Abstract 15879: Management of Major Bleeding Events in Patients Treated With Rivaroxaban Versus Warfarin: Results From the ROCKET AF Trial
Background: There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors and the extent to which specific or general measures may be required to manage bleeding.
Methods and Results: In ROCKET AF, 14,264 patients with nonvalvular AF were randomized to rivaroxaban or dose-adjusted warfarin; 779 patients experienced major bleeding. We analyzed characteristics, transfusions, pharmacologic management, and subsequent outcomes according to randomized treatment. The median CHADS2 and HASBLED scores were 3 (25th, 75th: 3, 4) and 3 (2, 4) in patients with and without a major bleed. The median numbers of transfused packed red blood cells per episode were similar in the rivaroxaban and warfarin arms (2 [2, 4] units in both arms). Very few transfusions of whole blood (n=14), platelets (n=10), or cryoprecipitate (n=2) were used. Transfusion of fresh frozen plasma was significantly less in the rivaroxaban arm (n=45 vs. n=81 units) after adjustment for covariates (OR 0.43 [95% CI 0.29, 0.66]; p<.0001). Prothrombin complex concentrates were administered less frequently in the rivaroxaban arm (n=4 [0.9%] vs. n=9 [2.2%]). Very few patients received factor VIIa, factor VIII, or factor IX within 1 day of major bleeding (rivaroxaban n=1, warfarin n=5). Outcomes after a major bleeding event, including stroke or non-CNS embolism and all-cause death (HR for rivaroxaban vs. warfarin 0.68 [95% CI 0.45, 1.04]) were similar (interaction p=0.99 and 0.11); however, significantly fewer intracranial and fatal bleeds occurred in the rivaroxaban arm.
Conclusions: In patients with nonvalvular AF at moderate-to-high risk of stroke, major bleeding in rivaroxaban patients did not require greater transfusion of fresh frozen plasma or coagulation factors compared with warfarin, and the use of specialist coagulation factors was rare. Adverse outcomes following major bleeding were similar in rivaroxaban- and warfarin-treated patients.
- © 2013 by American Heart Association, Inc.