What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Atrial fibrillation or Venous Thromboembolism and End-Stage renal disease on hemodialysis (n=9862). Intervention: Apixaban vs. Warfarin. Primary outcome: Systemic embolic events (composite of stroke and systemic embolism) (RR 0.65, 95% CI 0.52-0.83, p=0.0004).

April 16, 2021Open Access

Safety and Efficacy of Apixaban versus warfarin in patients with atrial fibrillation or Venous Thromboembolism and End-Stage renal disease on hemodialysis: A systematic review and meta-analysis

Key Result

Apixaban significantly reduced the risk of systemic embolic events (RR 0.65) and major bleeding (RR 0.53) compared to warfarin in patients with end-stage renal disease on hemodialysis.

Study Design

Type

Meta-Analysis (n=9,862)

Structured PICO

Does apixaban reduce systemic embolic events and bleeding compared to warfarin in patients with end-stage renal disease on hemodialysis?

Population

9,862 adult patients with end-stage renal disease on hemodialysis and atrial fibrillation or venous thromboembolism, followed for a mean of 327 days.

Intervention

Apixaban (2.5 mg BID or 5 mg BID)

Comparator

Warfarin

Outcome

Prevention of systemic embolic events (composite of stroke and systemic embolism)composite

Apixaban demonstrates a favorable efficacy and safety profile compared to warfarin in ESRD patients on hemodialysis, significantly reducing systemic embolic events and major bleeding.

Main Result

Relative Risk: 0.65 (95% CI 0.52–0.83)

Absolute Event Rate: 3.31% vs 5.22%

p-value: p=0.0004

Limitations

Patient selection bias due to the small sample size and retrospective nature of the included studies
Studies included in the pooled analysis come only from the United States, limiting generalizability
Subgroup analysis comparing low dose versus standard dose apixaban could not be performed
Included studies evaluated Apixaban and Warfarin for various indications
Patient-level data for INR management or time in therapeutic range was not available
Results were primarily driven by one large study (Siontis et al.)
Publication bias could not be evaluated due to having fewer than ten studies

Abstract

BACKGROUND: Warfarin is traditionally the drug of choice for stroke prophylaxis or treatment of venous thromboembolism in patients with end-stage renal disease (ESRD) on hemodialysis as data on apixaban use is scarce. We aimed to assess the safety and efficacy of Apixaban in patients with ESRD on hemodialysis when compared with warfarin. METHODS: A comprehensive literature search in PubMed, Google Scholar, and Cochrane databases from inception until Nov 25, 2019, was performed. Studies reporting clinical outcomes comparing Apixaban (2.5 mg BID or 5 mg BID) versus Warfarin in ESRD patients on hemodialysis were included. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data. RESULTS: Four studies (three retrospective and one randomized) with a total of 9862 patients (apixaban = 2,547, warfarin = 7315) met inclusion criteria. The overall mean age was 66.6 ± 3.9 years and mean CHA2DS2-VASc score 4.56 ± 0.58. Apixaban was associated with lower rates of major bleeding (RR 0.53, 95% CI 0.45-0.64, p < 0.0001], gastrointestinal (GI) bleed (RR 0.65, 95% CI 0.55-0.76, p < 0.0001), intracranial bleed (RR 0.56, 95% CI 0.36-0.89, p = 0.01), and stroke/systemic embolism RR 0.65, 95% CI 0.52-0.83, p = 0.0004 compared with warfarin in patients with ESRD on hemodialysis. There was no significant increased risk of all-cause mortality with the apixaban vs. warfarin (RR 0.90, 95% CI 0.41-1.96, p = 0.78). CONCLUSION: Apixaban had an overall favorable risk-benefit profile, with significant reductions in ischemic stroke, major bleeding, and intracranial bleeding compared to Warfarin in ESRD patients on hemodialysis with non-valvular AF and/or venous thromboembolism.

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