men) were finally assessed (intensive: n=262; standard: n=235). Baseline characteristics were similar between the 2 groups. At 12 months, the results of treadmill ergometry improved by ≥ 1 MET in ≥ 93% of the patients. In addition, adherence to the Mediterranean diet and quality of life were significantly improved by CRP, with no significant differences between the groups. The occurrence of cardiovascular events was similar in the 2 groups. Conclusions: Intensive CRP could be as effective as standard CRP in achieving adherence to recommended secondary prevention measures after acute coronary syndrome and could be an alternative for some patients and centers. (AU)

Fondaparinux versus enoxaparin in the contemporary management of non-ST-elevation acute coronary syndromes. Insights from a multicenter registry.

BACKGROUND: Fondaparinux is thought to have the most favorable risk-benefit profile among all anticoagulants in non-ST-elevation acute coronary syndrome (NSTE-ACS). However, conflicting findings exist whether this holds true in current clinical practice. We aimed to assess the net clinical benefit of fondaparinux versus enoxaparin in the contemporary management of NSTE-ACS. METHODS: Analysis of prospective multicenter registry data of NSTE-ACS patients who received fondaparinux or enoxaparin from February 2015, through December 2017. Survival models within a competing risks framework including site-specific random effects, were used to assess the composite of clinically relevant bleedings and major adverse cardiovascular events at 30 days. RESULTS: Of 2094 patients, 1724 (82%) received enoxaparin and 370 (18%) fondaparinux. Both groups were comparable except for a lower prevalence of diabetes and renal impairment, and greater use of transradial approach in the fondaparinux group. Multivariate analysis revealed a net clinical benefit in favour of fondaparinux versus enoxaparin (Subhazard Ratio [SHR] 0.59; 95%CI 0.37-0.92), mainly driven by a reduction in bleeding (SHR 0.57; 95%CI 0.37-0.89). Exploratory analysis suggested greater reductions in bleeding with fondaparinux among patients undergoing transradial approach, revealing a significant interaction between treatment and vascular access on the multiplicative scale (Pinteraction = 0.0056), but not on an additive scale (P = 0.457). Propensity-score-matching analysis yielded similar results. CONCLUSIONS: In contemporary management of NSTE-ACS, fondaparinux seems to provide a favorable net clinical benefit compared with enoxaparin, primarily driven by a bleeding reduction. Effect modification on the safety profile of fondaparinux by the vascular access approach warrants further investigation.

Prevalence and clinical significance of totally occluded infarct-related arteries in patients with non-ST-segment elevation acute coronary syndromes.

Background Seemingly conflicting findings exist regarding the prognostic impact of totally occluded infarct-related arteries (oIRA) in non-ST elevation acute coronary syndromes (NSTE-ACS). Methods Retrospective analysis of prospective multicenter registry data comprising a single-center NSTE-ACS cohort, aimed at assessing the impact of occluded (TIMI flow 0/1) versus patent culprit vessels (pIRA, TIMI flow 2/3) on the composite endpoint of all-cause death and cardiogenic shock events at 30 days. Results Of 568 patients, 183 (32.5%) had oIRA. Male sex, refractory angina, ECG suggestive of multivessel or left main disease, and larger infarct sizes with inferior/posterolateral wall involvement, were identified as highly specific markers of oIRA. Successful culprit-lesion revascularization occurred more frequently in patent than in oIRA (90% vs. 96%; P = 0.013). Conversely, patients with oIRA more frequently achieved successful revascularization of concurrent non-IRAs including chronic total occlusions than did those with pIRA (28% vs. 3%; P = 0.0005). Multivariate analysis revealed neutral effects of oIRA on outcomes and identified incomplete revascularization as a powerful predictor of mortality. Moderation analysis revealed a significant interaction between completeness of revascularization and IRA patency, whereby among the incompletely revascularized patients, those with oIRA enjoyed a significant survival advantage over their counterparts with pIRA (11.8% vs. 28%, adjusted OR 0.34; 95% CI 0.10-0.73; Pinteraction = 0.012). Conclusions Approximately one third of NSTE-ACS patients in this cohort had oIRA. However, compared with pIRA, the occurrence of oIRA did not portend poor outcomes, likely resulting from the higher rate of incomplete revascularization and increased risk of subsequent mortality in patients with pIRA. These exploratory findings warrant further investigation.

Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Más por Menos) randomized trial.

INTRODUCTION AND OBJECTIVES: Cardiac rehabilitation programs (CRP) are a set of interventions to improve the prognosis of cardiovascular disease by influencing patients' physical, mental, and social conditions. However, there are no studies evaluating the optimal duration of these programs. We aimed to compare the results of a standard vs a brief intensive CRP in patients after ST-segment elevation and non-ST-segment elevation acute coronary syndrome through the Más por Menos study (More Intensive Cardiac Rehabilitation Programs in Less Time). METHODS: In this prospective, randomized, open, evaluator-blind for end-point, and multicenter trial (PROBE design), patients were randomly allocated to either standard 8-week CRP or intensive 2-week CRP with booster sessions. A final visit was performed 12 months later, after completion of the program. We assessed adherence to the Mediterranean diet, psychological status, smoking, drug therapy, functional capacity, quality of life, cardiometabolic and anthropometric parameters, cardiovascular events, and all-cause mortality during follow-up. RESULTS: A total of 497 patients (mean age, 57.8±10.0 years; 87.3% men) were finally assessed (intensive: n=262; standard: n=235). Baseline characteristics were similar between the 2 groups. At 12 months, the results of treadmill ergometry improved by ≥ 1 MET in ≥ 93% of the patients. In addition, adherence to the Mediterranean diet and quality of life were significantly improved by CRP, with no significant differences between the groups. The occurrence of cardiovascular events was similar in the 2 groups. CONCLUSIONS: Intensive CRP could be as effective as standard CRP in achieving adherence to recommended secondary prevention measures after acute coronary syndrome and could be an alternative for some patients and centers. Registered at ClinicalTrials.gov (Identifier: NCT02619422).

Hemopericardio en infarto agudo de miocardio fibrinolisado secundario a disección coronaria espontánea / Haemopericardium in a fibrinolysis in acute myocardial infarction secondary to a spontaneous coronary artery dissection

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