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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
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)
Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR
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
...and 10 more locations
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
Time frame: 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
Time frame: one year
All-cause mortality and all stroke at 30 days and at one year
Time frame: 30 days and one year
Life-threatening or disabling bleeding at 30 days and one year
Time frame: 30 days and one year
Life-threatening or disabling bleeding and major bleeding at 30 days and at one year
Time frame: 30 days and one year
Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year
Time frame: 30 days and one year
Access-related complications at 30 days
Time frame: 30 days
Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year
Time frame: 30 days and one year
Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year
Time frame: 30 days and one year
Device success (Valve Academic Research Consortium (VARC) 2 definition)
Time frame: procedure
Early Safety at 30 days (VARC 2 definition)
Time frame: 30 days
Early Efficacy at 30 days (VARC 2 definition)
Time frame: 30 days
Time Related Valve Safety at 30 days (VARC 2 definition)
Time frame: 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
Time frame: discharge and at one year
Clinically driven revascularisation at 30 days and at one year
Time frame: 30 days and one year
Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year
Time frame: 30 days and one year
Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year
Time frame: 30 days and one year
Quality of life (Short Form (SF)-36) before treatment and at one year
Time frame: one year
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