Second-generation Drug-eluting Stents in Diabetes

Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)

This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology.

It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design.

The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).

Inclusion Criteria(must meet all):

• Patients ≥18 years who understands the nature of the study and provides written informed consent.
• Diagnosis of diabetes according to the American Diabetes Association diagnostic criteria (*)
• Documented silent ischemia, stable angina, unstable angina, or myocardial infarction (with or without ST elevation).
• At least one de novo coronary lesion with stenosis of more than 50% in a vessel with a reference vessel diameter of 2.25 to 4.5 mm by visual estimation. Coronary anatomy is suitable for PCI (patients with potential CABG indication should be eligible for PCI after a multidisciplinary evaluation in a Heart Team).

Exclusion Criteria:

• Cardiogenic shock or resuscitation
• Comorbidity with anticipated life expectancy to 24 months
• Inability to consent due to mechanical ventilation
• Pregnant female patient
• Conditions that could preclude a minimal of 1 month of DAPT (such as, but not limited to: severe liver failure, platelet count <100,000 cells/mm3, recent gastrointestinal bleeding or history of bleeding diathesis or coagulopathy)
• Contraindication or known allergy to aspirin, heparin, P2Y12 inhibitors, cobalt and/or chromium metal alloys, sirolimus or derivates, polyurethane, or contrast media (for contrast-media allergy, patients that might be safely and adequately pre-medicated should be allowed to enter the study).
• Currently enrolled in another clinical trial.