• Jonathan P Piccini, Jyotsna Garg, Manesh R Patel, Yuliya Lokhnygina, Shaun G Goodman, Richard C Becker, Scott D Berkowitz, Günter Breithardt, Werner Hacke, Jonathan L Halperin, Graeme J Hankey, Christopher C Nessel, Kenneth W Mahaffey, Daniel E Singer, Robert M Califf, Keith A A Fox, and ROCKET AF Investigators.
• Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27710, USA jonathan.piccini@duke.edu.
• Eur. Heart J. 2014 Jul 21; 35 (28): 1873-80.

AimsThere are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors.Methods And ResultsUsing data from ROCKET AF, we analysed the management and outcomes of major bleeding overall and according to the randomized treatment. During a median follow-up of 1.9 years, 779 (5.5%) patients experienced major bleeding at a rate of 3.52 events/100 patient-years with a similar event rate in each arm (n = 395 rivaroxaban vs. n = 384 warfarin). The median number of transfused packed red blood cells (PRBC) per episode was similar in both arms [2 (25th, 75th: 2, 4) units]. Overall, few transfusions of whole blood (n = 14), platelets (n = 10), or cryoprecipitate (n = 2) were used. Transfusion of fresh frozen plasma (FFP) was significantly less in the rivaroxaban arm (n = 45 vs. n = 81 units) after adjustment for covariates [odds ratio (OR) 0.43 (95% CI 0.29-0.66); P < 0.0001]. Prothrombin complex concentrates (PCC) were administered less in the rivaroxaban arm (n = 4 vs. n = 9). Outcomes after major bleeding, including stroke or non-central nervous system embolism (4.7% rivaroxaban vs. 5.4% warfarin; HR 0.89; 95% CI 0.42-1.88) and all-cause death (20.4% rivaroxaban vs. 26.1% warfarin; HR 0.69, 95% CI 0.46-1.04) were similar in patients treated with rivaroxaban and warfarin (interaction P = 0.51 and 0.11).ConclusionAmong high-risk patients with atrial fibrillation who experienced major bleeding in ROCKET AF, the use of FFP and PCC was less among those allocated rivaroxaban compared with warfarin. However, use of PRBCs and outcomes after bleeding were similar among patients randomized to rivaroxaban or to warfarin.Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

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