ARISTOTLE

Apixaban for Reduction in Stroke and Other Thromboembolic Events in AF

Patient / Population Intervention / Exposure Comparison Outcome

In 18,201 patients with AF and ≥ 1 stroke risk factor, apixaban reduced stroke or systemic embolism, major bleeding and all-cause mortality compared with warfarin.

18,201

Design

Double-blind, double-dummy RCT

Endpoint

Stroke or systemic embolism

Relevance

Result1.27 %/yr vs 1.60 %/yr. Major bleed 2.13 % vs 3.09 %.

Granger CB, et al. N Engl J Med. 2011;365(11):981-992. 10.1056/NEJMoa1107039

Discussion & critique

Apixaban is the only NOAC superior on all three: stroke, bleed, mortality. Dose-reduction criteria (age ≥ 80, weight ≤ 60 kg, Cr ≥ 1.5) are often misapplied in practice.