Are non-vitamin K oral anticoagulants feasible for patients with atrial fibrillation on hemodialysis?

To prevent ischemic thromboembolism and stroke, NOACs (non-vitamin K oral anticoagulants) have become the standard therapy in most atrial fibrillation patients. The safety and efficacy of NOACs in patients on hemodialysis remain unclear.

The researchers performed AXADIA (A Safety Study Assessing Oral Anticoagulation with ApiXAban versus Vitamin K-Antagonists in Patients with Atrial Fibrillation and End-Stage Kidney Disease on Chronic HemoDIAlysis Treatment) -- a prospective, randomized, investigator-initiated, blinded outcome assessment. The trial included patients with AF on chronic hemodialysis. They were randomized to either apixaban 2.5 mg or the vitamin K antagonist phenprocoumon.

The first event of significant bleeding, clinically-relevant non-major bleeding, and all-cause death (composite primary safety outcome) was recorded. A composite of myocardial infarction, ischemic stroke, deep vein thrombosis, all-cause death, and pulmonary embolism (primary efficacy outcome) was also noted.

The authors reported the following findings:

• Thirty-nine sites randomized 97 patients (mean age 75 years, mean CHA2DS2-VASc score 4.5), 48 to apixaban and 49 to VKA. The median follow-up time was 429 vs 506 days, respectively.
• In 44 of 48 patients, adherence to apixaban was >80%; the median time in the therapeutic range on VKA was 50.7%.
• Composite primary safety outcomes occurred in 45.8% of patients on apixaban and 51.0% on VKA (HR 0.93).
• Composite primary efficacy outcome events occurred in 20.8% of patients on apixaban and 30.6% on VKA.
• There were no remarkable differences concerning individual outcomes (all-cause mortality 18.8% vs 24.5%; myocardial infarctions 4.2% vs 6.1%; significant bleeding 10.4% vs 12.2%.

The researchers observed no differences in safety and efficacy outcomes. Even on oral anticoagulation, patients with atrial fibrillation on hemodialysis remained at high risk of CV events.

"Larger randomized trials are required to determine the optimal anticoagulation regimen for AF patients on hemodialysis," the authors wrote in their study.

Reference:

Reinecke H, Engelbertz C, Bauersachs R, Breithardt G, Echterhoff HH, Gerβ J, Haeusler KG, Hewing B, Hoyer J, Juergensmeyer S, Klingenheben T, Knapp G, Rump LC, Schmidt-Guertler H, Wanner C, Kirchhof P, Goerlich D. A Randomized Controlled Trial Comparing Apixaban to the Vitamin K-antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 study. Circulation. 2022 Nov 6. doi: 10.1161/CIRCULATIONAHA.122.062779. Epub ahead of print. PMID: 36335915.