Thomas Modine, Didier Tchétché, Nicolas M Van Mieghem, G Michael Deeb, Stanley J Chetcuti, Steven J Yakubov, Paul Sorajja, Hemal Gada, Mubashir Mumtaz, Basel Ramlawi, Tanvir Bajwa, John Crouch, Paul S Teirstein, Neal S Kleiman, Ayman Iskander, Rodrigo Bagur, Michael W A Chu, Pierre Berthoumieu, Arnaud Sudre, Rik Adrichem, Saki Ito, Jian Huang, Jeffrey J Popma, John K Forrest, Michael J Reardon
{"title":"年轻(小于 75 岁)低手术风险重度主动脉瓣狭窄患者 TAVR 术后三年的疗效。","authors":"Thomas Modine, Didier Tchétché, Nicolas M Van Mieghem, G Michael Deeb, Stanley J Chetcuti, Steven J Yakubov, Paul Sorajja, Hemal Gada, Mubashir Mumtaz, Basel Ramlawi, Tanvir Bajwa, John Crouch, Paul S Teirstein, Neal S Kleiman, Ayman Iskander, Rodrigo Bagur, Michael W A Chu, Pierre Berthoumieu, Arnaud Sudre, Rik Adrichem, Saki Ito, Jian Huang, Jeffrey J Popma, John K Forrest, Michael J Reardon","doi":"10.1161/CIRCINTERVENTIONS.124.014018","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.</p><p><strong>Methods: </strong>The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.</p><p><strong>Results: </strong>In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (<i>P</i>=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; <i>P</i>=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; <i>P</i><0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, <i>P</i>=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (<i>P</i><0.001) and lower rates of severe prosthesis-patient mismatch (<i>P</i><0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.</p><p><strong>Conclusions: </strong>Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.</p><p><strong>Registration: </strong>URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014018"},"PeriodicalIF":6.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11573113/pdf/","citationCount":"0","resultStr":"{\"title\":\"Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients.\",\"authors\":\"Thomas Modine, Didier Tchétché, Nicolas M Van Mieghem, G Michael Deeb, Stanley J Chetcuti, Steven J Yakubov, Paul Sorajja, Hemal Gada, Mubashir Mumtaz, Basel Ramlawi, Tanvir Bajwa, John Crouch, Paul S Teirstein, Neal S Kleiman, Ayman Iskander, Rodrigo Bagur, Michael W A Chu, Pierre Berthoumieu, Arnaud Sudre, Rik Adrichem, Saki Ito, Jian Huang, Jeffrey J Popma, John K Forrest, Michael J Reardon\",\"doi\":\"10.1161/CIRCINTERVENTIONS.124.014018\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.</p><p><strong>Methods: </strong>The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.</p><p><strong>Results: </strong>In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (<i>P</i>=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; <i>P</i>=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; <i>P</i><0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, <i>P</i>=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (<i>P</i><0.001) and lower rates of severe prosthesis-patient mismatch (<i>P</i><0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.</p><p><strong>Conclusions: </strong>Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.</p><p><strong>Registration: </strong>URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.</p>\",\"PeriodicalId\":10330,\"journal\":{\"name\":\"Circulation: Cardiovascular Interventions\",\"volume\":\" \",\"pages\":\"e014018\"},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11573113/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation: Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014018\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/18 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014018","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/18 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients.
Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.
Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.
Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.
Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.
期刊介绍:
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.