Dabigatran etexilate for secondary stroke prevention

The first year experience from a multicenter short-term registry

Georgios Tsivgoulis, Christos Krogias, Kara A. Sands, Vijay K. Sharma, Aristeidis H. Katsanos, Konstantinos Vadikolias, Ioannis Heliopoulos, Athina Mitsoglou, Sotirios Giannopoulos, Charitomeni Piperidou, Konstantinos Voumvourakis, Andrei Alexandrov, Sokratis G. Papageorgiou, Chrissoula Liantinioti, Dimitrios Athanasiadis

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)155-161
Number of pages7
JournalTherapeutic Advances in Neurological Disorders
Volume7
Issue number3
DOIs
StatePublished - Jan 1 2014

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Secondary Prevention
Registries
Stroke
Hemorrhage
Transient Ischemic Attack
Atrial Fibrillation
Safety
Dabigatran
Costs and Cost Analysis
Intracranial Hemorrhages
Dyspepsia
Hematuria
Embolism
Tertiary Care Centers
Population
Length of Stay
Diabetes Mellitus
Heart Failure
Myocardial Infarction
Hypertension

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Neurology
  • Clinical Neurology

Cite this

Dabigatran etexilate for secondary stroke prevention : The first year experience from a multicenter short-term registry. / Tsivgoulis, Georgios; Krogias, Christos; Sands, Kara A.; Sharma, Vijay K.; Katsanos, Aristeidis H.; Vadikolias, Konstantinos; Heliopoulos, Ioannis; Mitsoglou, Athina; Giannopoulos, Sotirios; Piperidou, Charitomeni; Voumvourakis, Konstantinos; Alexandrov, Andrei; Papageorgiou, Sokratis G.; Liantinioti, Chrissoula; Athanasiadis, Dimitrios.

In: Therapeutic Advances in Neurological Disorders, Vol. 7, No. 3, 01.01.2014, p. 155-161.

Research output: Contribution to journalArticle

Tsivgoulis, G, Krogias, C, Sands, KA, Sharma, VK, Katsanos, AH, Vadikolias, K, Heliopoulos, I, Mitsoglou, A, Giannopoulos, S, Piperidou, C, Voumvourakis, K, Alexandrov, A, Papageorgiou, SG, Liantinioti, C & Athanasiadis, D 2014, 'Dabigatran etexilate for secondary stroke prevention: The first year experience from a multicenter short-term registry', Therapeutic Advances in Neurological Disorders, vol. 7, no. 3, pp. 155-161. https://doi.org/10.1177/1756285614528064
Tsivgoulis, Georgios ; Krogias, Christos ; Sands, Kara A. ; Sharma, Vijay K. ; Katsanos, Aristeidis H. ; Vadikolias, Konstantinos ; Heliopoulos, Ioannis ; Mitsoglou, Athina ; Giannopoulos, Sotirios ; Piperidou, Charitomeni ; Voumvourakis, Konstantinos ; Alexandrov, Andrei ; Papageorgiou, Sokratis G. ; Liantinioti, Chrissoula ; Athanasiadis, Dimitrios. / Dabigatran etexilate for secondary stroke prevention : The first year experience from a multicenter short-term registry. In: Therapeutic Advances in Neurological Disorders. 2014 ; Vol. 7, No. 3. pp. 155-161.
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AU - Heliopoulos, Ioannis

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