2026-06-14T00:34:50Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/204992024-09-27T09:33:29Zcom_20.500.12105_19604com_20.500.12105_2051col_20.500.12105_19605

00925njm 22002777a 4500 dc Sanchis, Juan author Bueno, Hector author García-Blas, Sergio author Alegre, Oriol author Martí, David author Martínez-Sellés, Manuel author Domínguez-Pérez, Laura author Díez-Villanueva, Pablo author Barrabés, Jose A author Marín, Francisco author Villa, Adolfo author Sanmartín, Marcelo author Llibre, Cinta author Sionís, Alessandro author Carol, Antoni author Fernández-Cisnal, Agustín author Calvo, Elena author Morales, María José author Elízaga, Jaime author Gómez, Iván author Alfonso, Fernando author García Del Blanco, Bruno author Formiga, Francesc author Núñez, Eduardo author Núñez, Julio author Ariza-Solé, Albert author 2024-03-04 IMPORTANCE The MOSCA-FRAIL randomized clinical trial compared invasive and conservative treatment strategies in patients with frailty with non-ST-segment elevation myocardial infarction (NSTEMI). It showed no differences in the number of days alive and out of the hospital at 1 year. OBJECTIVE To assess the outcomes of the MOSCA-FRAIL trial during extended follow-up. DESIGN, SETTING, AND PARTICIPANTS The MOSCA-FRAIL randomized clinical trial was conducted at 13 hospitals in Spain between July 7, 2017, and January 9, 2021, and included 167 adults (aged ≥70 years) with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. In this preplanned secondary analysis, follow-up was extended to January 31, 2023. Data analysis was performed from April 5 to 29, 2023, using the intention-to-treat principle. INTERVENTIONS Patients were randomized to a routine invasive (coronary angiography and revascularization if feasible [n = 84]) or a conservative (medical treatment with coronary angiography only if recurrent ischemia [n = 83]) strategy. MAIN OUTCOMES AND MEASURES The primary end point was the difference in restricted mean survival time (RMST). Secondary end points included readmissions for any cause, considering recurrent readmissions. RESULTS Among the 167 patients included in the analysis, the mean (SD) age was 86 (5) years; 79 (47.3%) were men and 88 (52.7%) were women. A total of 93 deaths and 367 readmissions accrued. The RMST for all-cause death over the entire follow-up was 3.13 (95% CI, 2.72-3.60) years in the invasive and 3.06 (95% CI, 2.84-3.32) years in the conservative treatment groups. The RMST analysis showed inconclusive differences in survival time (invasive minus conservative difference, 28 [95% CI, -188 to 230] days). Patients under invasive treatment tended to have shorter survival in the first year (-28 [95% CI, -63 to 7] days), which improved after the first year (192 [95% CI, 90-230] days). Kaplan-Meier mortality curves intersected, displaying higher mortality to 1 year in the invasive group that shifted to a late benefit (landmark analysis hazard ratio, 0.58 [95% CI, 0.33-0.99]; P = .045). Early harm was more evident in the subgroup with a Clinical Frailty Scale score greater than 4. No differences were found for the secondary end points. CONCLUSIONS AND RELEVANCE In this extended follow-up of a randomized clinical trial of patients with frailty and NSTEMI, an invasive treatment strategy did not improve outcomes at a median follow-up of 1113 (IQR, 443-1441) days. However, a differential distribution of deaths was observed, with early harm followed by later benefit. The phenomenon of depletion of susceptible patients may be responsible for this behavior. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03208153. JAMA Netw Open. 2024 Mar 4;7(3):e240809. 10.1001/jamanetworkopen.2024.0809 2574-3805 JAMA network open 38446482 http://hdl.handle.net/20.500.12105/20499 Invasive Treatment Strategy in Adults With Frailty and Non-ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of a Randomized Clinical Trial.