دورية أكاديمية
Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus
| العنوان: | Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus |
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| المؤلفون: | Thomas, A, Kereiakes, DJ, Baumbach, A, Windecker, S, Pietras, C, Dressler, O, Issever, MO, Curtis, M, Bertolet, B, Zidar, JP, Smits, PC, Jiménez Díaz, VA, McLaurin, B, Cequier, Á, Takahashi, A, Cannon, LA, Amoroso, G, Kakuta, T, Saito, S, Leon, MB, Lansky, AJ |
| سنة النشر: | 2022 |
| المجموعة: | Queen Mary University of London: Queen Mary Research Online (QMRO) |
| الوصف: | Background: Patients with diabetes mellitus (DM) have worse outcomes following percutaneous coronary intervention than nondiabetic patients. The novel Supreme DES is a biodegradable polymer sirolimus-eluting stent designed to synchronize early drug delivery, limiting the potential for long-term inflammatory response. The purpose of this study was to evaluate the safety and efficacy of the Supreme DES in patients with DM. Methods: This is a prespecified analysis of the diabetic subgroup from the PIONEER III randomized (2:1), controlled trial, comparing the Supreme DES with a durable polymer everolimus-eluting stent (DP-EES). The primary safety and efficacy composite endpoint was target lesion failure at 1 year, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Results: The PIONEER III trial randomized 1629 patients, of which 494 (30.3%) had DM with 331 (398 lesions) randomly assigned to Supreme DES and 163 (208 lesions) to DP-EES. Among patients with DM, target lesion failure at 1 year was 6.1% (20/331) with Supreme DES vs 3.7% (6/163) with DP-EES (hazard ratio = 1.65; 95% confidence interval = 0.66-4.10, P =.28). The composite of cardiac death or target vessel myocardial infarction was 3.3% (11/331) with Supreme DES and 3.7% (6/163) with DP-EES (hazard ratio = 0.90; 95% confidence interval = 0.33-2.44, P =.83). There were no significant differences in other secondary endpoints. Conclusions: This prespecified substudy of the PIONEER III trial demonstrated the relative safety and efficacy of the novel Supreme DES when compared with commercially available DP-EES in diabetics at 1 year. Longer term follow-up will be required to ensure continued safety and efficacy of the Supreme DES. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| العلاقة: | Journal of the Society for Cardiovascular Angiography and Interventions; https://qmro.qmul.ac.uk/xmlui/handle/123456789/89022Test |
| DOI: | 10.1016/j.jscai.2022.100033 |
| الإتاحة: | https://doi.org/10.1016/j.jscai.2022.100033Test https://qmro.qmul.ac.uk/xmlui/handle/123456789/89022Test |
| حقوق: | Attribution 3.0 United States ; http://creativecommons.org/licenses/by/3.0/usTest/ |
| رقم الانضمام: | edsbas.249B8E4A |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.jscai.2022.100033 |
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