The TransCatheter Valve and Vessels Trial

NCT ID: NCT03424941

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2024-06-26

Brief Summary

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.

Detailed Description

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.

Conditions

Aortic Stenosis; Multi Vessel Coronary Artery Disease; TAVI; CABG; PCI; Fractional Flow Reserve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FFR-guided PCI and TAVI

FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO

Group Type: EXPERIMENTAL

FFR-guided PCI and TAVI

Intervention Type: 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)

CABG and SAVR

CABG and SAVR

Group Type: ACTIVE_COMPARATOR

CABG and SAVR

Intervention Type: DEVICE

Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR

Interventions

FFR-guided PCI and TAVI

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)

Intervention Type: DEVICE

CABG and SAVR

Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Symptomatic patients aged ≥70 years with aortic stenosis fulfilling one of these criteria (Aortic Valve Area (AVA) ≤1 cm2; mean gradient ≥40 mmHg; Aortic jet velocity >4 m/sec; or Velocity index ≤ 0.25) feasible for treatment by both trans femoral or subclavian approach TAVI as well as conventional SAVR and where the Heart Team decides that treatment is needed (final decision is left to the Heart Team)

2. Presence of ≥2 de novo coronary lesions of ≥50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries, or side branches of a lumen caliber of more than 2 mm or single Left Anterior Descending (LAD) lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (Heart Team decision)

3. Patients willing and capable to provide written informed consent

Exclusion Criteria

1. Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics <48 hours before procedure

2. Left ventricular ejection fraction <30%

3. Concomitant presence of other than aortic valve disease requiring intervention

4. Previous CABG, SAVR, TAVI or thoracotomy for any other reason

5. Bicuspid or unicuspid aortic valve

6. Recent myocardial infarction (less than 2 weeks)

7. Involvement of left main trifurcation (all three branches being larger than 2 mm)

8. Expected total stent length more 60mm per vessel

9. FFR measurement judged impossible

10. Life expectancy <1 year

11. Known malignancy

12. Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months

13. Reduced renal function (Glomerular Filtration Rate (GFR) <29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)

14. Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries

15. Participation in other investigational clinical trials

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Maatschap Cardiologie Zwolle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

prof. Elvin Kedhi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Erasme, Brussels, Belgium

Locations

Medical University of Graz

Graz, , Austria

General Hospital Vienna

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

Countries

Austria; Denmark; France; Germany; Greece; Netherlands; Poland; Portugal; Slovakia; Spain

References

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.

Reference Type: DERIVED

PMID: 39644913 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38309610 (View on PubMed)

Other Identifiers

9283

Identifier Type: -

Identifier Source: org_study_id