Multivessel TALENT Trial

A randomized controlled trial to compare the safety and efficacy of siroliMUs-eLuTIng biodegradable polymer ulTrA-thin stent (Supraflex Cruz) and everolimus-eLuting biodegradable polymer stent (Synergy) in treatmENT for three-vessel coronary artery disease: Multivessel TALENT

Objective of the Study:

Primary Objective: To compare the SUPRAFLEX CRUZ sirolimus-eluting stent (SES) with the SYNERGY everolimus-eluting stent (EES) with respect to Patient-oriented Composite Endpoint (POCE: composite of all-cause death, any stroke, any MI, and any clinically and physiologically-indicated revascularization) at 12 months in a 3-vessel disease population (non-inferiority)

Secondary objectives: To compare the SUPRAFLEX CRUZ SES with the SYNERGY EES with respect to Vessel-oriented Composite Endpoint (VOCE, composite of vessel-related cardiovascular death, vessel-related MI, clinically and physiologically-indicated-Target vessel revascularization) per vessel at 24 months in a 3-vessel disease population (superiority)

Primary Endpoint:

Non-inferiority comparison of Patient-oriented Composite Endpoint (POCE) 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

Secondary Endpoint:

Superiority comparison (per vessel level) of the
Vessel-oriented Composite Endpoints (VOCE) at 24 months post-procedure.

VOCE is a composite of
– vessel-related cardiovascular death,
– vessel-related MI, or
– clinically and physiologically-indicated target vessel revascularization (CPI-TVR)