Abstract | AIMS: 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:
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Authors | 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, ROCKET AF Steering Committee & Investigators |
Journal | European heart journal
(Eur Heart J)
Vol. 35
Issue 47
Pg. 3377-85
(Dec 14 2014)
ISSN: 1522-9645 [Electronic] England |
PMID | 25148838
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology. |
Chemical References |
- Anticoagulants
- Factor Xa Inhibitors
- Morpholines
- Thiophenes
- Warfarin
- Rivaroxaban
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Topics |
- Aged
- Anticoagulants
(therapeutic use)
- Aortic Valve Insufficiency
(complications, mortality)
- Atrial Fibrillation
(complications, drug therapy, mortality)
- Factor Xa Inhibitors
(therapeutic use)
- Female
- Hemorrhage
(chemically induced)
- Humans
- Male
- Mitral Valve Insufficiency
(complications, mortality)
- Morpholines
(therapeutic use)
- Rivaroxaban
- Stroke
(etiology, mortality, prevention & control)
- Thiophenes
(therapeutic use)
- Treatment Outcome
- Warfarin
(therapeutic use)
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