Second-generation Drug-eluting Stents in Diabetes

Study Overview
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Brief Summary
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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).

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

Conditions
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Coronary Artery Disease, Diabetes Mellitus

Intervention / Treatment
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* Device: Polymer-free amphilimus-eluting stents
* Device: Biolinx Polymer-based zotarolimus-eluting stents


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amphilimus-eluting stents<br>Polymer-free Amphilimus-eluting stents | Device: Polymer-free amphilimus-eluting stents<br>* Cre8 Evo coronary stent system (CID, Saluggia, Italy)<br>|
| Active Comparator: Zotarolimus-eluting stents<br>Biolinx Polymer-based zotarolimus-eluting stents | Device: Biolinx Polymer-based zotarolimus-eluting stents<br>* Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure at 1-year follow-up | A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 12-months follow-up. | 12 months | 
| Target lesion failure at 2-years follow-up | A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 24-months follow-up. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 12 and 24 months | 
| Target vessel myocardial infarction |  | 12 and 24 months | 
| Target vessel revascularization |  | 12 and 24 months | 
| Target lesion revascularization |  | 12 and 24 months | 
| Stent thrombosis | Academic Research Consortium definitions | 12 and 24 months | 
| Non-target lesion revascularization |  | 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stents, Coronary Artery Disease, Diabetes Mellitus, Restenosis