Outcomes After TAVI in Patients with Atrial Fibrillation and a History of Recent PCI: Results from the ENVISAGE-TAVI AF Trial

Overview

Journal Clin Res Cardiol

Specialty Cardiology & Vascular Diseases

Date 2024 Jan 31

PMID 38294497

Authors

Raul Moreno

Jose Souza

Rudiger Smolnik

Luis Nombela-Franco

Nicolas M Van Mieghem

Christian Hengstenberg

Marco Valgimigli

James Jin

Patrick Ohlmann

George Dangas

Martin Unverdorben

Helge Mollmann

Affiliations

Soon will be listed here.

Abstract

Background: Patients with atrial fibrillation (AF) and a recent (≤ 90 days) percutaneous coronary intervention (PCI) undergoing transcatheter aortic valve implantation (TAVI) are at high bleeding risk due to the addition of oral antiplatelet (OAP) agents on top of oral anticoagulants. Data on outcomes of these patients are needed to optimize antithrombotic treatment.

Methods: This analysis compared annualized clinical event rates in patients with and without a recent PCI enrolled in ENVISAGE-TAVI AF, a prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban and vitamin K antagonists in AF patients after TAVI. The primary efficacy and safety outcomes were net adverse clinical events (NACE) and major bleeding.

Results: Overall, 132 (94.3%) patients with a recent PCI (n = 140) received OAP after TAVI, compared with 692 (55.9%) patients without a recent PCI (n = 1237). Among patients with a recent PCI on OAP agents, use of dual antiplatelet therapy decreased to 5.5%, and use of single antiplatelet therapy (SAPT) increased to 78.0% over 3 months post-randomization. Conversely, use of SAPT predominated at all time points in patients without a recent PCI history. There were no significant differences in the incidence of NACE or other outcomes assessed, except for major bleeding events, which were more frequent in patients with vs without a recent PCI history (hazard ratio [95% confidence interval]: 2.17 [1.27, 3.73]; P = 0.005).

Conclusions: Patients with AF undergoing TAVI with a recent PCI have a similar risk of ischemic events and mortality, but an increased risk of major bleeding compared with patients without a recent PCI.

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