Impact of Frailty on the Benefits of Dual Pathway Inhibition for the Secondary Prevention of Cardiovascular Events in the COMPASS Randomised Trial.

Autor: Leong DP; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada. Electronic address: darryl.leong@phri.ca., Bosch J; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada; Department of Rehabilitation Sciences, McMaster University, Hamilton, Canada., Bhatt DL; Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Avezum A; International Research Center, Hospital Alemão Oswaldo Cruz, São Paolo, São Paolo, Brazil., Yuan F; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada., Yusuf S; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada., Eikelboom JW; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada.
Jazyk: angličtina
Zdroj: The Canadian journal of cardiology [Can J Cardiol] 2024 Jun 22. Date of Electronic Publication: 2024 Jun 22.
DOI: 10.1016/j.cjca.2024.06.017
Abstrakt: Background: Individuals with frailty are at higher risk of adverse cardiovascular outcomes and bleeding. The objective of this study was to determine whether the effects of 2.5 mg rivaroxaban twice daily in addition to low-dose aspirin are similar among frail compared with nonfrail patients with chronic atherosclerotic vascular disease.
Methods: In the COMPASS trial (NCT01776424), patients with chronic atherosclerotic vascular disease were randomised to receive 100 mg aspirin daily, 100 mg aspirin daily plus 2.5 mg rivaroxaban twice daily, or 5 mg rivaroxaban twice daily. In this post hoc analysis, frailty was evaluated by constructing a cumulative deficit index from 37 diseases, signs, and symptoms. The frailty index for each participant was calculated as the proportion of the 37 deficits exhibited, with values > 0.2 considered to be frail. The primary outcome was the composite of cardiovascular death, myocardial infarction, or stroke. Hazard ratios (HRs) and 95% confidence intervals (CIs) are reported.
Results: Frailty was present in 13% of the trial population. In nonfrail individuals, adding 2.5 mg rivaroxaban twice daily to aspirin reduced the primary outcome (HR 0.69, 95% CI 0.59-0.80) and mortality (HR 0.75, 95% CI 0.63-0.90), but increased major bleeding (HR 1.87, 95% CI 1.51-2.31); Among participants with frailty, its effects on the primary outcome (HR 1.06, 95% CI 0.79-1.42), mortality (HR 1.08, 0.80-1.46), and major bleeding (HR 1.10, 95% CI 0.71-1.70) were not evident (respective interaction P values 0.011, 0.049, and 0.032).
Conclusions: In adults with chronic atherosclerotic vascular disease, the benefit of adding 2.5 mg rivaroxaban twice daily to aspirin was not evident in patients with frailty.
Clinical Trial Registration: NCT01776424.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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