Clinical trial NCT03424941: The TransCatheter Valve and Vessels Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Multi Vessel Coronary Artery Disease
TAVI
CABG
PCI
Fractional Flow Reserve
Keywords: Aortic Stenosis (AS)
Multi Vessel Coronary Artery Disease (MVD)
TransCatheter Aortic Valve Implantation (TAVI)
Coronary Artery By-pass Grafting (CABG)
Percutaneous Coronary Intervention (PCI)
Fractional Flow Reserve (FFR)
Surgical Aortic Valve Replacement (SAVR)
Lead sponsor: Maatschap Cardiologie Zwolle
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2018-02-07
Enrollment: 172
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: one year
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year
timeFrame: one year
measure: All-cause mortality and all stroke at 30 days and at one year
timeFrame: 30 days and one year
measure: Life-threatening or disabling bleeding at 30 days and one year
timeFrame: 30 days and one year
measure: Life-threatening or disabling bleeding and major bleeding at 30 days and at one year
timeFrame: 30 days and one year
measure: Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year
timeFrame: 30 days and one year
measure: Access-related complications at 30 days
timeFrame: 30 days
measure: Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year
timeFrame: 30 days and one year
measure: Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year
timeFrame: 30 days and one year
measure: Device success (Valve Academic Research Consortium (VARC) 2 definition)
timeFrame: procedure
measure: Early Safety at 30 days (VARC 2 definition)
timeFrame: 30 days
measure: Early Efficacy at 30 days (VARC 2 definition)
timeFrame: 30 days
measure: Time Related Valve Safety at 30 days (VARC 2 definition)
timeFrame: 30 days
measure: 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
timeFrame: discharge and at one year
measure: Clinically driven revascularisation at 30 days and at one year
timeFrame: 30 days and one year
measure: Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year
timeFrame: 30 days and one year
measure: Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year
timeFrame: 30 days and one year
measure: Quality of life (Short Form (SF)-36) before treatment and at one year
timeFrame: one year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Vienna
country: Austria
facility: General Hospital Vienna
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Lille
country: France
facility: CHRU de Lille
city: Toulouse
country: France
facility: Clinique Pasteur
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH
city: Kallithéa
country: Greece
facility: Onassis Cardiac Surgery Center
city: Amsterdam
country: Netherlands
facility: OLVG
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis
city: Groningen
country: Netherlands
facility: UMCG
city: Nieuwegein
country: Netherlands
facility: St. Antonius hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: The Hague
country: Netherlands
facility: HagaZiekenhuis
city: Zwolle
country: Netherlands
facility: Isala hospital
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Opole
country: Poland
facility: University hospital Opole
city: Lisboa
country: Portugal
facility: Hospital de Santa Cruz
city: Banská Bystrica
country: Slovakia
facility: SUSCCH
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Valladolid
country: Spain
facility: Hospital Clínico Valladolid
Study officials:
affiliation: Hopital Erasme, Brussels, Belgium
name: prof. Elvin Kedhi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: