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Dabigatran Versus Warfarin Effects on Ischemic and Hemorrhagic Strokes and Bleeding in Asians and Non-Asians With Atrial Fibrillation
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2013 (English)In: Stroke, ISSN 0039-2499, E-ISSN 1524-4628, Vol. 44, no 7, 1891-+ p.Article in journal (Refereed) Published
Abstract [en]

Background and Purpose-Intracranial hemorrhage rates are higher in Asians than non-Asians, especially in patients receiving warfarin. This randomized evaluation of long-term anticoagulation therapy subgroup analysis assessed dabigatran etexilate (DE) and warfarin effects on stroke and bleeding rates in patients from Asian and non-Asian countries. Methods-There were 2782 patients (15%) from 10 Asian countries and 15 331 patients from 34 non-Asian countries. A Cox regression model, with terms for treatment, region, and their interaction was used. Results-Rates of stroke or systemic embolism in Asians were 3.06% per year on warfarin, 2.50% per year on DE 110 mg BID (DE 110), and 1.39% per year on DE 150 mg BID (DE 150); in non-Asians, the rates were 1.48%, 1.37%, and 1.06% per year with no significant treatment-by-region interactions. Hemorrhagic stroke on warfarin occurred more often in Asians than non-Asians (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.3-4.7; P=0.007), with significant reductions for DE compared with warfarin in both Asian (DE 110 versus warfarin HR, 0.15; 95% CI, 0.03-0.66 and DE 150 versus warfarin HR, 0.22; 95% CI, 0.06-0.77) and non-Asian (DE 110 versus warfarin HR, 0.37; 95% CI, 0.19-0.72 and DE 150 versus warfarin HR, 0.28; 95% CI, 0.13-0.58) patients. Major bleeding rates in Asians were significantly lower on DE (both doses) than warfarin (warfarin 3.82% per year, DE 110 2.22% per year, and DE 150 2.17% per year). Conclusions-Hemorrhagic stroke rates were higher on warfarin in Asians versus non-Asians, despite similar blood pressure, younger age, and lower international normalized ratio values. Hemorrhagic strokes were significantly reduced by DE in both Asians and non-Asians. DE benefits were consistent across Asian and non-Asian subgroups.

Place, publisher, year, edition, pages
2013. Vol. 44, no 7, 1891-+ p.
Keyword [en]
Asia, atrial fibrillation, bleeding, dabigatran, intracranial hemorrhage, RE-LY, warfarin
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-219883DOI: 10.1161/STROKEAHA.113.000990ISI: 000330527500028OAI: oai:DiVA.org:uu-219883DiVA: diva2:703658
Available from: 2014-03-07 Created: 2014-03-06 Last updated: 2014-03-07Bibliographically approved

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Wallentin, Lars
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UCR-Uppsala Clinical Research CenterDepartment of Medical Sciences
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