| Autor: |
Connolly, S.J. Wallentin, L. Ezekowitz, M.D. Eikelboom, J. Oldgren, J. Reilly, P.A. Brueckmann, M. Pogue, J. Alings, M. Amerena, J.V. Avezum, A. Baumgartner, I. Budaj, A.J. Chen, J.-H. Dans, A.L. Darius, H. Di Pasquale, G. Ferreira, J. Flaker, G.C. Flather, M.D. Franzosi, M.G. Golitsyn, S.P. Halon, D.A. Heidbuchel, H. Hohnloser, S.H. Huber, K. Jansky, P. Kamensky, G. Keltai, M. Kim, S.S. Lau, C.-P. Le Heuzey, J.-Y. Lewis, B.S. Liu, L. Nanas, J. Omar, R. Pais, P. Pedersen, K.E. Piegas, L.S. Raev, D. Smith, P.J. Talajic, M. Tan, R.S. Tanomsup, S. Toivonen, L. Vinereanu, D. Xavier, D. Zhu, J. Wang, S.Q. Duffy, C.O. Themeles, E. Yusuf, S. |
| Jazyk: |
angličtina |
| Rok vydání: |
2013 |
| ISSN: |
0080-8067 |
| Popis: |
BACKGROUND - : During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. METHODS AND RESULTS - : Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04-1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y. CONCLUSIONS - : During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death. CLINICAL TRIAL REGISTRATION - : URL: http://www.clinicaltrials.gov. Unique identifier: NCT00808067. © 2013 American Heart Association, Inc. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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