• Jacob Lønborg, Reza Jabbari, Muhammad Sabbah, Karsten T Veien, Matti Niemelä, Phillip Freeman, Rickard Linder, Dan Ioanes, Christian J Terkelsen, Olli A Kajander, Sasha Koul, Mikko Savontaus, Pasi Karjalainen, Andrejs Erglis, Mikko Minkkinen, Rikke Sørensen, Hans-Henrik Tilsted, Lene Holmvang, Gintautas Bieliauskas, Julia Ellert, Jarkko Piuhola, Ashkan Eftekhari, Oskar Angerås, Andreas Rück, Evald H Christiansen, Troels Jørgensen, Burcu T Özbek, Charlotte Glinge, Lars Søndergaard, Ole De Backer, Thomas Engstrøm, and NOTION-3 Study Group.
• From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis).
• N. Engl. J. Med. 2024 Aug 31.

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.).Copyright © 2024 Massachusetts Medical Society.

13 keywords...

hide…