Study Details

Study Design

Prospective, open-label, multicenter, randomized 2 x 2 factorial designed study

Schematic

Screening/Eligibility → Patients with diabetes mellitus and multivessel disease with indication for revascularization
Randomization (2×2 factorial)
Stent arm (1:1): Supraflex Cruz vs Xience Family
DAPT arm (1:1): Ticagrelor + Aspirin vs Prasugrel + Aspirin
Treatment → Guideline-directed Medical Therapy + PCI with image-/physiology-guided complete revascularization (where feasible).
Follow-up → 1 year (primary), annually up to 5 years.
Endpoints
- Primary (Stent arm): TLF at 1 year (event rate 11%, NI margin 4.5%).
- Secondary (PCI vs CABG): MACE (death, nonfatal MI, stroke) at 1–5 years (performance goal 21.6%).
- Tertiary (DAPT arm): Composite of death, MI, stroke & BARC major bleeding at 1 year (event rate 15%, NI margin 5%).

Abbreviation: PCI – Percutaneous Coronary Intervention, DAPT – Dual Antiplatelet Therapy, CABG – Coronary Artery Bypass Grafting, MI – Myocardial Infarction, MACE – Major Adverse Cardiac Events, BARC – Bleeding Academic Research Consortium, NI – Non-inferiority, TLF – Target Lesion Failure, TV-MI – Target Vessel Myocardial Infarction, ID-TLR – Ischemia-Driven Target Lesion Revascularization, TVD – Triple Vessel Disease, DVD – Double Vessel Disease