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).

Cardiovascular Institute Hospital Clínico San Carlos IdISSC Madrid Spain

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

Centro de Investigación Biomdica en Red Enfermedades Cardiovasculares Madrid Spain; Hospital Clínico Universitario de Valladolid Valladolid Spain

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

Department of Cardiac Surgery Medical University of Vienna Vienna Austria

Department of Cardiology and Structural Heart Disease Medical Univ Silesia Katowice Poland

Department of Cardiology and Vascular Medicine Medical Faculty Justus Liebig University Giessen Giessen Germany

Department of Cardiology Deutsches Herzzentrum der Charité Charité Universitätsmedizin Berlin corporate member of Freie Universität Berlin and Humboldt Universität zu Berlin Berlin Germany; DZHK Berlin Germany

Department of Cardiology Haga Hospital The Hague The Netherlands

Department of Cardiology Krajska Zdravotni A S Masaryk Hospital and UJEP Usti nad Labem Czech Republic

Department of Cardiology Onze Lieve Vrouwe Gasthuis Amsterdam The Netherlands

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

Department of Cardiology University Medical Center Groningen University of Groningen Groningen The Netherlands

Department of Cardiothoracic Surgery Radboud University Medical Centre The Netherlands

Department of Cardiovascular Surgery University Heart and Vascular Center Hamburg Germany

Diagram Research Zwolle The Netherlands

Division of Clinical and Experimental Cardiology AOU Sassari University of Sassari Sassari Italy

Hospital de Santa Cruz Centro Hospitalar de Lisboa Ocidental Lisbon Portugal

Interventional Department of Cardiology Onassis Cardiac Surgery Center Athens Greece

Isala Heart Center Department of Cardiology Zwolle The Netherlands

Isala Heart Center Department of Thoracic Surgery Zwolle The Netherlands

McGill University Health Center Montreal Quebec Canada; Department of Cardiology and Structural Heart Disease Medical University of Silesia Katowice Poland

Medico Surgical Department Hôpital Cardiologique de Haut Lévèque Bordeaux University Hospital France

St Antonius Ziekenhuis Nieuwegein The Netherlands and University Medical Center Maastricht Maastricht The Netherlands

SÚSCCH A S Banská Bystrica Slovak Republic

References provided by Crossref.org

See more in PubMed

ClinicalTrials.gov
NCT03424941