Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial
| العنوان: | Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial |
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| المؤلفون: | Lara Fuentes, Pilar Jiménez-Quevedo, Guillem Muntané, Xavier Rossello, Bruno García del Blanco, Rafael Romaguera, Mar Alameda, María López-Benito, Gerard Roura, Eduardo Pinar, Montserrat Gracida, Josep Comín-Colet, Antonio Fernández-Ortiz, Marcelo Jiménez Kockar, Joan Antoni Gómez-Hospital, Neus Salvatella, Miguel Romero, Alfonso Freites, Virginia Pascual-Tejerino, Luis Ortega-Paz, Pablo Salinas, Francisco Bosa, José Luis Ferreiro, Stuart J. Pocock, Armando Pérez de Prado, Manel Sabaté, Mohsen Mohandes, Salvatore Brugaletta, Victor Alfonso Jimenez-Diaz, Antonio Gómez-Menchero, Angel Cequier, Josep Gomez-Lara, Sergio García-Blas, Carlos H. Salazar, Luis Teruel, José M. de la Torre Hernández, Dae-Hyun Lee, Pascual Bordes, Soledad Ojeda, Raymundo Ocaranza, Ramiro Trillo, Rocío Castillo-Poyo, Juan Sanchis, Felipe Hernández-Hernández, Carlos Macaya, Pedro Martín |
| المصدر: | EUROPEAN HEART JOURNAL r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA Consejo Superior de Investigaciones Científicas (CSIC) r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante instname Dipòsit Digital de la UB Universidad de Barcelona |
| بيانات النشر: | OXFORD UNIV PRESS, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, Revascularization, Malalties coronàries, Prosthesis Design, law.invention, Pròtesis de Stent, Percutaneous coronary intervention, Coronary artery disease, Coronary diseases, Clinical trials, Diabetes mellitus, Randomized controlled trial, law, Clinical endpoint, Medicine, Humans, Zotarolimus, Myocardial infarction, Drug-eluting stents, Sirolimus, Diabetis, business.industry, Diabetes, Stent, medicine.disease, equipment and supplies, Surgery, Treatment Outcome, Randomized trial, Cardiology and Cardiovascular Medicine, business, Stents (Surgery), medicine.drug, Assaigs clínics |
| الوصف: | Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44–0.96; P non-inferiority < 0.001; P superiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46–0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032. |
| وصف الملف: | application/pdf |
| تدمد: | 0195-668X 1522-9645 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9ddf18c65560d52cb5acaa8ded962b76Test https://www.fundanet.incliva.es/publicaciones/ProdCientif/PublicacionFrw.aspx?id=16511Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....9ddf18c65560d52cb5acaa8ded962b76 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 0195668X 15229645 |
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