Study Details
Overview
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
Dual Antiplatelet Therapy arm (1:1): Ticagrelor + Aspirin vs Prasugrel + Aspirin - Treatment → Guideline-directed Medical Therapy + Percutaneous Coronary Intervention with image-/physiology-guided complete revascularization (where feasible).
- Follow-up → 1 year (primary), annually up to 5 years.
- Endpoints
- Primary (Stent arm): Target lesion failure 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: CAD: Coronary Artery Disease, PCI: Percutaneous Coronary Intervention, DAPT: Dual Antiplatelet Therapy, MI: Myocardial Infarction, MACE: Major Adverse Cardiac Events, BARC: Bleeding Academic Research Consortium, NI: Non-Inferiority