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Continuous apixaban is a safe and effective option during atrial fibrillation ablation: AXAFA-AFNET 5

EHRA 2018 Congress News

Results from the AXAFA-AFNET 5 trial show that continuous administration of apixaban during atrial fibrillation ablation does not increase the risk of stroke or bleeding compared with vitamin K antagonists (VKAs) and may improve cognitive function compared with pre-ablation values (Abstract LBS10).

Atrial Fibrillation


kirchhof-paulus-2013.jpgProfessor Paulus Kirchhof (University of Birmingham, Birmingham, UK) describes the reasons behind the trial, “Catheter ablation is being used increasingly for atrial fibrillation but the procedure leaves patients at a risk of stroke, small silent brain lesions and bleeding. We also know that thrombolic events can impair cognitive function. In the last five years, research has shown that continuous anticoagulation treatment reduces stroke risk in atrial fibrillation ablation patients. Dabigatran has been shown to be at least as effective as warfarin in this setting,1 but we don’t have data on the use of apixaban.” In the AXAFA-AFNET 5 trial, 633 patients—randomised 1:1—received either continuous apixaban or VKAs.

“In contrast to the dabigatran trial,” explains Prof. Kirchhof, “all the patients in AXAFA-AFNET 5 had risk factors for stroke, resulting in a mean patient age of 64 years, four years older than in other atrial fibrillation ablation trials.”

Another unique feature of the trial was the use of magnetic resonance imaging (MRI) among a sub-group of patients within 48 hours after ablation to quantify acute ischaemic brain lesions.

The trial results demonstrated no significant difference in the primary endpoint—a composite of death, stroke or major bleeding—between treatment arms, with 22 patients experiencing events on apixaban and 23 on VKAs. Prof. Kirchhof notes, “The bleeding rate was half what we expected and there was a remarkably low rate of stroke, with only two events being observed in the trial. In addition, seven episodes of cardiac tamponade—two with apixaban and five with VKAs—were managed with drainage, without the need for antidotes.” The group saw an unexpected improvement in cognitive function in both study groups, as assessed using the Montreal Cognitive Assessment test. There was no difference between the treatments in the number of acute brain lesions among 323 patients undergoing MRI. “Only the second trial to show that continuous non-VKAs are safe during atrial fibrillation ablation, AXAFA-AFNET 5 supports the findings from the dabigatran study and adds to them, confirming that the safety of this approach extends to elderly patients at a risk of stroke,” says Prof. Kirchhof.

“AXAFA-AFNET 5 is the first randomised trial to demonstrate that continuous anticoagulation during atrial fibrillation ablation improves cognitive function.”

“More than that,” he continues, “because the type of VKA and catheter ablation technique used was the choice of the local investigators, a variety of agents and techniques were used. This highlights the applicability of the results to continuous anticoagulation across different clinical practices.” He feels sure that the results will have a big impact on treatment. “When we started the trial two-and-a-half years ago, some centres opted not to take part because they were concerned about the safety of continuous anticoagulation and the lack of experience with apixaban. The results of AXAFA-AFNET 5 will go a long way towards reassuring clinicians that continuous apixaban is a safe and effective alternative to VKAs for patients undergoing atrial fibrillation ablation, even those at risk of stroke.”

References

  1. Calkins H, et al. N Engl J Med 2017;376:1627–36.