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- Title
Invasive Treatment Strategy in Adults With Frailty and Non–ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of a Randomized Clinical Trial.
- Authors
Sanchis, Juan; Bueno, Héctor; García-Blas, Sergio; Alegre, Oriol; Martí, David; Martínez-Sellés, Manuel; Domínguez-Pérez, Laura; Díez-Villanueva, Pablo; Barrabés, Jose A.; Marín, Francisco; Villa, Adolfo; Sanmartín, Marcelo; Llibre, Cinta; Sionís, Alessandro; Carol, Antoni; Fernández-Cisnal, Agustín; Calvo, Elena; Morales, María José; Elízaga, Jaime; Gómez, Iván
- Abstract
Key Points: Question: Does a routine invasive strategy improve midterm outcomes in adults with frailty and acute non–ST-segment elevation myocardial infarction (NSTEMI)? Findings: In this secondary analysis of a randomized clinical trial of 167 patients with frailty and NSTEMI, a routine invasive strategy, when compared with a conservative strategy, did not reduce the number of days alive at a median follow-up of 1113 days. Invasive treatment was associated with shorter survival within the first year but more prolonged survival after the first year. Meaning: In patients with frailty and NSTEMI, an initial invasive strategy caused early harm followed by late benefit, resulting in a neutral effect on survival at 4 years. This extended follow-up of a randomized clinical trial investigates whether restricted mean survival time differs among patients with frailty who undergo intensive vs conservative treatment for acute non–ST-segment elevation myocardial infarction. 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
- Subjects
SPAIN; CONSERVATIVE treatment; NON-ST elevated myocardial infarction; SECONDARY analysis; RESEARCH funding; STATISTICAL hypothesis testing; FRAIL elderly; PATIENT readmissions; FISHER exact test; TREATMENT effectiveness; HOSPITALS; DESCRIPTIVE statistics; OPERATIVE surgery; KAPLAN-Meier estimator; CORONARY angiography; CONFIDENCE intervals; DATA analysis software; PATIENT aftercare; REGRESSION analysis; ADULTS
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe240809
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.0809