Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial: Rationale and study design
Romaguera R 1, Salinas P 2, Brugaletta S 3, Gomez-Lara J 4, Díaz JF 5, Romero MA 6, García-Blas S 7, Ocaranza R 8, Borde P 9, Jiménez Kockar M 10, Millan Segovia R 11, Íñiguez A 12, Alameda M 13, Trillo R 14, Lee DH 15, Martín P 16, López-Benito M 17, Frutos A 18, Moreu J 19, Hernández-Hernández F 20, García Del Blanco B 21, Roura G 4, Rossello X 22, Pocock SJ 23, Fernández-Ortiz A 2, Sabate M 3, Gómez-Hospital JA 4.
1 Hospital de Bellvitge - IDIBELL, University of Barcelona, Barcelona, Spain.
2 Hospital Clínico San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
3 Hospital Clinic, University of Barcelona, Barcelona, Spain.
4 Hospital de Bellvitge - IDIBELL, University of Barcelona, Barcelona, Spain.
5 Hospital Juan Ramón Jiménez, Huelva, Spain.
6 Hospital Reina Sofía, Córdoba, Spain.
7 Hospital Clínico Universitario, Valencia, Spain.
8 Hospital Lucus Augusti, Lugo, Spain.
9 Hospital General Universitario, Alicante, Spain.
10 Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
11 Hospital del Mar, Barcelona, Spain.
12 Hospital Álvaro Cunqueiro, Vigo, Spain.
13 Hospital Universitario Son Espases, Mallorca, Spain.
14 Hospital de Santiago, Santiago de Compostela, Spain.
15 Hospital Marqués de Valdecilla, Santander, Spain.
16 Hospital Doctor Negrín, Gran Canaria, Spain.
17 Hospital Universitario de León, León, Spain.
18 Hospital San Juan, Alicante, Spain.
19 Hospital Virgen de la Salud, Toledo, Spain.
20 Clínica Universidad de Navarra, Madrid, Spain.
21 Hospital Vall d'Hebrón, Barcelona, Spain.
22 Clinical Trials Coordination Unit, Centro Nacional de Investigaciones Cardiovaculares (CNIC), Madrid, Spain.
23 Department of Biostatistics, London, School of Hygiene & Tropical Medicine, London, UK.
Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain at high risk of cardiovascular events despite the use of contemporary drug-eluting stents (DES). This trial aim to compare the clinical efficacy of 2 novel second-generation DES in patients with DM.
Methods and results
The Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial (ClinicalTrials.gov NCT03321032) is an investigator-initiated, prospective, randomized, controlled, multicenter study conducted exclusively in patients with DM. This study allows inclusion of the entire spectrum of patients with DM undergoing PCI, and the only exclusion criteria are shock at presentation, inability to consent or a life expectancy <2 years.
A total of 1164 patients will be randomized (1:1, no stratification) at 23 sites in Spain to treatment with polymer-free amphilimus (sirolimus formulated with an amphiphilic carrier) eluting stents versus Onyx-zotarolimus-eluting stents (Biolynx durable polymer and struts with platinum-iridium alloy core). Randomization will be patient-level, so in case of multivessel disease all lesions will be treated with the same stent.
The primary end point is target lesion failure, a composite of cardiac death, target vessel–related myocardial infarction, or clinically indicated target lesion revascularization. First co-primary analysis will test non-inferiority at 1 year (80% power, a non-inferiority margin of 4% (1.5 RR) and a type-I-error of 0.05.) and second co-primary analysis will test superiority at 2 years (80% power, 0.05 alpha). Enrollment commenced in December 2017, and inclusion is expected to be completed by December 2019.
SUGAR is the first randomized head-to head trial comparing second-generation DES in an all-comer diabetic population undergoing PCI.
CITA DEL ARTÍCULO Am Heart J. 2020 Jan 28;222:174-182. doi: 10.1016/j.ahj.2020.01.018