Multivessel TALENT

Sponsor: National University of Ireland Galway

This is a prospective, randomized, 1:1, controlled, multi-centre, angiographically documented three-vessel disease (3VD) open-label study comparing clinical outcomes between SUPRAFLEX Cruz and SYNERGY in approximately 1550 patients.

Patients with de-novo 3VD will be treated according to ‘state of art PCI’ including:

1)      SYNTAX score II recommendation (i.e., PCI only or equipoise CABG/PCI);
2)      Heart Team discussion (ESC guidelines: IC);
3)      Functional evaluation for diagnosis in absence of objective evidence of ischemia (ESC guidelines: IA) (i.e., quantitative flow ratio); post-procedure IVUS/OCT optimization (ESC guidelines: IIa B);
4)      Contemporary CTO techniques;
5)      Optimal medical therapy (P2Y12 inhibitor, statin, etc). All patients must receive dual anti-platelet therapy, being aspirin (ASA) and prasugrel for 1 month, followed by 11 months of prasugrel only (i.e. monotherapy).

The Primary Endpoint for this trial is a non-inferiority comparison of Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEX Cruz cohort to the SYNERGY cohort at 12 months post-procedure. POCE is a composite clinical endpoint of:

–          all-cause death;
–          any stroke, modified Rankin Scale (mRS ≥ 1);
–          any myocardial infarction (MI); any (repeat) revascularization.

Study Team:
SI: drs. C.S. Venema
Project coordinator: G.H. de Jong