The TransCatheter Valve and Vessels Trial

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.

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.

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