Abstract 16338: Efficacy and Safety of Dabigatran versus Acenocoumarol in “Real World” Patients With Atrial Fibrillation
Purpose: Randomized trials showed non-inferior or superior results of the non-vitamin K oral anticoagulants (NOACs) compared with warfarin. The aim of this study was to assess the efficacy and safety of dabigatran versus acenocoumarol in patients with atrial fibrillation (AF) in daily clinical practice.
Methods: In this retrospective study we evaluated all patients who started anticoagulation because of AF in our outpatient clinic from 2010 till 2012. In later years we preferably prescribed dabigatran. Data were collected from the electronical patient chart. Primary outcomes were stroke or systemic embolism and major bleeding, based on the definitions used in the RE-LY study.
Results: In total 467 patients with dabigatran and 491 patients with acenocoumarol were enrolled. Mean follow-up duration was 1.3±0.6yr versus 2.3±0.9yr, respectively. On average, the dabigatran patients were a bit younger (69.5yr vs. 73.3yr) and more often male (55.5% vs. 48.3%) as compared with the acenocoumarol patients. The mean calculated stroke risk according to the CHA2DS2-VASc score for the dabigatran group was 3.2%/yr versus 4.0%/yr in the acenocoumarol group. According to the HAS-BLED score the dabigatran patients had a mean calculated bleeding risk of 1.7%/yr, where the acenocoumarol patients had a bleedings risk of 1.8%/yr. Multivariate Cox regression analysis (MVA) revealed that major bleeding occurred significantly less frequent in the dabigatran patiënts compared with the acenocoumarol patients (2.0%/yr vs. 3.7%/yr, respectively, HR=0.47, p=0.032, figure 1). There was no significant difference in the occurrence of stroke or systemic embolism between the dabigatran group and the acenocoumarol group (both 1.0%/yr, HR=0.84, p=0.734).
Conclusion: In “real world” patients with AF, dabigatran appears to be superior in safety and non-inferior in efficacy compared with acenocoumarol. The HAS-BLED score seems to underestimate the bleeding risk in acenocoumarol patients.
Author Disclosures: J. Korenstra: None. P. Wijtvliet: None. C. Geluk: None. L. Bartels: None. J. Posma: None. I. van Gelder: None. R. Tieleman: None.
- © 2014 by American Heart Association, Inc.