The TransCatheter Valve and Vessels Trial (TCW)

TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients With Coronary MultiVessel Disease and Aortic Valve Stenosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: CABG; Aortic Stenosis; Fractional Flow Reserve; PCI; Multi Vessel Coronary Artery Disease; TAVI
• Intervention / Treatment: Device: FFR-guided PCI and TAVI; Device: CABG and SAVR

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonja Postma, PhD; Phone Number: +31 384262999; Email: TCW.trial@diagram-zwolle.nl

Study Locations

• Austria
  • Graz, Austria
    • Medical University of Graz
  • Vienna, Austria
    • General Hospital Vienna
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet, Copenhagen University Hospital
• France
  • Bordeaux, France
    • CHU de Bordeaux
  • Lille, France
    • CHRU de Lille
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Hamburg, Germany
    • Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH
• Greece
  • Kallithéa, Greece
    • Onassis Cardiac Surgery Center
• Netherlands
  • Amsterdam, Netherlands
    • OLVG
  • Den Haag, Netherlands
    • HagaZiekenhuis
  • Groningen, Netherlands
    • UMCG
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
  • Nijmegen, Netherlands
    • Radboudumc
  • The Hague, Netherlands
    • HagaZiekenhuis
  • Zwolle, Netherlands
    • Isala hospital
• Poland
  • Katowice, Poland
    • Medical University of Silesia
  • Opole, Poland
    • University hospital Opole
• Portugal
  • Lisboa, Portugal
    • Hospital de Santa Cruz
• Slovakia
  • Banská Bystrica, Slovakia
    • SUSCCH
• Spain
  • Madrid, Spain
    • Hospital Clínico Universitario San Carlos
  • Valladolid, Spain
    • Hospital Clínico Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FFR-guided PCI and TAVI; FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO	Device: 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)
Active Comparator: CABG and SAVR	Device: CABG and SAVR; Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Maatschap Cardiologie Zwolle
• Collaborators: Medtronic
• Investigators: Principal Investigator: prof. Elvin Kedhi, MD, PhD, Hopital Erasme, Brussels, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Fractional Flow Reserve (FFR); Percutaneous Coronary Intervention (PCI); Surgical Aortic Valve Replacement (SAVR); Aortic Stenosis (AS); Multi Vessel Coronary Artery Disease (MVD); TransCatheter Aortic Valve Implantation (TAVI); Coronary Artery By-pass Grafting (CABG)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 9283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No