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Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).

Publication ,  Journal Article
Goodman, SG; Wojdyla, DM; Piccini, JP; White, HD; Paolini, JF; Nessel, CC; Berkowitz, SD; Mahaffey, KW; Patel, MR; Sherwood, MW; Becker, RC ...
Published in: J Am Coll Cardiol
March 11, 2014

OBJECTIVES: This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). BACKGROUND: The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. METHODS: The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. RESULTS: The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. CONCLUSIONS: Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 11, 2014

Volume

63

Issue

9

Start / End Page

891 / 900

Location

United States

Related Subject Headings

  • Warfarin
  • Vitamin K
  • Time Factors
  • Thiophenes
  • Stroke
  • Rivaroxaban
  • Risk Factors
  • Patient Safety
  • Morpholines
  • Middle Aged
 

Citation

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Goodman, S. G., Wojdyla, D. M., Piccini, J. P., White, H. D., Paolini, J. F., Nessel, C. C., … ROCKET AF Investigators. (2014). Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol, 63(9), 891–900. https://doi.org/10.1016/j.jacc.2013.11.013
Goodman, Shaun G., Daniel M. Wojdyla, Jonathan P. Piccini, Harvey D. White, John F. Paolini, Christopher C. Nessel, Scott D. Berkowitz, et al. “Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).J Am Coll Cardiol 63, no. 9 (March 11, 2014): 891–900. https://doi.org/10.1016/j.jacc.2013.11.013.
Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, Berkowitz SD, Mahaffey KW, Patel MR, Sherwood MW, Becker RC, Halperin JL, Hacke W, Singer DE, Hankey GJ, Breithardt G, Fox KAA, Califf RM, ROCKET AF Investigators. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol. 2014 Mar 11;63(9):891–900.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 11, 2014

Volume

63

Issue

9

Start / End Page

891 / 900

Location

United States

Related Subject Headings

  • Warfarin
  • Vitamin K
  • Time Factors
  • Thiophenes
  • Stroke
  • Rivaroxaban
  • Risk Factors
  • Patient Safety
  • Morpholines
  • Middle Aged