@article{2998977, title = "Dabigatran etexilate for secondary stroke prevention: The first year experience from a multicenter short-term registry", author = "Tsivgoulis, G. and Krogias, C. and Sands, K.A. and Sharma, V.K. and Katsanos, A.H. and Vadikolias, K. and Heliopoulos, I. and Mitsoglou, A. and Giannopoulos, S. and Piperidou, C. and Voumvourakis, K. and Alexandrov, A.V. and Papageorgiou, S.G. and Liantinioti, C. and Athanasiadis, D.", journal = "Therapeutic Advances in Neurological Disorders", year = "2014", volume = "7", number = "3", pages = "155-161", issn = "1756-2856, 1756-2864", doi = "10.1177/1756285614528064", keywords = "dabigatran etexilate; warfarin, aged; anticoagulant therapy; article; bloating; brain hemorrhage; brain ischemia; cerebrovascular accident; CHADS2 score; drug cost; drug efficacy; drug safety; drug substitution; drug withdrawal; dyspepsia; embolism; embolism prevention; female; flatulence; follow up; gastrointestinal hemorrhage; heart atrium fibrillation; heart infarction; hematuria; human; length of stay; major clinical study; male; medical society; medication compliance; multicenter study; patient compliance; pilot study; priority journal; prospective study; rectum hemorrhage; secondary prevention; systemic embolism; tertiary health care; transient ischemic attack; treatment outcome", abstract = "Background: There are growing concerns for the side effects of dabigatran etexilate (dabigatran), including higher incidence of dyspepsia and gastrointestinal bleeding. We conducted a multicenter early implementation study to prospectively evaluate the safety, efficacy and adherence to dabigatran for secondary stroke prevention. Methods: Consecutive atrial fibrillation (AF) patients with ischemic stroke (IS) or transient ischemic attack (TIA) received dabigatran for secondary stroke prevention during their hospital stay according to American Heart Association recommendations at five tertiary care stroke centers. The study population was prospectively followed and outcomes were documented. The primary and secondary safety outcomes were major hemorrhage and all other bleeding events respectively defined according to RE-LY trial methodology. Results: A total of 78 AF patients (mean age 71 ± 9years; 54% men; 81% IS, 19% TIA; median CHADS2 (Congestive heart failure, Hypertension, diabetes mellitus, age >75 years, prior stroke or TIA); range 2-5) score 4 were treated with dabigatran [(110mg bid (74%); 150mg bid (26%)]. During a mean follow-up period of 7 ± 5 months (range 1-18) we documented no cases of IS, TIA, intracranial hemorrhage, systemic embolism or myocardial infarction in AF patients treated with dabigatran. There were two (2.6%) major bleeding events (lower gastrointestinal bleeding) and two (2.6%) minor bleedings [hematuria (n = 1) and rectal bleeding (n = 1)]. Dabigatran was discontinued in 26% of the study population with high cost being the most common reason for discontinuation (50%). Discussion: Our pilot data indicate that dabigatran appears to be safe for secondary stroke prevention during the first year of implementation of this therapy. However, high cost may limit the long-term treatment of AF patients with dabigatran, leading to early discontinuation. © 2014, SAGE Publications. All rights reserved." }