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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.
- Source :
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European heart journal [Eur Heart J] 2014 Dec 14; Vol. 35 (47), pp. 3377-85. Date of Electronic Publication: 2014 Aug 22. - Publication Year :
- 2014
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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.<br />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.<br />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.<br /> (© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Subjects :
- Aged
Aortic Valve Insufficiency mortality
Atrial Fibrillation complications
Atrial Fibrillation mortality
Factor Xa Inhibitors therapeutic use
Female
Hemorrhage chemically induced
Humans
Male
Mitral Valve Insufficiency mortality
Rivaroxaban
Stroke etiology
Stroke mortality
Stroke prevention & control
Treatment Outcome
Anticoagulants therapeutic use
Aortic Valve Insufficiency complications
Atrial Fibrillation drug therapy
Mitral Valve Insufficiency complications
Morpholines therapeutic use
Thiophenes therapeutic use
Warfarin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1522-9645
- Volume :
- 35
- Issue :
- 47
- Database :
- MEDLINE
- Journal :
- European heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 25148838
- Full Text :
- https://doi.org/10.1093/eurheartj/ehu305