Abstract 245: Indirect Comparison of Efficacy and Safety data in Atrial Fibrillation patients treated with Apixaban (Aristotle study) versus Dabigatran (Rely study) based on Chads2 Score Stratification

Abstract

OBJECTIVES: In this analysis we performed indirect comparison of efficacy and safety of published data in atrial fibrillation (AF) patients stratified based on Chads2 score treated in RE-LY trial with Dabigatran (DAB) 150mg versus AF patients treated with Apixaban (APX) in ARISTOTLE study. METHODS: Primary efficacy and safety outcomes data for both cohorts were compared. WINPEPI (2011, version 11.15) epidemiological tool was used to compare the event rates ( safety and efficacy) per 100 patient year (100PY). RESULTS: For the primary end point of stroke or systemic embolism 0.7, 1.2 and 1.9 events in APX vs 0.65, 0.84 and 1.88 events in DAB occurred per 100PY (OR=1.07, 1.42, 1.01 respectively, all P statistically NS) in patients with Chads 2 score of 0-1, 2 and >=3; for safety end point of major bleed (any) 1.4, 2.3 and 2.9 events in APX vs 2.11, 3.04 and 4.85 events in DAB occurred per 100PY (OR=0.66 (P=0.055), 0.75 (P=0.093) and 0.59 (P =0.0005) in patients with Chads 2 score of 0-1, 2 and >=3. For both efficacy and safety parameters indirect comparison of the active comparator (warfarin) arms in both studies across the similar Chads 2 score categories did not exhibit statistically significant difference . CONCLUSIONS: This analysis of the published data suggests similar efficacy for both agents when used in AF patients across the Chad2 score categories, however there was a trend for a higher major bleeding risks ( Chads 2 score 0-1 and 2 ) and a statistically significantly higher bleeding event rate (Chads2 score >=3) with DAB.