Barbara E. Stähli MD, MPH, MBA , Axel Linke MD , Dirk Westermann MD , Nicolas M. Van Mieghem MD , David M. Leistner MD , Steffen Massberg MD , Hannes Alber MD , Andreas Mügge MD , Giuseppe Musumeci MD , Rahel Kesterke PhD , Steffen Schneider PhD , Adnan Kastrati MD , Ian Ford PhD , Frank Ruschitzka MD , Markus A. Kasel MD , TAVI PCI Investigators, Barbara E. Stähli , Markus Kasel , Frank Ruschitzka , Axel Linke , Aldo Maggioni
{"title":"经皮冠状动脉介入治疗与经导管主动脉瓣植入术治疗顺序的随机比较：TAVI PCI 试验的原理与设计。","authors":"Barbara E. Stähli MD, MPH, MBA , Axel Linke MD , Dirk Westermann MD , Nicolas M. Van Mieghem MD , David M. Leistner MD , Steffen Massberg MD , Hannes Alber MD , Andreas Mügge MD , Giuseppe Musumeci MD , Rahel Kesterke PhD , Steffen Schneider PhD , Adnan Kastrati MD , Ian Ford PhD , Frank Ruschitzka MD , Markus A. Kasel MD , TAVI PCI Investigators, Barbara E. Stähli , Markus Kasel , Frank Ruschitzka , Axel Linke , Aldo Maggioni","doi":"10.1016/j.ahj.2024.07.019","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown.</p></div><div><h3>Study design</h3><p>The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy “angiography-guided complete revascularization after (within 1-45 days) TAVI” is noninferior to the strategy “angiography-guided complete revascularization before (within 1-45 days) TAVI” using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year.</p></div><div><h3>Conclusions</h3><p>The TAVI PCI trial tests the hypothesis that the strategy “PCI after TAVI” is noninferior to the strategy “PCI before TAVI” in patients with severe aortic stenosis and concomitant coronary artery disease.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 104-113"},"PeriodicalIF":3.7000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial\",\"authors\":\"Barbara E. Stähli MD, MPH, MBA , Axel Linke MD , Dirk Westermann MD , Nicolas M. Van Mieghem MD , David M. Leistner MD , Steffen Massberg MD , Hannes Alber MD , Andreas Mügge MD , Giuseppe Musumeci MD , Rahel Kesterke PhD , Steffen Schneider PhD , Adnan Kastrati MD , Ian Ford PhD , Frank Ruschitzka MD , Markus A. Kasel MD , TAVI PCI Investigators, Barbara E. Stähli , Markus Kasel , Frank Ruschitzka , Axel Linke , Aldo Maggioni\",\"doi\":\"10.1016/j.ahj.2024.07.019\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown.</p></div><div><h3>Study design</h3><p>The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy “angiography-guided complete revascularization after (within 1-45 days) TAVI” is noninferior to the strategy “angiography-guided complete revascularization before (within 1-45 days) TAVI” using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. 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A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial
Background
About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown.
Study design
The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy “angiography-guided complete revascularization after (within 1-45 days) TAVI” is noninferior to the strategy “angiography-guided complete revascularization before (within 1-45 days) TAVI” using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year.
Conclusions
The TAVI PCI trial tests the hypothesis that the strategy “PCI after TAVI” is noninferior to the strategy “PCI before TAVI” in patients with severe aortic stenosis and concomitant coronary artery disease.
期刊介绍：
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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