Are Direct Oral Anticoagulants Safe in Patients With End-stage Renal Disease?

Are Direct Oral Anticoagulants Safe in Patients With End-stage Renal Disease?

Information sourced from NEJM Journal Watch:

Are Direct Oral Anticoagulants Safe in Patients with End-Stage Renal Disease?

The answer might be yes, according to a retrospective analysis of dialysis patients with atrial fibrillation prescribed apixaban.

Patients with atrial fibrillation (AF) and end-stage renal disease (ESRD) who are on dialysis have elevated risks for thromboembolic events and bleeding. The FDA, relying solely on pharmacokinetic data, approved standard-dose apixaban in dialysis patients in 2012. For real-world insights, investigators analyzed 2010–2015 data from the U.S. Renal Data System on 25,523 patients with ESRD on dialysis who began oral anticoagulation (apixaban or warfarin). Patients were matched on a prognostic score for each outcome (apixaban, 2351 patients; warfarin, 7053 patients).

Following the FDA’s apixaban approval, new prescriptions for ESRD patients with AF increased annually. Overall, the risk of stroke/systemic emboli was 11.9 per 100 person-years. Risks for thromboembolism did not differ between apixaban or warfarin, but apixaban was associated with a lower risk for major bleeding (hazard ratio, 0.72). In a sensitivity analysis, the standard apixaban dose of 5 mg twice daily was associated with lower risks for stroke and systemic embolism than half-dose apixaban (taken by 56% of patients).

COMMENT

This well-designed, retrospective, observational study yields multiple insights. First, traditional risk scores underestimate the high risk of thromboembolism in ESRD patients with AF. Second, despite a lack of clinical safety and efficacy data, direct oral anticoagulants are increasingly used in ESRD patients with AF. Third, apixaban in these patients is associated with reductions in thromboembolism and major bleeding. However, only the standard apixaban dose conferred these benefits, but most patients were prescribed the reduced dose, possibly suggesting inappropriate underdosing of some patients. These results are compelling but insufficient for the routine recommendation of direct oral anticoagulants for thromboembolic prevention in ESRD patients. I await the results from the ongoing RENAL-AF study, which might be practice changing.

Fatima Rodriguez, MD, MPH reviewing Siontis KC et al. Circulation 2018 Jun 28

Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.

CITATION(S):

Siontis KC et al. Outcomes associated with apixaban use in end-stage kidney disease patients with atrial fibrillation in the United States. Circulation 2018 Jun 28; [e-pub].
[PubMed® abstract]

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