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

Publication ,  Journal Article
Piccini, JP; Garg, J; Patel, MR; Lokhnygina, Y; Goodman, SG; Becker, RC; Berkowitz, SD; Breithardt, G; Hacke, W; Halperin, JL; Hankey, GJ ...
Published in: Eur Heart J
July 21, 2014

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.

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Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

July 21, 2014

Volume

35

Issue

28

Start / End Page

1873 / 1880

Location

England

Related Subject Headings

  • Warfarin
  • Vitamin K
  • Treatment Outcome
  • Thiophenes
  • Stroke
  • Rivaroxaban
  • Plasma
  • Morpholines
  • Male
  • Humans
 

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Piccini, J. P., Garg, J., Patel, M. R., Lokhnygina, Y., Goodman, S. G., Becker, R. C., … ROCKET AF Investigators. (2014). Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. Eur Heart J, 35(28), 1873–1880. https://doi.org/10.1093/eurheartj/ehu083
Piccini, Jonathan P., Jyotsna Garg, Manesh R. Patel, Yuliya Lokhnygina, Shaun G. Goodman, Richard C. Becker, Scott D. Berkowitz, et al. “Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.Eur Heart J 35, no. 28 (July 21, 2014): 1873–80. https://doi.org/10.1093/eurheartj/ehu083.
Piccini JP, Garg J, Patel MR, Lokhnygina Y, Goodman SG, Becker RC, et al. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. Eur Heart J. 2014 Jul 21;35(28):1873–80.
Piccini, Jonathan P., et al. “Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.Eur Heart J, vol. 35, no. 28, July 2014, pp. 1873–80. Pubmed, doi:10.1093/eurheartj/ehu083.
Piccini JP, Garg J, Patel MR, Lokhnygina Y, Goodman SG, Becker RC, Berkowitz SD, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Mahaffey KW, Singer DE, Califf RM, Fox KAA, ROCKET AF Investigators. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. Eur Heart J. 2014 Jul 21;35(28):1873–1880.
Journal cover image

Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

July 21, 2014

Volume

35

Issue

28

Start / End Page

1873 / 1880

Location

England

Related Subject Headings

  • Warfarin
  • Vitamin K
  • Treatment Outcome
  • Thiophenes
  • Stroke
  • Rivaroxaban
  • Plasma
  • Morpholines
  • Male
  • Humans