| Resum: |
Does a routine invasive strategy improve midterm outcomes in adults with frailty and acute non-ST-segment elevation myocardial infarction (NSTEMI)? 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. 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. 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. To assess the outcomes of the MOSCA-FRAIL trial during extended follow-up. 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. 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. The primary end point was the difference in restricted mean survival time (RMST). Secondary end points included readmissions for any cause, considering recurrent readmissions. 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. 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. ClinicalTrials. gov Identifier:. |
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(Universitat de València)
