Patients receiving dialysis commonly experience atrial fibrillation (AF). However, previous clinical trials examining the role of oral anticoagulation in the treatment of AF have excluded individuals receiving dialysis. Ziv Harel, MD, and colleagues conducted a study to determine the feasibility of performing a large, randomized trial designed to determine the optimal anticoagulation strategy for patients with AF receiving dialysis.
The SAFE-D (Strategies for the Management of Atrial Fibrillation in Patients Receiving Dialysis; NCT03987711) trial, a parallel-group, open-label, allocation-concealed, pilot randomized controlled trial, was conducted at 28 centers in Canada and Australia. The study cohort included adults aged 18 years and older receiving dialysis with a history of nonvalvular AF meeting the CHADS-65 criteria (Canadian Society of Cardiology Guideline).
Eligible participants were randomly assigned 1:1:1 to receive dose-adjusted warfarin, apixaban 5 mg twice daily, or no oral anticoagulation. Follow-up continued for 26 weeks. The primary outcomes of interest were two measures of feasibility: (1) recruitment of the target population within 2 years from the start of the trial and (2) adherence to the assigned treatment strategy at the end of the follow-up period by more than 80% of patients who were randomized. Secondary outcomes were stroke and bleeding.
A total of 151 patients met inclusion criteria and were randomized to receive apixaban (n=51), warfarin (n=52), or no oral anticoagulation (n=48). Allowing for pauses related to the COVID-19 pandemic, recruitment was completed in 30 months (December 2019 to June 2022). Eighty-three percent of participants completed the required follow-up in their treatment arm.
One patient experienced an adjudicated stroke event. Major bleeding events occurred in eight participants: four in the warfarin group, two in the apixaban group, and two in the no oral anticoagulation group. Fifteen patients died: nine in the warfarin group, two in the apixaban group, and four in the no oral anticoagulation group. In the warfarin group, time in the therapeutic range was 58%.
The researchers said, “We have demonstrated the feasibility of recruitment and adherence in a trial that compared different anticoagulation strategies in patients with atrial fibrillation receiving dialysis.”
