Efficacy and Safety of Dabigatran versus Acenocoumarol in “Real World” Patients with Atrial Fibrillation.

Korenstra, J. (2014) Efficacy and Safety of Dabigatran versus Acenocoumarol in “Real World” Patients with Atrial Fibrillation. thesis, Medicine.

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Abstract

Purpose: Randomized trials showed non-inferior or superior results of the direct oral anticoagulants (DOACs) 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. Furthermore, this study was performed to assess the efficiency of elective electrical cardioversion (ECV) planning in patients receiving dabigatran versus acenocoumarol. 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. Efficiency of ECV planning was considered in terms of time till ECV. Results: In total 467 patients with dabigatran and 491 patients with acenocoumarol were enrolled. Mean follow-up duration was 1.3 ±0.6 yr versus 2.3 ±0.9 yr, respectively. On average, the dabigatran patients were a bit younger (69.5 yr vs. 73.3 yr) 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 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). 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). Both median time till first ECV (28 days vs. 36 days, p<0.001), as median time till any ECV (21 days vs. 35 days, p<0.001), were significant shorter in the dabigatran patients as compared with the acenocoumarol patients. 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. Elective ECV planning is more efficient with dabigatran, compared with acenocoumarol.

Item Type:	Thesis (Thesis)
Supervisor name:	Tieleman, Dr. R.G. and Department of Cardiology and Martini Hospital Groningen
Faculty:	Medical Sciences
Date Deposited:	25 Jun 2020 10:43
Last Modified:	25 Jun 2020 10:43
URI:	https://umcg.studenttheses.ub.rug.nl/id/eprint/459

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