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)

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• 作者：Shaun G. Goodman ; MD ; MSc^&lowast ; ; ^{goodmans@chrc.net" class="auth_mail} ; Daniel M. Wojdyla ; MS^&dagger ; ; Jonathan P. Piccini ; MD^&dagger ; ; Harvey D. White ; MB ; ChB ; DSc^&Dagger ; ; John F. Paolini ; MD ; PhD^§ ; ; Christopher C. Nessel ; MD^鈥?/sup> ; Scott D. Berkowitz ; MD^§ ; ; Kenneth W. Mahaffey ; MD^&dagger ; ; Manesh R. Patel ; MD^&dagger ; ; Matthew W. Sherwood ; MD^&dagger ; ; Richard C. Becker ; MD^&dagger ; ; Jonathan L. Halperin ; MD^¶ ; ; Werner Hacke ; MD^# ; Daniel E. Singer ; MD^&lowast ; &lowast ; ; Graeme J. Hankey ; MD^&dagger ; &dagger ; ; Gunter Breithardt ; MD^&Dagger ; &Dagger ; ; Keith A.A. Fox ; MB ; ChB^§ ; § ; ; Robert M. Califf ; MD^{鈥栤€?/sup>} ; for the ROCKET AF Investigators
• 关键词：anticoagulants ; atrial fibrillation ; hemorrhage
• 刊名：Journal of the American College of Cardiology
• 出版年：11 March, 2014
• 年：2014
• 卷：63
• 期：9
• 页码：891-900
• 全文大小：607 K

文摘

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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,聽鈮?5 years; p_interaction聽= 0.59). Compared with those without (n聽= 13,455), patients with a major bleed (n聽= 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)聽鈮?0 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聽<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: )