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In the AXADIA – AFNET 8 trial, oral anticoagulation with the non-vitamin K antagonist oral anticoagulant (NOAC) Apixaban appeared equally safe and effective as vitamin K antagonists (VKA) in patients with atrial fibrillation (AF) and severe chronic kidney disease. The results were presented at the American Heart Association (AHA) congress on 06.11.2022 in Chicago, USA [1] and simultaneously published in Circulation [2].
AXADIA – AFNET 8 (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) is an investigator-initiated trial with the objective of improving oral anticoagulation in patients with atrial fibrillation and chronic kidney disease on hemodialysis. It compared the NOAC Apixaban to VKA in these multimorbid patients.
Professor Holger Reinecke, University Hospital Münster, Germany, principal investigator of AXADIA – AFNET 8, explained the background of the trial: “Patients with atrial fibrillation and chronic kidney disease are at high risk for stroke and therefore in dire need of antithrombotic therapy. However, anticoagulation is challenging in this vulnerable patient group. These patients are prone to bleeding and show a high rate of life-threatening complications under oral anticoagulation as we know from the experience with VKA.”
In the past few years, NOACs have become the standard therapy for preventing stroke and ischemic thromboembolism in patients with AF, but the efficacy and safety of NOACs in patients on hemodialysis is not well known. The NOAC Apixaban was chosen for this trial because it is mainly eliminated via metabolization and excretion in the liver, rendering Apixaban a suitable NOAC in patients with chronic kidney disease.
From June 2017 until May 2022, 39 study sites in Germany randomized 97 patients with AF on chronic hemodialysis to either Apixaban (2.5 mg bid) (48 patients) or the VKA phenprocoumon (INR 2.0-3.0) (49 patients). The median follow-up time was 429 (range 37-1,370) versus 506 (range 101-1,379) days, respectively.
The composite primary safety endpoint – defined by a first event of major bleeding, clinically-relevant non-major bleeding, or all-cause death – occurred in 22 (45.8%) patients on Apixaban and in 25 (51.0%) patients on VKA (HR 0.931, 95% CI 0.525-1.651, p(noninferiority)=0.1567).
The primary efficacy endpoint – a composite of ischemic stroke, all-cause death, myocardial infarction, and deep vein thrombosis and/or pulmonary embolism – occurred in 10 (20.8%) patients on Apixaban and in 15 (30.6%) patients on VKA (p=0.51, log rank).
There were no significant differences regarding individual outcomes (mortality 18.8% vs. 24.5%; major bleedings 10.4 vs. 12.2%; myocardial infarctions 4.2. vs. 6.1%, respectively).
Professor Reinecke concluded: “AXADIA – AFNET 8 was not able to recruit the planned number of participants in this multimorbid patient population. Thus, we missed the predefined non-inferiority margin for apixaban to VKA. Nevertheless, in this largest prospective trial in patients with AF on hemodialysis with long follow-up, Apixaban appears equally safe and effective as VKA. The results also show: even on oral anticoagulation, patients with AF on hemodialysis remain at high risk of cardiovascular events. Taken together with other observational publications, our findings support the use of Apixaban in patients with AF on hemodialysis.”
AXADIA – AFNET 8 was initiated and conducted by AFNET. Financial Support was provided by Bristol-Myers Squibb and Pfizer.
References
Reinecke H, Bauersachs R, Breithardt G, Engelbertz C, Gerss J, Goerlich D, Juergensmeyer S, Wanner C, Kirchhof P. 2022. Apixaban or Vitamin K Antagonistsfor Stroke Preventionin Patients with Atrial Fibrillation on Hemodialysis: Results of the Randomized AXADIA – AFNET 8 trial. AHA congress abstract 2022
Reinecke H, Engelbertz C, Bauersachs R, Breithardt G, Echterhoff H, Gerss J, Haeusler KG, Hewing B, Hoyer J, Juergensmeyer S, Klingenheben T, Knapp G, Rump LC, Schmidt-Guertler H, Wanner C, Kirchhof P, Goerlich D. 2022. A randomized controlled trial comparing apixaban to the vitamin K-antagonist phenprocoumon in patients on chronic hemodialysis – the AXADIA – AFNET 8 study. Circulation 06.11.2022. doi: 10.1161/CIRCULATIONAHA.122.062779
Reinecke H, Jürgensmeyer S, Engelbertz C, Gerss J, Kirchhof P, Breithardt G, Bauersachs R, Wanner C. Design and rationale of a randomised controlled trial comparing apixaban to phenprocoumon in patients with atrial fibrillation on chronic haemodialysis: the AXADIA – AFNET 8 study. BMJ Open 2018 Sep 10. doi: 10.1136/bmjopen-2018-022690
Press Contact
Angelika Leute, PhD
Phone: +49 202 2623395
a.leute@t-online.de
About the Atrial Fibrillation NETwork (AFNET)
The Atrial Fibrillation NETwork is an interdisciplinary research network comprising scientists and physicians from hospitals and practices dedicated to improving the management of atrial fibrillation through coordinated research in Germany, Europe, and worldwide. Its main objective is to conduct high quality investigator-initiated clinical trials and registries on a national and international level. The AFNET continues the long-term activities of the network which has been funded by the German Federal Ministry of Research and Education over a decade. Since January 2015, specific projects and infrastructures of the AFNET are funded by the German Centre for Cardiovascular Research (DZHK).
Reinecke H et al. A randomized controlled trial comparing apixaban to the vitamin K-antagonist phenprocoumon in patients on chronic hemodialysis – the AXADIA – AFNET 8 study. Circulation 06.11.2022. doi: 10.1161/CIRCULATIONAHA.122.062779
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