Περίληψη:
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.
Συγγραφείς:
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.
Λέξεις-κλειδιά:
dabigatran, aged; alanine aminotransferase blood level; anticoagulant therapy; article; bilirubin blood level; brain hemorrhage; cerebrovascular accident; controlled study; double blind procedure; drug dose comparison; dyspepsia; embolism; female; follow up; gastrointestinal hemorrhage; heart atrium fibrillation; human; long term care; major clinical study; male; multicenter study; observational study; priority journal; randomized controlled trial; side effect; systemic disease, atrial fibrillation; dabigatran; hemorrhage; stroke, Aged; Aged, 80 and over; Antithrombins; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Dose-Response Relationship, Drug; Embolism; Female; Follow-Up Studies; Hemorrhage; Hospitalization; Humans; Male; Middle Aged; Stroke; Treatment Outcome
