PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation

J. Lønborg*, R. Jabbari, M. Sabbah, K. T. Veien, M. Niemelä, P. Freeman, R. Linder, D. Ioanes, C. J. Terkelsen, O. A. Kajander, S. Koul, M. Savontaus, P. Karjalainen, A. Erglis, M. Minkkinen, R. Sørensen, H. H. Tilsted, L. Holmvang, G. Bieliauskas, J. EllertJ. Piuhola, A. Eftekhari, O. Angerås, A. Rück, E. H. Christiansen, T. Jørgensen, B. T. Özbek, C. Glinge, L. Søndergaard, O. De Backer, T. Engstrøm, for the NOTION-3 Study Group*

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

17 Citations (Scopus)

Abstract

BACKGROUND The 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. METHODS In 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. RESULTS A 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–Predicted 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. CONCLUSIONS Among 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.

Original languageEnglish
JournalNew England Journal of Medicine
Volume391
Issue number23
Pages (from-to)2189-2200
Number of pages12
ISSN0028-4793
DOIs
Publication statusPublished - 2024

Bibliographical note

Publisher Copyright:
Copyright © 2024 Massachusetts Medical Society.

Keywords

  • Cardiology
  • Cardiology General
  • Coronary Disease/Myocardial Infarction
  • Valvular Heart Disease

Cite this