Coronary Artery Disease, Diabetes Mellitus
Conditions
Keywords
Coronary Artery Disease, Diabetes Mellitus, Drug-eluting stents, Restenosis
Brief summary
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).
Interventions
DEVICEPolymer-free amphilimus-eluting stents
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
DEVICEBiolinx Polymer-based zotarolimus-eluting stents
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)
Sponsors
Spanish Society of Cardiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure at 2-years follow-up | 24 months | 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. |
| Target lesion failure at 1-year follow-up | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel revascularization | 12 and 24 months | — |
| Target lesion revascularization | 12 and 24 months | — |
| Cardiac death | 12 and 24 months | — |
| Non-target lesion revascularization | 12 and 24 months | — |
| Stent thrombosis | 12 and 24 months | Academic Research Consortium definitions |
| Target vessel myocardial infarction | 12 and 24 months | — |
Countries
Spain
Outcome results
None listed