1. In patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) with stable coronary artery disease (CAD), percutaneous coronary intervention (PCI) lowered the risk of death and other major adverse cardiac events (MACEs).
2. PCI was associated with a relatively low risk of procedure-related complications.
Evidence Rating Level: 1 (Excellent)
Study Rundown: AS and CAD are prevalent heart diseases with common risk factors, including metabolic syndrome, atherosclerosis, and increasing age. TAVI is the first-line therapy for severe symptomatic AS, especially in older patients. CAD is present in approximately half the patients presenting for TAVI and is occasionally treated with PCI. However, the risk-benefit consideration of PCI performed for stable CAD in such patients is unclear. This trial compared PCI against conservative management in patients undergoing TAVI for severe AS with stable physiologically significant CAD. PCI resulted in a lower incidence of MACEs including all-cause mortality. The rate of bleeding events was comparable between PCI and conservative management, whereas PCI was associated with a small risk of procedure-related complications. These results were not generalizable to those with recent acute coronary syndrome and left main disease. The timing of PCI relative to TAVI among trial patients was variable, as guidelines are lacking as to the effect of such variability. Notwithstanding, PCI was demonstrated to lower the risk of MACEs including death at 2 years in patients with CAD undergoing TAVI.
Click here to read the study in NEJM
Relevant Reading: ACTIVATION (PercutAneous Coronary inTervention prIor to transcatheter aortic VAlve implantaTION): A Randomized Clinical Trial
In-Depth [randomized controlled trial]: This was a randomized controlled trial comparing PCI against conservative management among patients undergoing TAVI with CAD. Patients undergoing TAVI for severe symptomatic AS, who had at least one stenosis in a coronary artery ≥2.5mm in diameter with a fractional flow reserve (FFR) ≤0.80 or a diameter ≥90%, were eligible for inclusion. Exclusion criteria included planned valve-in-valve TAVI, life expectancy of less than 1 year, severe renal insufficiency, recent acute coronary syndrome, and CAD involving the left main coronary artery. In total, 455 patients were randomized 1:1 to undergo PCI or receive conservative management for their CAD. Patients undergoing PCI typically received lifelong dual antiplatelet therapy consisting of aspirin and clopidogrel, whereas those having had conservative management received life-long aspirin and a limited course of clopidogrel post-TAVI. The primary outcome was a MACE, a composite of death from any cause, myocardial infarction, or urgent revascularization. At a median follow-up of 2 years, a MACE had occurred in 61 patients (26%) in the PCI group and 81 (36%) in the conservative management group (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.51-0.99; p=0.04). Secondary outcomes also favored PCI for myocardial infarction (HR, 0.54; 95% CI 0.30-0.97), urgent revascularization (HR, 0.20; 95% CI, 0.08-0.51), and any revascularization (HR, 0.12; 95% CI, 0.05-0.27). Bleeding events occurred in 28% of patients in the PCI group and 20% in the conservative management group (HR, 1.51; 95% CI, 1.03-2.22). Seven patients (3%) who underwent PCI had a procedure-related complication. These results overall demonstrated superiority of PCI over conservative management, which differed from the previous ACTIVATION trial, which had a smaller sample size and patients with lower angina burden.
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