NOTION-3: TAVI plus PCI improves outcomes in CAD plus severe aortic stenosis

In patients with stable coronary artery disease (CAD) and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), the addition of percutaneous coronary intervention (PCI) to the treatment strategy was associated with a reduction in major adverse cardiovascular events (MACE) compared with TAVI plus conservative treatment. Since these 2 conditions often co-exist, these NOTION-3 findings may help to improve the clinical outcomes for a large group of patients.

“TAVI and PCI are performed simultaneously in about 15% of patients undergoing TAVI for severe aortic stenosis,” according to Dr Jacob Lønborg (Copenhagen University Hospital, Denmark) [1]. “There is, however, no evidence from clinical trials to support this strategy.” Thus, the aim of the NOTION-3 study (NCT03058627) was to test the hypothesis that routine revascularisation with PCI in addition to TAVI will improve clinical outcomes in patients with stable CAD and severe aortic stenosis compared with TAVI plus conservative management. The 455 participants were randomised 1:1 to TAVI plus conservative management or TAVI plus PCI. The primary endpoint was MACE at 1–5 years of follow-up.

After a median of 2 years of follow-up, TAVI plus PCI reduced MACE relative to TAVI alone, with event rates of 26% and 36%, respectively (HR 0.71; 95% CI 0.51–0.99; P=0.04). Looking at individual components of MACE, the authors observed no statistically significant difference between the 2 study arms regarding all-cause mortality (23% vs 27%; HR 0.85; 95% CI 0.59–1.23) but did report improved outcomes in the PCI arm for myocardial infarction (7% vs 14%; HR 0.54; 95% CI 0.30–0.97), and urgent revascularisation (2% vs 11%; HR 0.20; 95% CI 0.08–0.51). “We did notice an increased risk for bleeding in the PCI arm,” said Dr Lønborg (28% vs 20%; HR 1.51; 95% CI 1.03–2.22). “On the other hand, acute kidney failure was more common in the conservative treatment arm” (5% vs 11%; HR 0.45; 95% CI 0.23–0.89).

“Based on the results of our study, adding PCI to TAVI appears to be a solid strategy to treat patients with severe aortic stenosis and stable CAD,” concluded Dr Lønborg.

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   1. Lønborg J, et al. NOTION-3: PCI in patients undergoing transcatheter aortic valve implantation. HOTLINE 5, ESC Congress 2024, 30 Aug–02 Sept, London, UK.

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Posted on 7 November 20247 November 2024