Invasive Treatment Strategy in Adults With Frailty and Non–ST-Segment Elevation Myocardial Infarction
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 , Alfonso Fernando , García del Blanco Bruno , Formiga Francesc , Núñez Eduardo , Núñez Julio , Ariza-Solé Albert 
Published: March 2024

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