Key result
PCI cuts major events ~29% vs conservative management in patients undergoing TAVI.
Why the study?
Does PCI reduce major adverse cardiac events in patients with severe symptomatic aortic stenosis and significant coronary artery disease undergoing TAVI?
RCT (n=455)
1:1
Yes
Does PCI reduce major adverse cardiac events in patients with severe symptomatic aortic stenosis and significant coronary artery disease undergoing TAVI?
In patients undergoing TAVI with concomitant severe coronary artery disease, performing PCI reduces the composite risk of death, myocardial infarction, or urgent revascularization compared to conservative management.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The TAVI PCI trial establishes TAVI first as a legitimate alternative to PCI first, rather than a universal replacement. Contemporary management should emphasize individualized Heart Team decision-making based on coronary anatomy, ischemic significance, bleeding risk, procedural complexity, and anticipated coronary access.”
Supports PCI consideration for CAD before TAVI; extends prior data with randomized confirmation of MACE reduction.
BackgroundThe benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear.MethodsIn an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed.ResultsA total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons–Procedural Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P=0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure–related complications.ConclusionsAmong patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.)
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Lønborg et al. (2024) conducted an RCT in Severe symptomatic aortic stenosis and coronary artery disease (n=455). Percutaneous coronary intervention (PCI) vs. Conservative treatment was evaluated on Composite of death from any cause, myocardial infarction, or urgent revascularization (HR 0.71, 95% CI 0.51 to 0.99, p=0.04). In patients undergoing TAVI, PCI reduced the risk of death, MI, or urgent revascularization compared to conservative treatment (26% vs 36%; HR 0.71, 95% CI 0.51-0.99; P=0.04).
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