The TransCatheter Valve and Vessels Trial

Not Applicable

Completed

• Conditions: Aortic Stenosis; Fractional Flow Reserve; Multi Vessel Coronary Artery Disease; PCI; CABG; TAVI
• Interventions: Device: FFR-guided PCI and TAVI; Device: CABG and SAVR

• Registration Number: NCT03424941
• Lead Sponsor: Maatschap Cardiologie Zwolle

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.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2018-05-31
• Primary Completion: 2024-06-26
• Study Completion: 2024-06-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFR-guided PCI and TAVI	FFR-guided PCI and TAVI	FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO
CABG and SAVR	CABG and SAVR	CABG and SAVR

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
All-cause mortality and all stroke at 30 days and at one year	30 days and one year
Device success (Valve Academic Research Consortium (VARC) 2 definition)	procedure
Quality of life (Short Form (SF)-36) before treatment and at one year	one year
Life-threatening or disabling bleeding at 30 days and one year	30 days and one year
Access-related complications at 30 days	30 days
Early 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
Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year	30 days and one year
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
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
Time Related Valve Safety at 30 days (VARC 2 definition)	30 days
Clinically driven revascularisation 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
Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at 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
Early Efficacy at 30 days (VARC 2 definition)	30 days

Trial Locations

Locations (21)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH; 🇩🇪 Hamburg, Germany

OLVG; 🇳🇱 Amsterdam, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands

CHRU de Lille; 🇫🇷 Lille, France

Hospital Clinico Universitario San Carlos; 🇪🇸 Madrid, Spain

Hagaziekenhuis; 🇳🇱 Den Haag, Netherlands

Hospital Clínico Valladolid; 🇪🇸 Valladolid, Spain

Clinique Pasteur; 🇫🇷 Toulouse, France

Isala hospital; 🇳🇱 Zwolle, Netherlands

HagaZiekenhuis; 🇳🇱 The Hague, Netherlands

University hospital Opole; 🇵🇱 Opole, Poland

General Hospital Vienna; 🇦🇹 Vienna, Austria

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark

UMCG; 🇳🇱 Groningen, Netherlands

St. Antonius hospital; 🇳🇱 Nieuwegein, Netherlands

Onassis Cardiac Surgery Center; 🇬🇷 Kallithéa, Greece

Hospital de Santa Cruz; 🇵🇹 Lisboa, Portugal

Medical University of Graz; 🇦🇹 Graz, Austria

Medical University of Silesia; 🇵🇱 Katowice, Poland

SUSCCH; 🇸🇰 Banská Bystrica, Slovakia