ImportanceTo our knowledge, no randomized clinical trial has compared the invasive and conservative strategies in frail, older patients with non–ST-segment elevation acute myocardial infarction (NSTEMI).ObjectiveTo compare outcomes of invasive and conservative strategies in frail, older patients with NSTEMI at 1 year.Design, Setting, and ParticipantsThis multicenter randomized clinical trial was conducted at 13 Spanish hospitals between July 7, 2017, and January 9, 2021, and included 167 older adult (≥70 years) patients with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. Data analysis was performed from April 2022 to June 2022.InterventionsPatients were randomized to routine invasive (coronary angiography and revascularization if feasible; n = 84) or conservative (medical treatment with coronary angiography for recurrent ischemia; n = 83) strategy.Main Outcomes and MeasuresThe primary end point was the number of days alive and out of the hospital (DAOH) from discharge to 1 year. The coprimary end point was the composite of cardiac death, reinfarction, or postdischarge revascularization.ResultsThe study was prematurely stopped due to the COVID-19 pandemic when 95% of the calculated sample size had been enrolled. Among the 167 patients included, the mean (SD) age was 86 (5) years, and mean (SD) Clinical Frailty Scale score was 5 (1). While not statistically different, DAOH were about 1 month (28 days; 95% CI, −7 to 62) greater for patients managed conservatively (312 days; 95% CI, 289 to 335) vs patients managed invasively (284 days; 95% CI, 255 to 311; P = .12). A sensitivity analysis stratified by sex did not show differences. In addition, we found no differences in all-cause mortality (hazard ratio, 1.45; 95% CI, 0.74-2.85; P = .28). There was a 28-day shorter survival in the invasive vs conservatively managed group (95% CI, −63 to 7 days; restricted mean survival time analysis). Noncardiac reasons accounted for 56% of the readmissions. There were no differences in the number of readmissions or days spent in the hospital after discharge between groups. Neither were there differences in the coprimary end point of ischemic cardiac events (subdistribution hazard ratio, 0.92; 95% CI, 0.54-1.57; P = .78).Conclusions and RelevanceIn this randomized clinical trial of NSTEMI in frail older patients, there was no benefit to a routine invasive strategy in DAOH during the first year. Based on these findings, a policy of medical management and watchful observation is recommended for older patients with frailty and NSTEMI.Trial RegistrationClinicalTrials.gov Identifier: NCT03208153
Background Bleeding risk scores have shown a limited predictive ability in elderly patients with acute coronary syndromes (ACS). No study explored the role of a comprehensive geriatric assessment to predict in-hospital bleeding in this clinical setting. Methods The prospective multicentre LONGEVO-SCA registry included 532 unselected patients with non-ST segment elevation ACS (NSTEACS) aged 80 years or older. Comorbidity (Charlson index), frailty (FRAIL scale), disability (Barthel index and Lawton–Brody index), cognitive status (Pfeiffer test) and nutritional risk (mini nutritional assessment-short form test) were assessed during hospitalization. CRUSADE score was prospectively calculated for each patient. In-hospital major bleeding was defined by the CRUSADE classification. The association between geriatric syndromes and in-hospital major bleeding was assessed by logistic regression method and the area under the receiver operating characteristic curves (AUC). Results Mean age was 84.3 years (SD 4.1), 61.7% male. Most patients had increased troponin levels (84%). Mean CRUSADE bleeding score was 41 (SD 13). A total of 416 patients (78%) underwent an invasive strategy, and major bleeding was observed in 37 cases (7%). The ability of the CRUSADE score for predicting major bleeding was modest (AUC 0.64). From all aging-related variables, only comorbidity (Charlson index) was independently associated with major bleeding (per point, odds ratio: 1.23, p = 0.021). The addition of comorbidity to CRUSADE score slightly improved the ability for predicting major bleeding (AUC: 0.68). Conclusion Comorbidity was associated with major bleeding in very elderly patients with NSTEACS. The contribution of frailty, disability or nutritional risk for predicting in-hospital major bleeding was marginal.
Aims Anemia is associated with poorer outcomes in patients with acute coronary syndromes (ACS), but the magnitude of this association in elderly patients remains poorly understood. No study has assessed the prognostic impact of anemia according to frailty status in this setting. Methods The LONGEVO-SCA registry included unselected ACS patients aged at least 80 years. A geriatric assessment was performed during hospitalization, including frailty assessment using the FRAIL scale. Anemia was defined by the WHO criteria. We evaluated the impact of anemia on 6-month mortality according to the presence of frailty. Results A total of 517 patients were assessed. Mean age was 84.3 years, and a total of 236 patients (45.6%) had anemia. Patients with anemia had a higher prevalence of comorbidities and higher prevalence of frailty (30.6 vs. 22.3%, P = 0.007). A total of 60 patients (12.1%) died at 6 months [40 with anemia (17.5%) and 20 without anemia (7.5%), P = 0.001]. Anemia was independently associated with mortality at 6 months in the whole cohort (hazard ratio 2.28, 95% CI 1.13–457, P = 0.021). The association of anemia and mortality was different according to frailty status, being significant in patients without frailty (hazard ratio 3.94, 95% CI 1.84–8.45, P = 0.001), but not in frail patients (hazard ratio 1.17, 95% CI 0.53–2.57, P = 0.705), (P value for interaction = 0.035). Conclusion A high proportion of elderly patients with ACS have anemia, leading to a worse prognosis in the whole cohort. The association between anemia and mortality was especially significant in robust patients, whereas the poorer prognosis in frail patients was not modified by the presence of anemia.
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