What is the clinical evidence from this study?

Study design: RCT. Population: Nonvalvular atrial fibrillation (n=14264). Intervention: Rivaroxaban vs. Warfarin (dose-adjusted). Primary outcome: Composite of stroke (ischemic or hemorrhagic) and systemic embolism (HR 0.79, 95% CI 0.66-0.96, p=<0.001).

What does this research mean for the field?

Rivaroxaban is noninferior to warfarin for the prevention of stroke or systemic embolism in patients with atrial fibrillation. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

August 10, 2011Open Access

Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation

Q: What are the key findings of this study?

Rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism, with a hazard ratio of 0.79 (95% CI, 0.66 to 0.96).

Q: What does this research mean for the field?

Rivaroxaban is noninferior to warfarin for the prevention of stroke or systemic embolism in patients with atrial fibrillation. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Key Result

Rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism, with a hazard ratio of 0.79 (95% CI, 0.66 to 0.96).

Study Design

Type

RCT

Randomization

Central computerized randomization

Blinding

Double-blind

Multicenter

Yes

Structured PICO

Does rivaroxaban prevent stroke or systemic embolism compared to warfarin in patients with nonvalvular atrial fibrillation?

Population

Patients with nonvalvular atrial fibrillation

Intervention

Rivaroxaban

Comparator

Warfarin

Outcome

Stroke or systemic embolismhard clinical

Rivaroxaban is a noninferior alternative to warfarin for stroke prevention in nonvalvular atrial fibrillation, offering a lower risk of intracranial and fatal bleeding.

Limitations

The study included a high proportion of patients with prior stroke or other risk factors, which may affect generalizability.

Abstract

In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson ROCKET AF ClinicalTrials.gov number, NCT00403767.).

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Discussion

Authors

Manesh R. Patel

Kenneth W. Mahaffey

Jyotsna Garg

Journals

New England Journal of Medicine

Actions

Institutions

Harvard University

Massachusetts General Hospital

Duke University

References and Citations

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Discussion

Cite this study

Patel et al. (Wed,) conducted a rct in Nonvalvular atrial fibrillation (n=14,264). Rivaroxaban vs. Warfarin (dose-adjusted) was evaluated on Composite of stroke (ischemic or hemorrhagic) and systemic embolism (HR 0.79, 95% CI 0.66-0.96, p=<0.001). Rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism, with a hazard ratio of 0.79 (95% CI, 0.66 to 0.96).

www.synapsesocial.com/papers/69813150ce4d1f8e18d4e860 — DOI: https://doi.org/10.1056/nejmoa1009638

Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation

Key Result

Study Design

Structured PICO

Limitations

Abstract

Citation Network

Connected Papers

Discussion

Authors

Journals

Actions

Institutions

References and Citations

Citation Network

Connected Papers

Discussion

Cite this study