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. 2025 May 1;36(5):901-910.
doi: 10.1681/ASN.0000000000000495. Epub 2024 Nov 4.

Anticoagulation for Patients with Atrial Fibrillation Receiving Dialysis: A Pilot Randomized Controlled Trial

Ziv Harel  1 , Brendan Smyth  2 , Sunil V Badve  2 , Daniel Blum  3 , William Beaubien-Souligny  4 , Samuel A Silver  5 , Edward Clark  6 , Rita Suri  3 , Thomas A Mavrakanas  3 , Joanna Sasal  7 , Bhanu Prasad  8 , John Eikelboom  9 , Karthik Tennankore  10 , Claudio Rigatto  11 , Ivana Prce  12 , Francois Madore  4 , Fabrice Mac-Way  13 , Andrew Steele  14 , Yangmin Zeng  15 , Michelle Sholzberg  16 , Paul Dorian  17 , Andrew T Yan  17 , Manish M Sood  6 , David J Gladstone  18 , Eric Tseng  19 , Abhijat Kitchlu  20 , Michael Walsh  21 , Danny Sapir  22 , Matthew J Oliver  23 , Murali Krishnan  24 , Mercedeh Kiaii  25 , Nikki Wong  26 , Sradha Kotwal  27 , Marisa Battistella  20 , Rey Acedillo  28 , Charmaine Lok  20 , Matthew Weir  29 , Ron Wald  1
Affiliations

Anticoagulation for Patients with Atrial Fibrillation Receiving Dialysis: A Pilot Randomized Controlled Trial

Ziv Harel et al. J Am Soc Nephrol. .

Abstract

Key Points:

  1. Is performing a large definitive trial to establish the optimal anticoagulation strategy in dialysis recipients with atrial fibrillation feasible?

  2. One hundred fifty-one patients at 28 dialysis centers were enrolled and randomized to apixaban (n=51), warfarin (n=52), or no oral anticoagulation (n=48).

  3. Despite coronavirus disease–related pauses, recruitment was completed in 30 months, with 83% of participants completing follow-up in their assigned treatment arm.

Background: Atrial fibrillation is common in individuals receiving dialysis. The role of oral anticoagulation in this population is uncertain given its exclusion from previous seminal clinical trials. Our objective was to determine the feasibility of performing a large definitive trial to establish the optimal anticoagulation strategy in individuals with atrial fibrillation receiving dialysis.

Methods: The Strategies for the Management of Atrial Fibrillation in Patients Receiving Dialysis trial was a parallel-group, open-label, allocation-concealed, pilot randomized control trial that took place at 28 centers in Canada and Australia. The trial included adults (18 years or older) undergoing dialysis with a history of nonvalvular atrial fibrillation who met the CHADS-65 criteria. Participants were randomized 1:1:1 to receive dose-adjusted warfarin, apixaban 5 mg twice daily, or no oral anticoagulation and followed for 26 weeks. The primary outcomes evaluated the following measures of feasibility: (1) recruitment of the target population within 2 years from the start of the trial and (2) adherence of >80% of randomized patients to the allocated treatment strategy at the conclusion of follow-up. Secondary outcomes included stroke and bleeding.

Results: From December 2019 to June 2022, 151 patients were enrolled and randomized to apixaban (n=51), warfarin (n=52), or no oral anticoagulation (n=48). Allowing for pauses related to the coronavirus disease pandemic, recruitment was completed in 30 months, and 123 (83%) of participants completed follow-up in their allocated treatment arm. There was one adjudicated stroke event. Eight participants had a major bleeding event (four warfarin, two apixaban, two no oral anticoagulation). Death occurred in 15 participants (nine warfarin, two apixaban, four no oral anticoagulation). Time in the therapeutic range for warfarin recipients was 58% (interquartile range, 47%–70%).

Conclusions: We have demonstrated the feasibility of recruitment and adherence in a trial that compared different anticoagulation strategies in patients with atrial fibrillation receiving dialysis.

Clinical Trial registry name and registration number:: Strategies for the Management of Atrial Fibrillation in Patients Receiving Dialysis (SAFE-D), NCT03987711.

Podcast: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/JASN/2025_04_09_ASN0000000000000495.mp3

Keywords: cardiovascular; cardiovascular events; chronic dialysis.

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Conflict of interest statement

Disclosure forms, as provided by each author, are available with the online version of the article at http://links.lww.com/JSN/E945.

References

    1. Koplan BA Winkelmayer WC Costea AI, et al. Implantable loop recorder monitoring and the incidence of previously unrecognized atrial fibrillation in patients on hemodialysis. Kidney Int Rep. 2022;7(2):189–199. doi: 10.1016/j.ekir.2021.10.001 - DOI - PMC - PubMed
    1. Wald R, Dorian P, Harel Z. Benefits and risks of anticoagulation in dialysis patients with nonvalvular atrial fibrillation: navigating through darkness. J Am Coll Cardiol. 2020;75(3):286–288. doi: 10.1016/j.jacc.2019.11.033 - DOI - PubMed
    1. De Vriese AS, Heine G. Anticoagulation management in haemodialysis patients with atrial fibrillation: evidence and opinion. Nephrol Dial Transplant. 2022;37(11):2072–2079. doi: 10.1093/ndt/gfab060 - DOI - PubMed
    1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146(12):857–867. doi: 10.7326/0003-4819-146-12-200706190-00007 - DOI - PubMed
    1. Granger CB Alexander JH McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981–992. doi: 10.1056/NEJMoa1107039 - DOI - PubMed

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