In the ARISTOTLE trial comparing apixaban with warfarin in pts with AF, apixaban 2.5mg was used in pts with 2 or more dose reduction (DR) criteria: age ≥80 years, creatinine ≥1.5mg/dL, weight ≤60kg. Pts assigned 2.5mg of apixaban vs. warfarin (n=831) had similar reductions in stroke/SE and major bleeding to pts assigned 5.0 mg of apixaban vs. warfarin (n=17,370).
We compared pts assigned to apixaban 5.0mg or warfarin, with 1 of 3 DR criteria with pts with 0 of 3 criteria. Stroke/SE and major bleeding rates, hazard ratios and 95% CIs were evaluated, and interactions between treatment and the presence of 1 vs. 0 DR criteria were determined.
Among pts assigned 5.0mg of apixaban or warfarin, 4046 (23%) had one DR criteria. These pts were older (77 vs. 68 years), of lighter weight (86 vs . 70 kg), and had worse renal function (creatinine 1.00 vs. 1.07 mL/min) than pts with no DR criteria. Pts with one DR criteria had more stroke/SE and major bleeding but had similar benefits of apixaban vs. warfarin on stroke/SE (p=0.41) and major bleeding (p=0.65). Similar patterns were seen for individual DR criteria.
Pts with isolated advanced age (≥80 years), low body weight (≤60kg), or renal dysfunction (Cr≥1.5mg/dL) had slightly more stroke/SE and significantly more major bleeding but similar benefits with apixaban 5.0mg BID compared with warfarin to pts with none of these characteristics. Apixaban 5.0mg BID is a safe and efficacious dose for these pts.
© 2015 Published by Elsevier Inc.