TY - JOUR
T1 - PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation
AU - Lønborg, J.
AU - Jabbari, R.
AU - Sabbah, M.
AU - Veien, K. T.
AU - Niemelä, M.
AU - Freeman, P.
AU - Linder, R.
AU - Ioanes, D.
AU - Terkelsen, C. J.
AU - Kajander, O. A.
AU - Koul, S.
AU - Savontaus, M.
AU - Karjalainen, P.
AU - Erglis, A.
AU - Minkkinen, M.
AU - Sørensen, R.
AU - Tilsted, H. H.
AU - Holmvang, L.
AU - Bieliauskas, G.
AU - Ellert, J.
AU - Piuhola, J.
AU - Eftekhari, A.
AU - Angerås, O.
AU - Rück, A.
AU - Christiansen, E. H.
AU - Jørgensen, T.
AU - Özbek, B. T.
AU - Glinge, C.
AU - Søndergaard, L.
AU - De Backer, O.
AU - Engstrøm, T.
AU - for the NOTION-3 Study Group
N1 - Publisher Copyright:
Copyright © 2024 Massachusetts Medical Society.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - Cardiology
KW - Cardiology General
KW - Coronary Disease/Myocardial Infarction
KW - Valvular Heart Disease
U2 - 10.1056/NEJMoa2401513
DO - 10.1056/NEJMoa2401513
M3 - Journal article
C2 - 39216095
AN - SCOPUS:85206290161
VL - 391
SP - 2189
EP - 2200
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 23
ER -