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
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 Dec 12;391(23):2189-2200. doi: 10.1056/NEJMoa2401513. Epub 2024 Aug 31.
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.
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.
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.
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.).
经皮冠状动脉介入治疗（PCI）对于接受经导管主动脉瓣植入术（TAVI）的稳定型冠状动脉疾病和严重主动脉瓣狭窄患者的益处仍不明确。
在一项国际试验中，我们将严重症状性主动脉瓣狭窄且至少有一处冠状动脉狭窄、血流储备分数为0.80或更低或直径狭窄至少90%的患者按1:1比例随机分组，分别接受PCI或保守治疗，所有患者均接受TAVI。主要终点是主要不良心脏事件，定义为任何原因导致的死亡、心肌梗死或紧急血运重建的复合事件。评估了安全性，包括出血事件和手术并发症。
共有455例患者进行了随机分组：227例进入PCI组，228例进入保守治疗组。患者的中位年龄为82岁（四分位间距，78至85岁），胸外科医师协会预测的死亡率评分中位数（范围为0至100%，分数越高表明术后30天内死亡风险越高）为3%（四分位间距，2至4）。在中位随访2年（四分位间距，1至4年）时，PCI组有60例患者（26%）发生了主要不良心脏事件（主要终点），保守治疗组有81例（36%）（风险比，0.71；95%置信区间[CI]，0.51至0.99；P = 0.04）。PCI组有64例患者（28%）发生出血事件，保守治疗组有45例（20%）（风险比，1.51；95%CI，1.03至2.22）。在PCI组中，7例患者（3%）发生了与PCI手术相关的并发症。
在接受TAVI的冠状动脉疾病患者中，在中位随访2年时，与保守治疗相比，PCI与任何原因导致的死亡、心肌梗死或紧急血运重建复合事件的风险较低相关。（由波士顿科学公司和丹麦心脏基金会资助；NOTION - 3临床试验注册号，NCT03058627。）
