PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation
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| Názov: | PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation |
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| Autori: | 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 |
| Zdroj: | Lønborg, J, Jabbari, R, Sabbah, M, Veien, K T, Niemelä, M, Freeman, P, Linder, R, Ioanes, D, Terkelsen, C J, Kajander, O A, Koul, S, Savontaus, M, Karjalainen, P, Erglis, A, Minkkinen, M, Sørensen, R, Tilsted, H-H, Holmvang, L, Bieliauskas, G, Ellert, J, Piuhola, J, Eftekhari, A, Angerås, O, Rück, A, Christiansen, E H, Jørgensen, T, Özbek, B T, Glinge, C, Søndergaard, L, De Backer, O, Engstrøm, T & the NOTION-3 Study Group 2024, 'PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation.', The New England Journal of Medicine, vol. 391, no. 23, pp. 2189-2200. https://doi.org/10.1056/NEJMoa2401513 Lønborg, J, Jabbari, R, Sabbah, M, Veien, K T, Niemelä, M, Freeman, P, Linder, R, Ioanes, D, Terkelsen, C J, Kajander, O A, Koul, S, Savontaus, M, Karjalainen, P, Erglis, A, Minkkinen, M, Sørensen, R, Tilsted, H-H, Holmvang, L, Bieliauskas, G, Ellert, J, Piuhola, J, Eftekhari, A, Angerås, O, Rück, A, Christiansen, E H, Jørgensen, T, Özbek, B T, Glinge, C, Søndergaard, L, De Backer, O, Engstrøm, T & NOTION-3 Study Group 2024, 'PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation', The New England Journal of Medicine, vol. 391, no. 23, pp. 2189-2200. https://doi.org/10.1056/NEJMoa2401513 |
| Informácie o vydavateľovi: | Massachusetts Medical Society, 2024. |
| Rok vydania: | 2024 |
| Predmety: | Male, Cardiology, Myocardial Infarction, Hemorrhage, Coronary Artery Disease, Kaplan-Meier Estimate, Postoperative Hemorrhage, Conservative Treatment, Hemorrhage/epidemiology, Transcatheter Aortic Valve Replacement, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Coronary Disease/Myocardial Infarction, Conservative Treatment/adverse effects, Myocardial Infarction/epidemiology, Coronary Artery Disease/therapy, Humans, Aortic Valve Stenosis/surgery, Percutaneous Coronary Intervention/adverse effects, Aged, Aged, 80 and over, Postoperative Hemorrhage/epidemiology, Aortic Valve Stenosis, 3. Good health, Cardiology General, Transcatheter Aortic Valve Replacement/adverse effects, Valvular Heart Disease, Female, Follow-Up Studies |
| Popis: | 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.). |
| Druh dokumentu: | Article |
| Jazyk: | English |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa2401513 |
| Prístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/39216095 https://vbn.aau.dk/da/publications/6d5626f1-d714-40e5-b7ba-f30d3922a2b8 http://www.scopus.com/inward/record.url?scp=85206290161&partnerID=8YFLogxK https://doi.org/10.1056/NEJMoa2401513 https://portal.findresearcher.sdu.dk/da/publications/585dac03-ecaa-4074-a036-9f57eedc99c3 https://doi.org/10.1056/NEJMoa2401513 https://pure.au.dk/portal/en/publications/9a7a7c09-02fb-4002-9b5f-3cf4f3b92c42 http://www.scopus.com/inward/record.url?scp=85206290161&partnerID=8YFLogxK https://doi.org/10.1056/NEJMoa2401513 |
| Rights: | URL: http://www.nejmgroup.org/legal/terms-of-use.htm |
| Prístupové číslo: | edsair.doi.dedup.....f8488416c2d776b6409d800bc46a73dd |
| Databáza: | OpenAIRE |
| Abstrakt: | 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.). |
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| ISSN: | 15334406 00284793 |
| DOI: | 10.1056/nejmoa2401513 |
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