Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.
Prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial
If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 1:1 fashion between FFR-guided PCI + TAVI and CABG + SAVR.
Patients will receive optimal medical treatment at discharge. Follow-up will be performed at 30 days and at one year. During the 30 day follow-up visit (after TAVI) patients will be evaluated for symptoms of angina.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR-guided PCI and TAVI | Experimental | FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO |
|
| CABG and SAVR | Active Comparator | CABG and SAVR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR-guided PCI and TAVI | Device | Treatment of subjects with multivessel coronary artery disease and aortic stenosis for FFR-guided PCI and TAVI (Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO) |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year | one year | |
| All-cause mortality and all stroke at 30 days and at one year | 30 days and one year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| prof. Elvin Kedhi, MD, PhD | Hopital Erasme, Brussels, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Austria | ||||
| General Hospital Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39644913 | Derived | Kedhi E, Hermanides RS, Dambrink JE, Singh SK, Ten Berg JM, van Ginkel D, Hudec M, Amoroso G, Amat-Santos IJ, Andreas M, Campante Teles R, Bonnet G, Van Belle E, Conradi L, van Garsse L, Wojakowski W, Voudris V, Sacha J, Cervinka P, Lipsic E, Somi S, Nombela-Franco L, Postma S, Piayda K, De Luca G, Kolkman E, Malinowski KP, Modine T; TCW study group. 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 complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial. Lancet. 2025 Dec 21;404(10471):2593-2602. doi: 10.1016/S0140-6736(24)02100-7. Epub 2024 Dec 4. | |
| 38309610 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CABG and SAVR | Device | Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR |
|
| Life-threatening or disabling bleeding at 30 days and one year | 30 days and one year |
| Life-threatening or disabling bleeding and major bleeding at 30 days and at one year | 30 days and one year |
| Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year | 30 days and one year |
| Access-related complications at 30 days | 30 days |
| Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year | 30 days and one year |
| Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year | 30 days and one year |
| Device success (Valve Academic Research Consortium (VARC) 2 definition) | procedure |
| Early Safety at 30 days (VARC 2 definition) | 30 days |
| Early Efficacy at 30 days (VARC 2 definition) | 30 days |
| Time Related Valve Safety at 30 days (VARC 2 definition) | 30 days |
| Echocardiographic assessment of prosthetic valve performance at discharge and at one year using the following measures: a) transvalvular mean gradient, b) Effective Orifice Area (EOA), c) degree of prosthetic aortic valve regurgitation | discharge and at one year |
| Clinically driven revascularisation at 30 days and at one year | 30 days and one year |
| Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year | 30 days and one year |
| Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year | 30 days and one year |
| Quality of life (Short Form (SF)-36) before treatment and at one year | one year |
| Vienna |
| Austria |
| Rigshospitalet, Copenhagen University Hospital | Copenhagen | Denmark |
| CHU de Bordeaux | Bordeaux | France |
| CHRU de Lille | Lille | France |
| Clinique Pasteur | Toulouse | France |
| Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH | Hamburg | Germany |
| Onassis Cardiac Surgery Center | Kallithea | Greece |
| OLVG | Amsterdam | Netherlands |
| UMCG | Groningen | Netherlands |
| St. Antonius hospital | Nieuwegein | Netherlands |
| Radboudumc | Nijmegen | Netherlands |
| Hagaziekenhuis | The Hague | Netherlands |
| Isala hospital | Zwolle | Netherlands |
| Medical University of Silesia | Katowice | Poland |
| University hospital Opole | Opole | Poland |
| Hospital de Santa Cruz | Lisbon | Portugal |
| SUSCCH | Banská Bystrica | Slovakia |
| Hospital Clinico Universitario San Carlos | Madrid | Spain |
| Hospital Clínico Valladolid | Valladolid | Spain |
| Derived |
| Kedhi E, Rroku A, Hermanides RS, Dambrink JH, Singh S, Berg JT, van Ginkel DJ, Hudec M, Amoroso G, Amat-Santos IJ, Andreas M, Teles RC, Bonnet G, Van Belle E, Conradi L, van Garsse L, Wojakowski W, Voudris V, Sacha J, Cervinka P, Lipsic E, Somi S, Nombela-Franco L, Postma S, Piayda K, De Luca G, Malinofski K, Modine T. 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. Am Heart J. 2024 Apr;270:86-94. doi: 10.1016/j.ahj.2024.01.010. Epub 2024 Feb 1. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
Not provided
Not provided