Key result
Recent PCI before TAVI in AF is linked to ~117% higher major bleeding with similar NACE.
Why the study?
Patients with AF and recent PCI undergoing TAVI have high bleeding risk from combined oral antiplatelet and anticoagulant therapy, and outcome data are needed to optimize antithrombotic treatment.
Does a recent history of PCI increase the risk of adverse clinical events or major bleeding in patients with atrial fibrillation undergoing TAVI?
Cohort (n=1,377)
Open-label, adjudicator-masked
Yes
Does a recent history of PCI increase the risk of adverse clinical events or major bleeding in patients with atrial fibrillation undergoing TAVI?
Hazard Ratio: 1.55 (95% CI 0.98–2.45)
Absolute Event Rate: 22.94% vs 14.28%
p-value: p=0.06
In patients with atrial fibrillation undergoing TAVI, a recent history of PCI is associated with an increased risk of major bleeding but similar ischemic outcomes compared to those without a recent PCI.
Recent PCI was associated with higher bleeding risk without excess NACE in AF-TAVI patients; leaves open optimal antithrombotic strategies.
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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Moreno et al. (2024) conducted a cohort in Atrial fibrillation in patients undergoing transcatheter aortic valve implantation (n=1,377). Recent percutaneous coronary intervention (≤90 days) vs. No recent percutaneous coronary intervention was evaluated on Net adverse clinical events (NACE) (HR 1.55, 95% CI 0.98, 2.45, p=0.06). Patients with atrial fibrillation undergoing TAVI with a recent PCI had a similar risk of net adverse clinical events (HR 1.55) but a significantly increased risk of major bleeding (HR 2.17) compared to those without a recent PCI.
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