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Evevident
Original paper
2011NEJMCardiology

ROCKET AF

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation

RCTAtrial fibrillation anticoagulation

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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.

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 / CI 95% CI 0.74-1.03 / p=<0.001 for noninferiority

Key results

  • Rivaroxaban was noninferior to warfarin for stroke or systemic embolism.
  • 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

When to cite

  • When comparing DOAC choices and discussing rivaroxaban evidence in nonvalvular AF.

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.

Related evidence

RE-LY - Similar QuestionARISTOTLE - Similar QuestionPAUSE - Context

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

Rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism.