Long-term outcome in patients with non-valvular atrial fibrillation on dabigatran: a prospective cohort study. Issue 11 (2nd November 2018)

• Record Type: Journal Article
• Authors: Verdecchia, Paolo; Vedovati, Maria Cristina; Conti, Serenella; Giustozzi, Michela; Aita, Adolfo; Molini, Gabriella; Angeli, Fabio; Turturiello, Dario; Becattini, Cecilia; Cavallini, Claudio; Agnelli, Giancarlo
• Is Part Of: Expert opinion on drug safety. Volume 17:Issue 11(2018)
• Page Start: 1063
• Page End: 1069
• Publication Date: 2018-11-02
• Subjects: Atrial fibrillation -- stroke -- risk factors -- dabigatran -- bleeding -- mortality -- observational studies; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2018.1529166
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Introduction : Most studies on thromboembolic and bleeding risk in patients with non-valvular atrial fibrillation (NVAF) exposed to non-vitamin K oral anticoagulants stem from interrogation of insurance databases. Areas covered : We studied 742 consecutive patients with NVAF who started treatment with dabigatran in three hospitals in Italy. Average follow-up was 1.80 years. Mean age was 76.2 years. CHA2 DS2 VASc score was 0–1 in 37 (5%), 2 in 97 (13%) and ≥ 3 in 604 (82%) patients. NVAF was permanent in 349 (48%). Overall, 76% of patients remained on treatment over the entire follow-up period. Among 180 patients who discontinued permanently, the most frequent reasons were dyspepsia (33.9%), bleeding (17.8%), and renal worsening (12.1%). About 48% and 74% of permanent discontinuations occurred during the first 6 and 12 months of treatment, respectively. Rates of major events (per 100 patient-years) were 0.75 for stroke, 0.31 for myocardial infarction, 1.50 for all-cause death, and 1.80 for major bleedings. The rate of intracranial bleedings was 0.45 and that of major gastrointestinal bleedings was 0.75. Expert opinion : This prospective cohort study confirms the low incidence of stroke, major bleeding and intracranial bleeding, and a 76% persistence with treatment, in patients with NVAF treated with dabigatran over about 2 years.