Abstract | OBJECTIVES: BACKGROUND: 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:
|
Authors | Shaun G Goodman, Daniel M Wojdyla, Jonathan P Piccini, Harvey D White, John F Paolini, Christopher C Nessel, Scott D Berkowitz, Kenneth W Mahaffey, Manesh R Patel, Matthew W Sherwood, Richard C Becker, Jonathan L Halperin, Werner Hacke, Daniel E Singer, Graeme J Hankey, Gunter Breithardt, Keith A A Fox, Robert M Califf, ROCKET AF Investigators |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 63
Issue 9
Pg. 891-900
(Mar 11 2014)
ISSN: 1558-3597 [Electronic] United States |
PMID | 24315894
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anticoagulants
- Factor Xa Inhibitors
- Morpholines
- Thiophenes
- Vitamin K
- Warfarin
- Rivaroxaban
|
Topics |
- Aged
- Anticoagulants
(administration & dosage)
- Atrial Fibrillation
(complications, drug therapy)
- Blood Pressure
- Embolism
(prevention & control)
- Factor Xa Inhibitors
- Female
- Hemorrhage
(etiology)
- Humans
- Male
- Middle Aged
- Morpholines
(administration & dosage)
- Patient Safety
- Risk Factors
- Rivaroxaban
- Stroke
(prevention & control)
- Thiophenes
(administration & dosage)
- Time Factors
- Vitamin K
(antagonists & inhibitors)
- Warfarin
(administration & dosage)
|