Table S2.
Rates of bleeding outcomes in ROCKET AF
| Outcome | Rivaroxaban
|
Warfarin
|
Hazard ratio (95% CI)a | P-value | ||
|---|---|---|---|---|---|---|
| Events n (%) | Event rate (%/year) | Events n (%) | Event rate (%/year) | |||
| Principal safety outcome (major + nonmajor clinically relevant bleeding) | 1,475 (20.7) | 14.9 | 1,449 (20.3) | 14.5 | 1.03 (0.96–1.11) | 0.44 |
| Major bleeding | ||||||
| Any | 395 (5.6) | 3.6 | 386 (5.4) | 3.4 | 1.04 (0.90–1.20) | 0.58 |
| Decrease in Hb ≥2 g/dL | 305 (4.3) | 2.8 | 254 (3.6) | 2.3 | 1.22 (1.03–1.44) | 0.02 |
| Transfusion | 183 (2.6) | 1.6 | 149 (2.1) | 1.3 | 1.25 (1.01–1.55) | 0.04 |
| Critical bleedingb | 91 (1.3) | 0.8 | 133 (1.9) | 1.2 | 0.69 (0.53–0.91) | 0.007 |
| Fatal bleeding | 27 (0.4) | 0.2 | 55 (0.8) | 0.5 | 0.50 (0.31–0.79) | 0.003 |
| Intracranial hemorrhage | 55 (0.8) | 0.5 | 84 (1.2) | 0.7 | 0.67 (0.47–0.93) | 0.02 |
Notes: From Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883–891.1 Copyright © 2011 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
Hazard ratio is for rivaroxaban versus warfarin;
critical organ bleeding refers to bleeding in intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular (with compartment syndrome), or retroperitoneal locations. ROCKET AF (ClinicalTrials.gov: NCT00403767).
Abbreviations: CI, confidence interval; Hb, hemoglobin; 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.