Table 3.
Summary of efficacy and safety results in ROCKET AF and in subgroup analyses (event rate per 100 patient-years of follow-up; percentage of events per year)
| Study | Primary efficacy endpoint*
|
Principal safety endpoint†
|
||||||
|---|---|---|---|---|---|---|---|---|
| Rivaroxaban | Warfarin | HR (95% CI) | P-value | Rivaroxaban | Warfarin | HR (95% CI) | P-value | |
| ROCKET AF: per-protocol, as-treated study population for primary efficacy endpoint; safety, as-treated population for principal safety endpoint4 | ||||||||
| Overall | 1.7 | 2.2 | 0.79 (0.66–0.96) | <0.001 (for noninferiority) | 14.9 | 14.5 | 1.03 (0.96–1.11) | 0.44 |
| Renal function subgroups: per-protocol, as-treated study population for primary efficacy endpoint; safety, as-treated population for principal safety endpoint26 | ||||||||
| CrCl 30–49 mL/minute‡ | 2.32 | 2.77 | 0.84 (0.57–1.23) | 0.76§ | 17.82 | 18.28 | 0.98 (0.84–1.14) | 0.4496§ |
| CrCl ≥50 mL/minute | 1.57 | 2.00 | 0.78 (0.63–0.98) | 14.24 | 13.67 | 1.04 (0.96–1.13) | ||
| History of previous stroke or TIA: intent-to-treat population for primary efficacy endpoint; safety, as-treated population for principal safety endpoint27 | ||||||||
| No | 1.44 | 1.88 | 0.77 (0.58–1.01) | 0.23 | 16.69 | 15.19 | 1.10 (0.99–1.21) | 0.08 |
| Yes | 2.79 | 2.96 | 0.94 (0.77–1.16) | 13.31 | 13.87 | 0.96 (0.87–1.07) | ||
| VKA-naïve or VKA-experienced patients: intent-to-treat population for primary efficacy endpoint; safety, as-treated population for principal safety endpoint31 | ||||||||
| VKA-naïve | 2.32 | 2.87 | 0.81 (0.64–1.03) | 0.36 | 11.20|| | 12.87 | 0.84 (0.74–0.95) | 0.003 |
| VKA-experienced | 1.98 | 2.09 | 0.94 (0.75–1.18) | 14.73|| | 14.28 | 1.06 (0.96–1.17) | ||
| Patients with or without HF: intent-to-treat population for primary efficacy endpoint; safety, as-treated population for principal safety endpoint30 | ||||||||
| With HF | 1.90 | 2.09 | 0.91 (0.74–1.13) | 0.62 | 14.22 | 14.02 | 1.05 (0.95–1.15) | 0.99 |
| Without HF | 2.10 | 2.54 | 0.84 (0.65–1.09) | 16.12 | 15.35 | 1.05 (0.93–1.18) | ||
Notes:
Composite of stroke and systemic embolism
Composite of major and nonmajor clinically relevant bleeding
15 mg od
P-values are the same for CrCl 30–49 mL/minute and CrCl ≥50 mL/minute
Composite of major and nonmajor clinically relevant bleeding 30 days after randomization. Data from references 4, 26, 27 and 31. Copyright © 2013. Wolters Kluwer Health. Adapted with permission from van Diepen S, Hellkamp AS, Patel MR, et al. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013;6(4):740–747.30 Copyright © 2011. Fox KA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32(19):2387–2394, by permission of Oxford University Press, http://eurheartj.oxfordjournals.org/content/early/2011/08/26/eurheartj.ehr342.full. Permission must be obtained from Oxford University Press for any onwards reuse of the figure.26
Abbreviations: CI, confidence interval; CrCl, creatinine clearance; HF, heart failure; HR, hazard ratio; od, once daily; TIA, transient ischemic attack; VKA, vitamin K antagonist.