Efficacy and Safety of Rivaroxaban in Patients with Heart Failure and Non-Valvular Atrial Fibrillation: Insights from ROCKET AF

Sean van Diepen, Anne S Hellkamp, Manesh R Patel, Richard C Becker, Günter Breithardt, Werner Hacke, Jonathan L Halperin, Graeme J Hankey, Christopher C Nessel, Daniel E Singer, Scott D Berkowitz, Robert M Califf, Keith A A Fox, Kenneth W Mahaffey

Research output: Contribution to journalArticlepeer-review

Abstract

Background: In ROCKET AF, rivaroxaban was non-inferior to warfarin for the prevention of stroke and systemic embolic events and significantly reduced intracranial bleeding in patients with non-valvular atrial fibrillation (AF). We explore the safety and efficacy of rivaroxaban in patients with heart failure (HF).

Methods and Results: A total of 9033 (63.7%) patients had HF. The primary efficacy analysis was rates of stroke or systemic embolism (per 100 patient-years) by intention to treat. The safety outcomes were major or nonmajor clinically relevant bleeding and hemorrhagic stroke during treatment. Patients with HF were younger (72 versus 74 years), more likely to have persistent atrial fibrillation (83.0% versus 77.6%), and had higher mean CHADS2 scores (3.7 versus 3.1). The efficacy of rivaroxaban compared with warfarin was similar in patients with HF (1.90 versus 2.09) and without HF (2.10 versus 2.54; P-interaction=0.62). The risk of major or nonmajor clinically relevant bleeding with rivaroxaban was similar to warfarin in patients with HF (14.22 versus 14.02) and without HF (16.12 versus 15.35; P-interaction=0.99). A reduction in hemorrhagic stroke was observed with rivaroxaban in patients with HF as in the overall trial (adjusted hazard ratio, 0.38; 95% confidence interval, 0.19–0.76; P-interaction=0.067). Among patients with HF, the efficacy of rivaroxaban was similar, irrespective of ejection fraction <40 or ≥40% (P-interaction=0.38), New York Heart Association class I-II versus III-IV (P-interaction=0.68), HF preserved or reduced ejection fraction (P-interaction=0.35), or CHADS2 score 2 versus ≥3 (P-interaction=0.48).

Conclusions: Treatment-related outcomes were similar in patients with and without HF and across HF subgroups. These findings support the use of rivaroxaban as an alternative to warfarin in patients with atrial fibrillation and HF.
Original languageEnglish
JournalCirculation: Heart failure
DOIs
Publication statusPublished - 30 May 2013

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