Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial: Rationale and study design
Por:
Romaguera, R, Salinas, P, Brugaletta, S, Gomez-Lara, J, Diaz, J, Romero, M, Garcia-Blas, S, Ocaranza, R, Borde, P, Kockar, M, Segovia, R, Iniguez, A, Alameda, M, Trillo, R, Lee, D, Martin, P, Lopez-Benito, M, Frutos, A, Moreu, J, Hernandez-Hernandez, F, del Blanco, B, Roura, G, Rossello, X, Pocock, S, Fernandez-Ortiz, A, Sabate, M and Gomez-Hospital, J
Publicada:
1 abr 2020
Categoría:
Cardiology and cardiovascular medicine
Resumen:
Aim 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 amphili m us (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.
Conclusions SUGAR is the first randomized head-to head trial comparing second-generation DES in an all-comer diabetic population undergoing PCI.
Filiaciones:
Romaguera, R:
Univ Barcelona, Hosp Bellvitge IDIBELL, Barcelona, Spain
Salinas, P:
Hosp Clin San Carlos, Madrid, Spain
Hosp Clin San Carlos IdISSC, Inst Invest Sanit, Madrid, Spain
Brugaletta, S:
Univ Barcelona, Hosp Clin, Barcelona, Spain
Gomez-Lara, J:
Univ Barcelona, Hosp Bellvitge IDIBELL, Barcelona, Spain
Diaz, J:
Hosp Juan Ramon Jimenez, Huelva, Spain
Romero, M:
Hosp Reina Sofia, Cordoba, Spain
Garcia-Blas, S:
Hosp Clin Univ, Valencia, Spain
Ocaranza, R:
Hosp Lucus Augusti, Lugo, Spain
Borde, P:
Hosp Gen Univ, Alicante, Spain
Kockar, M:
Hosp Santa Creu i St Pau, Barcelona, Spain
Segovia, R:
Hosp Mar, Barcelona, Spain
Iniguez, A:
Hosp Alvaro Cunqueiro, Vigo, Spain
Alameda, M:
Hosp Univ Son Espases, Mallorca, Spain
Trillo, R:
Hosp Santiago, Santiago De Compostela, Spain
Lee, D:
Hosp Marques Valdecilla, Santander, Spain
Martin, P:
Hosp Doctor Negrin, Gran Canaria, Spain
Lopez-Benito, M:
Hosp Univ Leon, Leon, Spain
:
Hosp San Juan, Alicante, Spain
Moreu, J:
Hosp Virgen Salud, Toledo, Spain
Hernandez-Hernandez, F:
Clin Univ Navarra, Madrid, Spain
del Blanco, B:
Hosp Valle De Hebron, Barcelona, Spain
Roura, G:
Univ Barcelona, Hosp Bellvitge IDIBELL, Barcelona, Spain
Rossello, X:
CNIC, Clin Trials Coordinat Unit, Madrid, Spain
Pocock, S:
London Sch Hyg & Trop Med, Dept Biostat, London, England
Fernandez-Ortiz, A:
Hosp Clin San Carlos, Madrid, Spain
Hosp Clin San Carlos IdISSC, Inst Invest Sanit, Madrid, Spain
Sabate, M:
Univ Barcelona, Hosp Clin, Barcelona, Spain
Gomez-Hospital, J:
Univ Barcelona, Hosp Bellvitge IDIBELL, Barcelona, Spain
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