Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial

ROCKET AF Steering Committee & Investigators, Günter Breithardt, Helmut Baumgartner, Scott D Berkowitz, Anne S Hellkamp, Jonathan P Piccini, Susanna R Stevens, Yuliya Lokhnygina, Manesh R Patel, Jonathan L Halperin, Daniel E Singer, Graeme J Hankey, Werner Hacke, Richard C Becker, Christopher C Nessel, Kenneth W Mahaffey, Keith A A Fox, Robert M Califf

Research output: Contribution to journalArticlepeer-review

Abstract

AIMS: We investigated clinical characteristics and outcomes of patients with significant valvular disease (SVD) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial.

METHODS AND RESULTS: ROCKET AF excluded patients with mitral stenosis or artificial valve prostheses. We used Cox regression to adjust comparisons for potential confounders. Among 14 171 patients, 2003 (14.1%) had SVD; they were older and had more comorbidities than patients without SVD. The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [2.01 vs. 2.43%; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.55-1.27] and without SVD (1.96 vs. 2.22%; HR 0.89, 95% CI 0.75-1.07; interaction P = 0.76). However, rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders. In intracranial haemorrhage, there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban.

CONCLUSIONS: Many patients with 'non-valvular atrial fibrillation' have significant valve lesions. Their risk of stroke is similar to that of patients without SVD after controlling for stroke risk factors. Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD; however, the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD. Atrial fibrillation patients with and without SVD experience the same stroke-preventive benefit of oral anticoagulants.

Original languageEnglish
Pages (from-to)3377-85
Number of pages9
JournalEuropean Heart Journal
Volume35
Issue number47
DOIs
Publication statusPublished - 14 Dec 2014

Keywords

  • Aged
  • Anticoagulants
  • Aortic Valve Insufficiency
  • Atrial Fibrillation
  • Factor Xa Inhibitors
  • Female
  • Hemorrhage
  • Humans
  • Male
  • Mitral Valve Insufficiency
  • Morpholines
  • Stroke
  • Thiophenes
  • Treatment Outcome
  • Warfarin

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