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Kidney Week

Abstract: TH-PO1140

Strategies for the Management of Atrial Fibrillation in PatiEnts Receiving Dialysis (SAFE-D)

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Author

  • Harel, Ziv, St. Michael's Hospital, Toronto, Ontario, Canada

Group or Team Name

  • SAFE-D Investigators
Background

Atrial fibrillation (AF) is common in patients receiving maintenance dialysis. The role of oral anticoagulation (OAC) in this population is uncertain as dialysis recipients were excluded from landmark randomized control trials (RCTs).

Methods


Objective: To investigate the feasibility of conducting a full-scale RCT to assess the efficacy and safety of OAC in dialysis recipients with AF.

Design, setting, and participants: We conducted a parallel-group, open-label allocation- concealed pilot RCT from December 2019 to December 2022 at 28 centres in Canada and Australia (ClinicalTrials.gov Identifier: NCT03987711). We included adults (≥18 y) undergoing maintenance dialysis with a history of non-valvular AF who met CHADS-65 criteria (i.e. age ≥ 65 y or the presence of at least one stroke risk factor). Exclusion criteria included contraindications to warfarin or apixaban, the need for anticoagulation for conditions other than AF and lack of clinician equipoise.

Interventions: Dialysis recipients were randomized 1:1:1, stratified by centre, to receive dose-adjusted warfarin (targeting an INR of 2-3), apixaban, or no OAC. Follow-up was 26 weeks.

Outcomes: We identified two thresholds for feasibility: recruitment of the target population within 24 months and retention of ≥ 80% of participants in their allocated arm at the end of follow-up. Principal secondary outcomes were ischemic stroke or systemic embolism, and bleeding (defined by International Society of Thrombosis and Hemostasis criteria).

Results

We screened 892 patients and enrolled 151(mean age 71.6 ± 10 y; 25% women; CHADS2-VASc score 4 (IQR 3-5); prior stroke, 13%, prior major bleeding, 9%) who were allocated to apixaban (n =51), warfarin (n=52) or no OAC (n=48). We completed recruitment in 30 months (allowing for pauses related to the pandemic) and 83% of participants completed follow-up in their allocated treatment arm. Stroke occurred in 2 participants (1 apixaban, 1 no OAC), and 27 participants had at least one bleeding event (12 warfarin, 8 apixaban, 7 no OAC) of which 8 were major (4 warfarin, 2 apixaban, 2 no OAC). Death occurred in 15 participants (9 warfarin, 2 apixaban, 4 no OAC). Time in the therapeutic range for warfarin users was 58% (IQR 47%-70%).

Conclusion

This pilot RCT supports the feasibility of conducting a definitive RCT to inform the effect of OAC on clinical outcomes in dialysis recipients with AF.

Funding

  • Government Support - Non-U.S.