STROKE AND BLEEDING OUTCOMES WITH APIXABAN VERSUS WARFARIN IN PATIENTS WITH HIGH CREATININE, LOW BODY WEIGHT OR HIGH AGE RECEIVING STANDARD DOSE APIXABAN FOR STROKE PREVENTION IN ATRIAL FIBRILLATION

Abstract

BACKGROUND: 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 (n1⁄4831) had similar reductions in stroke/SE and major bleeding to pts assigned 5.0 mg of apixaban vs. warfarin (n1⁄417,370). METHODS: 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. RESULTS: 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 (p1⁄40.41) and major bleeding (p1⁄40.65). Similar patterns were seen for individual DR criteria. CONCLUSION: 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. BMS/Pfizer