A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial
Publikation: Beitrag in Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung
Beitragende
- Klinik für Innere Medizin und Kardiologie (am Herzzentrum)
- Universitätsspital Zürich
- Universitätsklinikum Carl Gustav Carus Dresden
- Universitätsklinikum Freiburg
- Erasmus University Medical Center
- Universitätsklinikum Frankfurt
- Deutsches Zentrum für Herz-Kreislaufforschung (DZHK)
- Klinikum der Ludwig-Maximilians-Universität (LMU) München
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) - Standort München
- Klinikum Klagenfurt am Wörthersee
- Katholisches Klinikum Bochum gGmbH
- Ospedale Mauriziano Umberto I
- Institut für Herzinfarktforschung
- Deutsches Herzzentrum München
- Technische Universität München
- University of Glasgow
Abstract
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.
Details
| Originalsprache | Englisch |
|---|---|
| Seiten (von - bis) | 104-113 |
| Seitenumfang | 10 |
| Fachzeitschrift | American heart journal |
| Jahrgang | 277 |
| Publikationsstatus | Veröffentlicht - Nov. 2024 |
| Peer-Review-Status | Ja |
Externe IDs
| Scopus | 85202680749 |
|---|
Schlagworte
Schlagwörter
- Female, Humans, Male, Aortic Valve Stenosis/surgery, Coronary Angiography, Coronary Artery Disease/surgery, Percutaneous Coronary Intervention/methods, Prospective Studies, Transcatheter Aortic Valve Replacement/methods, Treatment Outcome, Multicenter Studies as Topic, Randomized Controlled Trials as Topic