Dabigatran etexilate for secondary stroke prevention: the first year experience from a multicenter short-term registry

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 RELY trial methodology. Results: A total of 78 AF patients (mean age 71 ± 9years; 54% men; 81% IS, 19% TIA; median CHADS 2 (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.

Continuation of Dabigatran Therapy in “Real-World” Practice in Hong Kong

“…Even more alarmingly, the rate of major gastrointestinal bleeding was 4.11%/year in our cohort, substantially higher than that of both the Asian (0.96%/year to 1.15%/year) and non-Asian population (1.14%/year to 1.69%/year) in the RE-LY study [21]. While some studies in the real world setting documented very few bleeding events, ranging from 3.3% to 5.2%,[16], [18], [22] Michel and colleagues revealed that 29% of patients receiving dabigatran had experienced bleeding events, predominantly minor ones [23]. In particular, Ho and colleagues reported the total bleeding and intracranial hemorrhagic risks of 22.95% and 1.64%, respectively, which were even higher than that in our cohort [17].…”

“…Similarly, Miyamoto and colleagues observed that discontinuation of dabigatran was mainly due to dyspepsia, followed by deteriorating renal function, then minor bleeding [16]. On the other hand, a multi-center study reported that high cost accounted for half of the discontinuation whereas gastrointestinal side effects such as dyspepsia and flatulence came next [18]. Of note, dabigatran-induced dyspepsia was much more common in the present cohort than in the RE-LY study (16.5% vs. 11.8% in patients prescribed dabigatran 110 mg two times daily, and 11.3% in those prescribed 150 mg two times daily) [11].…”

Impact of dabigatran on platelet function and fibrinolysis

“…Our previous short-term experience with the use of DE for secondary stroke prevention in NVAF patients has been recently reported [10]. All haemostatic parameters were analyzed before and after treatment with DE.…”

Patient-Reported Treatment Satisfaction with Dabigatran versus Warfarin in Patients with Non-Valvular Atrial Fibrillation in China

“…Various studies have shown different results for the correlation between the costs of dabigatran and long-term persistence. 35,36 To some extent, health insurance played an important part in averting economic hardship and improving medication adherence. 13,37 In China, the high cost of dabigatran, coupled with a lack of medical insurance coverage added to the economic burden, which was a very important factor for dabigatran discontinuation.…”