Second-generation Drug-eluting Stents in Diabetes (SUGAR)

Spanish Society of Cardiology

Status and phase

Unknown

Phase 4

Conditions

Coronary Artery Disease

Diabetes Mellitus

Treatments

Device: Biolinx Polymer-based zotarolimus-eluting stents

Device: Polymer-free amphilimus-eluting stents

Study type

Interventional

Funder types

Other

Identifiers

NCT03321032

SEC-SUG-2016-01

Details and patient eligibility

About

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).

Enrollment

1,164 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.