TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale.

Autor: Kedhi E; McGill University Health Center, Montreal, Quebec, Canada; Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland. Electronic address: ekedhi@me.com., Rroku A; Department of Cardiology, Deutsches Herzzentrum der Charité, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany., Hermanides RS; Isala Heart Center, Department of Cardiology, Zwolle, The Netherlands., Dambrink JH; Isala Heart Center, Department of Cardiology, Zwolle, The Netherlands., Singh S; Isala Heart Center, Department of Thoracic Surgery, Zwolle, The Netherlands., Berg JT; St.Antonius Ziekenhuis, Nieuwegein, The Netherlands and University Medical Center Maastricht, Maastricht, The Netherlands., van Ginkel DJ; St.Antonius Ziekenhuis, Nieuwegein, The Netherlands and University Medical Center Maastricht, Maastricht, The Netherlands., Hudec M; SÚSCCH, A.S. Banská, Bystrica, Slovak Republic., Amoroso G; Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands., Amat-Santos IJ; Centro de Investigación Biomdica en Red, Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Andreas M; Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria., Teles RC; Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal., Bonnet G; Medico-Surgical Department (Valvulopathies, Cardiac Surgery, Adult Interventional Cardiology), Hôpital Cardiologique de Haut-Lévèque, Bordeaux University Hospital, France., Van Belle E; CHU Lille, Department of Cardiology, Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Institut Coeur Puomon, Inserm, U1011, Institut Pasteur de Lille, EGIG, Université de Lille, Lille, France., Conradi L; Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Germany., van Garsse L; Department of Cardiothoracic Surgery, Radboud University Medical Centre, The Netherlands., Wojakowski W; Department of Cardiology and Structural Heart Disease, Medical Univ. Silesia, Katowice, Poland., Voudris V; Interventional Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece., Sacha J; Department of Cardiology, University Hospital, Institute of Medical Sciences, University of Opole, Opole, Poland; Faculty of Physical Education and Physiotherapy, Opole University of Technology, Opole, Poland., Cervinka P; Department of Cardiology, Krajska Zdravotni A.S., Masaryk Hospital and UJEP Usti nad Labem, Czech Republic., Lipsic E; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Somi S; Department of Cardiology, Haga Hospital, The Hague, The Netherlands., Nombela-Franco L; Cardiovascular Institute, Hospital Clínico San Carlos IdISSC, Madrid, Spain., Postma S; Diagram Research, Zwolle, The Netherlands., Piayda K; Department of Cardiology and Vascular Medicine, Medical Faculty, Justus-Liebig-University Giessen, Giessen, Germany., De Luca G; Division of Clinical and Experimental Cardiology, AOU Sassari, University of Sassari, Sassari, Italy., Malinofski K; Center for Digital Medicine and Robotics, Jagiellonian University Medical College, Kraków, Poland; Department of Bioinformatics and Telemedicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland., Modine T; Medico-Surgical Department (Valvulopathies, Cardiac Surgery, Adult Interventional Cardiology), Hôpital Cardiologique de Haut-Lévèque, Bordeaux University Hospital, France.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2024 Apr; Vol. 270, pp. 86-94. Date of Electronic Publication: 2024 Feb 01.
DOI: 10.1016/j.ahj.2024.01.010
Abstrakt: Background: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD.
Aims: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD.
Methods: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis.
Summary: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).
Competing Interests: Conflict of interest E.K. reports institutional research grants support from Abbott Vascular Laboratories and Medtronic as well as proctor/lecture fees from Abbott Vascular. R.H. reports lecture fees from Abbott Vascular, Amgen, Novartis. M.H. reports proctor for Meril Life. I.A.S. reports proctor for Boston Scientific, Medtronic and Meril Life. M.A. reports proctor/speaker/consultant fees from Edwards, Abbott, Medtronic, Boston, Zoll, Abbvie and received institutional research grants Edwards, Abbott, Medtronic, LSI. L.C: Advisory Board member for Abbott, Medtronic and JenaValve, consultant for Edwards Lifesciences, Boston Scientific, PiCardia, MicroPort, MicroInterventions. W. Wojakowski: Medtronic advisory board, lecture fees from Edwards Lifesciences, Abbott, Medtronic; E.L.Institutional Research from Abbott Medical Netherlands. All other authors don't report any conflict of interest.
(Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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