Table S1.
Primary efficacy results for ROCKET AF
| Study population and analysis period | Median follow-up (days) | Rivaroxaban
|
Warfarin
|
Hazard ratio (95% CI)b |
P-value
|
|||
|---|---|---|---|---|---|---|---|---|
| na | Event rate (%/year) | na | Event rate (%/year) | Noninferiority | Superiority | |||
| Per protocol on treatment | 590 | 6,958 | 1.7 | 7,004 | 2.2 | 0.79 (0.66–0.96) | <0.001 | – |
| Safety on treatmentc | 590 | 7,061 | 1.7 | 7,082 | 2.2 | 0.79 (0.65–0.95) | – | 0.02 |
| Intention-to-treatd | 707 | 7,081 | 2.1 | 7,090 | 2.4 | 0.88 (0.75–1.03) | <0.001 | 0.12 |
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.
Number of patients;
hazard ratio is for rivaroxaban versus warfarin;
safety population included all patients who received at least one dose of study medication; on-treatment analyses evaluated all events occurring while patients were receiving study medication or within 2 days of permanent discontinuation;
intention-to-treat follow-up was until notification of study termination. ROCKET AF (ClinicalTrials.gov: NCT00403767).
Abbreviations: CI, confidence interval; 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.