Clinical trial NCT03321032: Second-generation Drug-eluting Stents in Diabetes
Official title: Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Diabetes Mellitus
Keywords: Coronary Artery Disease
Diabetes Mellitus
Drug-eluting stents
Restenosis
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 1164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Target lesion failure at 1-year follow-up
timeFrame: 12 months
measure: Target lesion failure at 2-years follow-up
timeFrame: 24 months
Secondary outcomes:
measure: Cardiac death
timeFrame: 12 and 24 months
measure: Target vessel myocardial infarction
timeFrame: 12 and 24 months
measure: Target vessel revascularization
timeFrame: 12 and 24 months
measure: Target lesion revascularization
timeFrame: 12 and 24 months
measure: Stent thrombosis
timeFrame: 12 and 24 months
measure: Non-target lesion revascularization
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Alicante
country: Spain
facility: Hospital San Juan
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Doctor Negrín
city: León
country: Spain
facility: Hospital Universitario de León
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital de Santiago
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
References:
citation: Romaguera R, Salinas P, Brugaletta S, Gomez-Lara J, Diaz JF, Romero MA, Garcia-Blas S, Ocaranza R, Borde P, Jimenez Kockar M, Millan Segovia R, Iniguez A, Alameda M, Trillo R, Lee DH, Martin P, Lopez-Benito M, Frutos A, Moreu J, Hernandez-Hernandez F, Garcia Del Blanco B, Roura G, Rossello X, Pocock SJ, Fernandez-Ortiz A, Sabate M, Gomez-Hospital JA. Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial: Rationale and study design. Am Heart J. 2020 Apr;222:174-182. doi: 10.1016/j.ahj.2020.01.018. Epub 2020 Jan 28. No abstract available.
citation: Romaguera R, Salinas P, Gomez-Lara J, Brugaletta S, Gomez-Menchero A, Romero MA, Garcia-Blas S, Ocaranza R, Bordes P, Kockar MJ, Salvatella N, Jimenez-Diaz VA, Alameda M, Trillo R, Lee DH, Martin P, Lopez-Benito M, Freites A, Pascual-Tejerina V, Hernandez-Hernandez F, Blanco BGD, Mohandes M, Bosa F, Pinar E, Roura G, Comin-Colet J, Fernandez-Ortiz A, Macaya C, Rossello X, Sabate M, Pocock SJ, Gomez-Hospital JA; SUGAR trial investigators. Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial. Eur Heart J. 2022 Mar 31;43(13):1320-1330. doi: 10.1093/eurheartj/ehab790.