ROCKET AF
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
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Overview
Rivaroxaban was noninferior to warfarin for stroke prevention in higher-risk nonvalvular AF.
Clinical takeaway
ROCKET AF supports rivaroxaban as a once-daily DOAC option for nonvalvular AF, with less intracranial/fatal bleeding but more GI bleeding than warfarin.
Key result
Stroke or systemic embolism was noninferior with rivaroxaban versus warfarin (per-protocol HR 0.79; 95% CI 0.66-0.96; ITT HR 0.88; 95% CI 0.74-1.03, not superior).
Practice impact
Helped establish DOAC-first anticoagulation for eligible patients with nonvalvular AF.
Evidence
Study design
Randomized, double-blind, double-dummy, noninferiority trial.
Enrollment
14,264
Follow-up
Median about 1.9 years.
Geography
Multinational
Clinical question
Is rivaroxaban noninferior to warfarin for preventing stroke or systemic embolism in nonvalvular atrial fibrillation?
Population
- Patients with nonvalvular atrial fibrillation at moderate-to-high risk of stroke.
Intervention
Rivaroxaban 20 mg daily, dose-adjusted for renal function.
Comparator
Dose-adjusted warfarin.
Primary outcome
Stroke or systemic embolism.
Rivaroxaban was noninferior to warfarin for prevention of stroke or systemic embolism.
Hazard ratio / 0.88 / 95% CI 0.74-1.03 / p<0.001
Key results
- Rivaroxaban was noninferior to warfarin for stroke or systemic embolism in the per-protocol primary analysis: 1.7%/yr vs 2.2%/yr; HR 0.79; 95% CI 0.66-0.96; p<0.001 for noninferiority.
- Intention-to-treat: 2.1%/yr vs 2.4%/yr; HR 0.88; 95% CI 0.74-1.03; p<0.001 for noninferiority; p=0.12 for superiority.
- Major and clinically relevant nonmajor bleeding were similar overall.
- Intracranial and fatal bleeding were lower with rivaroxaban, while gastrointestinal bleeding was higher.
Harms
- Gastrointestinal bleeding was more common with rivaroxaban.
- As with all anticoagulants, bleeding risk and renal dosing are central.
Clinical Use
Practice impact
- Completed a major part of the DOAC evidence base for AF stroke prevention.
Applicability
- Nonvalvular AF patients who need anticoagulation and do not have contraindications to DOAC therapy.
Limitations
- Warfarin time-in-therapeutic range was modest.
- The population had relatively high baseline stroke risk compared with some AF trials.
Common misinterpretations
- Noninferiority to warfarin does not remove the need to dose-adjust for renal function or assess bleeding risk.
Citation
Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891. doi:10.1056/NEJMoa1009638
In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism.
- PMID
- 21830957