Dr. Ahmet Karaduman

NOTION-3 - Percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation

Link :
https://www.nejm.org/doi/abs/10.1056/NEJMoa2401513

Abstract

Background:
Aortic stenosis (AS) and coronary artery disease (CAD) often coexist, sharing common risk factors and clinical presentations. Severe aortic stenosis is the most common valvular heart disease, with an increasing prevalence due to aging populations. Transcatheter aortic valve implantation (TAVI) is the standard treatment for severe symptomatic AS, especially in elderly patients, regardless of their surgical risk. Approximately 50% of patients undergoing TAVI also have CAD, and in some cases, percutaneous coronary intervention (PCI) is performed to manage significant coronary lesions. However, the benefits of PCI in addition to TAVI remain controversial, particularly when CAD is identified incidentally.

Methods:
This international, open-label, randomized controlled trial included patients with severe symptomatic aortic stenosis undergoing TAVI and physiologically significant coronary artery stenosis (with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90%). Patients were randomly assigned in a 1:1 ratio to undergo PCI prior to TAVI or to receive conservative treatment without PCI. The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety endpoints, including bleeding and procedural complications, were also assessed.

Results:
A total of 455 patients were randomized, with 227 assigned to the PCI group and 228 to the conservative treatment group. The median age was 82 years (interquartile range, 78-85). At a median follow-up of 2 years, MACE occurred in 26% of the PCI group compared to 36% in the conservative group (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). The incidence of bleeding events was higher in the PCI group (28%) compared to the conservative group (20%) (HR, 1.51; 95% CI, 1.03 to 2.22).

Conclusions:
In patients with severe aortic stenosis undergoing TAVI, PCI was associated with a reduced risk of major adverse cardiac events compared to conservative treatment. However, the risk of bleeding was significantly higher with PCI. These findings suggest that while PCI may be beneficial in reducing MACE in this population, the decision to perform PCI should be individualized, considering the patient's overall risk profile, including bleeding risk.

Interpretations:
This study demonstrates that performing PCI in conjunction with TAVI in patients with severe aortic stenosis and coexisting coronary artery disease reduces the risk of major adverse cardiac events, such as death, myocardial infarction, or urgent revascularization. However, it also significantly increases the risk of bleeding. These findings highlight the need for careful consideration of the potential benefits and risks of PCI with TAVI, with treatment decisions being individualized based on the patient's overall clinical profile