A1 Refereed original research article in a scientific journal
PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation
Authors: Lønborg, Jacob; Jabbari, Reza; Sabbah, Muhammad; Veien, Karsten T; Niemelä, Matti; Freeman, Phillip; Linder, Rickard; Ioanes, Dan; Terkelsen, Christian J; Kajander, Olli A; Koul, Sasha; Savontaus, Mikko; Karjalainen, Pasi; Erglis, Andrejs; Minkkinen, Mikko; Sørensen, Rikke; Tilsted, Hans-Henrik; Holmvang, Lene; Bieliauskas, Gintautas; Ellert, Julia; Piuhola, Jarkko; Eftekhari, Ashkan; Angerås, Oskar; Rück, Andreas; Christiansen, Evald H; Jørgensen, Troels; Özbek, Burcu T; Glinge, Charlotte; Søndergaard, Lars; De Backer, Ole; Engstrøm, Thomas; NOTION-3 Study Group
Publisher: Massachusetts Medical Society
Publication year: 2024
Journal: New England Journal of Medicine
Volume: 391
Issue: 23
First page : 2189
Last page: 2200
ISSN: 0028-4793
eISSN: 1533-4406
DOI: https://doi.org/10.1056/NEJMoa2401513
Publication's open availability at the time of reporting: No Open Access
Publication channel's open availability : Partially Open Access publication channel
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.)
Funding information in the publication:
Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.
