ENVISAGE-TAVI AF Trial: What Anticoagulant Should We Use?

Between 15% and 30% of patients undergoing TAVR present atrial fibrillation. Many of them have suffered ischemic stroke before procedure or are at risk of presenting it after procedure. Anticoagulation is indicated in these cases, either with vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC). However, in this context, what the most adequate drug is remains unclear, despite the different analysis available. 

The ENVISAGE-TAVI AF, a randomized prospective multicenter clinical trial, assessed the safety and efficacy of Endoxaban vs VKAs in patients with severe aortic stenosis and atrial fibrillation. This study included 1,337 patients, 41 (3.1%) presented pre-TAVR ischemic stroke; 19 received Endoxaban and the rest, VKAs. In the group with prior ischemic stroke, 1,336 patients were randomized: 673 to Endoxaban and 663 to VKAs.

The groups were well balanced as regards clinical characteristics. Mean age was 82, with mean CHA2DS2-VASc score 4.4, mean HAS-BLED score 1.5, and mortality STS 4.4%. 90% presented hypertension, 34% diabetes, and renal function was conserved. 9% has a history of major bleeding. The presence of systemic embolic events was higher in patients with pre-TAVR ischemic stroke (14.6% vs. 4.8%, p = 0.02). Also, patients with prior ischemic stroke had higher chances of receiving VKAs prior TAVR (65.9% vs. 44.5%, p = 0.01).

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Most ischemic strokes occurred within the first 180 days after TAVR, with no significant differences between treatment groups. After 12 month followup, there were no difference in ischemic stroke rate (2.0 for every 100 patients for Endoxaban and 2.7% for VKAs), or bleeding rate. However, systemic embolic events rate was higher among patients with prior ischemic stroke (14.6% vs. 4.8%, p = 0.02), while MI incidence was lower in this group (2.4% vs. 14.2%, p = 0.04). These patients had received VKA more frequently before TAVR (65.9% vs. 45.4%, p = 0.01).

Ischemic stroke independent risk factors after TAVR were prior presence of systemic embolic events (HR 2.96, CI 95%: 1.26-7.00, p = 0.01) and use of VKAs prior procedure (HR 2.17, CI 95%: 1.12-4.20, p = 0.02).

Conclusion

Even though total incidence of ischemic stroke was low both in patients receiving Endoxaban and those receiving VKAs, after successful TAVR, those with a history of ischemic stroke that had received VKAs could have higher risk of presenting a new ischemic stroke after procedure

Original Title: Risk Factors of Ischemic Stroke in Patients With Atrial Fibrillation After Transcatheter Aortic Valve. Implantation from the Randomized ENVISAGE-TAVI AF Trial.

Reference: Christian Hengstenberg, et al. Am J Cardiol 2024;227:98−104.