The efficacy and safety of direct factor Xa inhibitors versus vitamin K antagonists for atrial fibrillation in patients on hemodialysis: a meta-analysis of randomized controlled trials

Mohamed Abuelazm; Abdelrahman Mahmoud; Shafaqat Ali; Mohamed Gamal; Ahmed Elmezayen; Mohamad A Elzeftawy; Basel Abdelazeem

doi:10.1080/08998280.2023.2247958

The efficacy and safety of direct factor Xa inhibitors versus vitamin K antagonists for atrial fibrillation in patients on hemodialysis: a meta-analysis of randomized controlled trials

Proc (Bayl Univ Med Cent). 2023 Aug 21;36(6):736-743. doi: 10.1080/08998280.2023.2247958. eCollection 2023.

Authors

Mohamed Abuelazm¹, Abdelrahman Mahmoud², Shafaqat Ali³, Mohamed Gamal¹, Ahmed Elmezayen⁴, Mohamad A Elzeftawy¹, Basel Abdelazeem⁵

Affiliations

¹ Faculty of Medicine, Tanta University, Tanta, Egypt.
² Faculty of Medicine, Minia University, Minia, Egypt.
³ Department of Internal Medicine, Louisiana State University, Shreveport, Louisiana, USA.
⁴ Department of Cardiothoracic Surgery, Manchester Foundation Trust, Manchester University, Manchester, UK.
⁵ Department of Cardiology, West Virginia University, Morgantown, West Virginia, USA.

Abstract

Background: Direct factor Xa inhibitors have been extensively prescribed for multiple indications; however, hemodialysis patients have been excluded from most of the randomized controlled trials (RCTs) of direct factor Xa inhibitors. Therefore, the efficacy and safety of direct factor Xa inhibitors versus vitamin K antagonists (VKAs) in hemodialysis patients is uncertain.

Methods: A systematic review and meta-analysis of RCTs was conducted by systematically searching PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane through November 25, 2022. We used the fixed-effect model to pool the risk ratio (RR) with a 95% confidence interval (CI). RevMan v5.4 software was used to pool dichotomous outcomes using RR and continuous outcomes using mean difference presented with the corresponding CI.

Results: Three RCTs with a total of 341 patients were included in our analysis. There was no difference between direct factor Xa inhibitors and VKAs regarding all-cause mortality (RR, 0.99; 95% CI [0.76, 1.30]; P = 0.96), cardiovascular mortality (RR, 1.35; 95% CI [0.71, 2.60]; P = 0.36), noncardiovascular mortality (RR, 0.75; 95% CI [0.53, 1.05]; P = 0.09), sudden mortality (RR, 1.33; 95% CI [0.53, 3.33]; P = 0.54), any cerebrovascular event (RR, 0.52; 95% CI [0.21, 1.29]; P = 0.16), ischemic stroke (RR, 0.51; 95% CI [0.19, 1.37]; P = 0.18), and hemorrhagic stroke (RR, 0.61; 95% CI [0.10, 3.70]; P = 0.59).

Conclusion: In patients with atrial fibrillation who are on hemodialysis, direct factor Xa inhibitors and VKAs were similar in terms of efficacy and safety outcomes. However, evidence is still sparse, warranting dedicated RCTs.

Keywords: Atrial fibrillation; DOACs; hemodialysis; meta-analysis; systematic review.