Comparison of Dabigatran Versus Warfarin Treatment for Prevention of New Cerebral Lesions in Valvular Atrial Fibrillation
Introduction
Ischemic stroke is a major complication of atrial fibrillation (AF).1 AF patients with underlying valvular heart disease (VHD) are at higher risk of ischemic stroke in population-based studies.2,3 Standard anticoagulation is, therefore, the cornerstone of managing patients with AF and VHD. The nonvitamin K antagonist oral anticoagulants (NOAC) have replaced a large portion of warfarin use given their better efficacy and safety profiles, proved in multiple randomized controlled trials.4, 5, 6, 7 However, the role of NOACs in managing valvular AF remains undetermined, particularly in AF associated with mitral stenosis (MS).8 Dabigatran etexilate is a NOAC used to treat nonvalvular AF; evidence on the efficacy and safety of dabigatran in AF patients with native VHD is lacking. In addition, excessive risk and no benefit has been observed in patients with a mechanical prosthetic valve.9 An observational study of patients with MS and AF has suggested a positive role of NOAC in these patients; however, there were no prospective data available.10 The DECISIVE (Effectiveness of Dabigatran vs Conventional Treatment for Prevention of Silent Cerebral Infarct in Aortic and Mitral Valvular Atrial Fibrillation Patients) trial was designed to assess the therapeutic impact of dabigatran in patients with AF and left-sided VHD. We hypothesized that dabigatran would be superior to conventional treatment (warfarin or aspirin) for preventing subclinical ischemic stroke and intracranial bleeding.
Section snippets
Methods
This study was a prospective, single-center, open-label, randomized controlled trial to evaluate the efficacy and safety of dabigatran compared with warfarin in patients with valvular AF. Boehringer Ingelheim (Ingelheim, Germany) partially funded the study and provided the drug; however, they had no role in data collection, analysis, interpretation, or presenting the results. The study protocol was approved by the institutional review board of our institution (2016-0869), and written informed
Results
The number of patients who were screened, randomized, and assigned to each study group is shown in Figure 1. We enrolled 120 patients between March 2017 and October 2019 and randomly assigned them at a 1:1 ratio to the dabigatran or conventional treatment groups. One patient in the dabigatran group withdrew consent immediately after randomization, resulting in 59 patients in the dabigatran group and the baseline evaluation of 119 patients. A crossover occurred in 5 patients in the dabigatran
Discussion
In this open-label, randomized trial, we found no significant difference in the primary end points between dabigatran and conventional treatment in patients with AF and significant left-sided VHD.
The pivotal randomized trial of 4 NOACs excluded patients with moderate or severe MS and prosthetic heart valves.4, 5, 6, 7 In the sub-analysis of the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial, which included patients with VHD (except moderate–severe MS or mechanical
Disclosures
The authors have no conflicts of interest to declare.
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Cited by (2)
Comparison of Dabigatran Versus Warfarin Treatment for the Prevention of New Cerebral Lesions in Valvular Atrial Fibrillation
2022, American Journal of Cardiology
Boehringer Ingelheim partially funded the study and provided the drug; however, they had no role in data collection, analysis, interpretation, or presenting the results.