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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphilimus-eluting stents | Experimental | Polymer-free Amphilimus-eluting stents |
|
| Zotarolimus-eluting stents | Active Comparator | Biolinx Polymer-based zotarolimus-eluting stents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymer-free amphilimus-eluting stents | Device | Cre8 Evo coronary stent system (CID, Saluggia, Italy) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | 12 and 24 months | |
| Target vessel myocardial infarction | 12 and 24 months | |
| Target vessel revascularization |
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Inclusion Criteria(must meet all):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | ||
| Hospital General Universitario de Alicante |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32087418 | Result | 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. | |
| 40562528 |
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| Biolinx Polymer-based zotarolimus-eluting stents | Device | Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US) |
|
| 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 |
| Alicante |
| Spain |
| Hospital San Juan | Alicante | Spain |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Vall d'Hebrón | Barcelona | Spain |
| Hospital Reina Sofía | Córdoba | Spain |
| Hospital Juan Ramón Jiménez | Huelva | Spain |
| Hospital Doctor Negrín | Las Palmas de Gran Canaria | Spain |
| Hospital Universitario de León | León | Spain |
| Hospital Lucus Augusti | Lugo | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Clínica Universidad de Navarra | Madrid | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain |
| Hospital Marqués de Valdecilla | Santander | Spain |
| Hospital de Santiago | Santiago de Compostela | Spain |
| Hospital Joan XXIII | Tarragona | Spain |
| Hospital Virgen de la Salud | Toledo | Spain |
| Hospital Clínico de Valencia | Valencia | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Spain |
| Derived |
| Salinas P, Romaguera R, Gomez-Lara J, Brugaletta S, Gomez-Menchero A, Martin P, Romero M, Garcia-Blas S, Jimenez M, Jimenez VA, Bordes P, Bayon J, Salvatella N, Alameda M, Hyun-Lee D, Trillo-Nouche R, Lopez-Benito M, Frutos A, Moreu J, Garcia Del Blanco B, Mohandes M, Bosa Ojeda F, Hernandez Hernandez F, Pinar-Bermudez E, Jimenez-Quevedo P, Rossello X, Pocock S, Sabate M, Gomez-Hospital JA, Comin-Colet J, Gonzalo N, Fernandez Ortiz A; SUGAR trial Investigators. Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial. Heart. 2025 Nov 25;111(24):1191-1198. doi: 10.1136/heartjnl-2025-325773. |
| 34735004 | Derived | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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