Format

Send to

Choose Destination
Eur Heart J. 2014 Jul 21;35(28):1873-80. doi: 10.1093/eurheartj/ehu083. Epub 2014 Mar 21.

Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.

Author information

1
Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27710, USA jonathan.piccini@duke.edu.
2
Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27710, USA.
3
Canadian Heart Research Centre and Terrence Donnelly Heart Centre, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Canada.
4
Division of Cardiovascular Health and Disease, University of Cincinnati, Cincinnati, OH.
5
Bayer HealthCare Pharmaceuticals, Montville, NJ, USA.
6
Hospital of the University of Münster, Münster, Germany.
7
Ruprecht-Karls-University, Heidelberg, Germany.
8
Cardiovascular Institute, Mount Sinai Medical Center, New York, NY, USA.
9
School of Medicine and Pharmacology, The University of Western Australia, Crawley, Australia.
10
Janssen Research and Development, Raritan, NJ, USA.
11
Stanford University School of Medicine, Stanford, CA, USA.
12
Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
13
Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC, USA.
14
University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, UK.

Abstract

AIMS:

There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors.

METHODS AND RESULTS:

Using 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).

CONCLUSION:

Among 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.

KEYWORDS:

Atrial fibrillation; Bleeding; Factor Xa inhibitor

PMID:
24658769
DOI:
10.1093/eurheartj/ehu083
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center