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. Eur Heart J. 2014 Aug 22, Breithardt G1, Baumgartner H2, Berkowitz SD3, Hellkamp AS4, Piccini JP4, Stevens SR4, Lokhnygina Y4, Patel MR4, Halperin JL5, Singer DE6, Hankey GJ7,Hacke W8, Becker RC4, Nessel CC9, Mahaffey KW10, Fox KA11, Califf RM12; for the ROCKET AF Steering Committee & Investigators.
- 1Department of Cardiovascular Medicine, Division of Electrophysiology, University Hospital Münster, Von-Esmarch-Strasse 117, Münster D-48149, Germany firstname.lastname@example.org.
- 2Department of Cardiovascular Medicine, Division of Adult Congenital and Valvular Heart Disease, University Hospital Münster, Münster, Germany.
- 3Bayer Healthcare Pharmaceuticals, L.P., Whippany, NJ, USA.
- 4Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
- 5The Cardiovascular Institute, Mount Sinai Medical Center, New York, NY, USA.
- 6Clinical Epidemiology Unit, General Medicine Division, Massachusetts General Hospital, and Harvard Medical School, Boston, MA, USA.
- 7School of Medicine and Pharmacology, The University of Western Australia, Perth, Australia.
- 8Ruprecht-Karls-University, Heidelberg, Germany.
- 9Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA.
- 10Department of Medicine, Stanford University, Stanford, CA, USA.
- 11University of Edinburgh, and Royal Infirmary of Edinburgh, Edinburgh, UK.
- 12Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC, USA.
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.
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.
© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.