Hot Line: Should patients undergo PCI to treat CAD in addition to TAVI?
01 Sep 2024
The NOTION-3 trial was designed to answer the important clinical question about whether patients selected for transcatheter aortic valve implantation (TAVI) who also have coronary artery disease (CAD) should undergo percutaneous coronary intervention (PCI).
NOTION-3 was an open-label, investigator-initiated trial in participants selected for TAVI who had at least one physiologically significant PCI-eligible coronary artery stenosis (fractional flow reserve ≤0.80 or diameter stenosis >90% in a coronary artery ≥2.5 mm in diameter). Patients were randomised to either complete revascularisation with PCI in addition to TAVI or conservative management with TAVI alone. The primary endpoint was the composite of all-cause mortality, myocardial infarction (MI) or urgent revascularisation until the last included patient was followed for 1 year after TAVI.
The trial included 455 patients who had a mean age of around 81 years – around one-third were female. PCI was performed before TAVI in 74% of patients, concomitantly with TAVI in 17% and shortly after in 9%.
The incidence of the primary endpoint was significantly lower in the PCI group than the conservative group (26% vs. 36%, respectively; hazard ratio [HR] 0.71; 95% CI 0.51–0.99; p=0.041) after a median follow-up of 2 years.
Significantly lower rates were observed with PCI vs. conservative treatment for MI (8% vs. 14%; HR 0.54; 95% CI 0.30–0.97; p=0.037) and for urgent revascularisation (2% vs. 11%; HR 0.20; 95% CI 0.08–0.51; p<0.001), with similar rates for all-cause mortality.
The rate of bleeding events – minor, major, life-threatening or disabling – was 28% in the PCI group and 20% in the conservative group (HR 1.51; 95% CI 1.03–2.22).
“NOTION-3 demonstrated that TAVI patients with CAD can derive considerable benefits from PCI, driven by reductions in MI and urgent revascularisation. We suggest that performing PCI should be the recommended treatment for patients undergoing TAVI that have CAD, but the final decision should be made based on the patient’s age, comorbidities, life expectancy and their bleeding risk,” concluded Principal Investigator, Doctor Jacob Thomsen Loenborg (Copenhagen University Hospital - Copenhagen, Denmark).
