1. Treating diabetic all-comers with contemporary drug-eluting stents: Prespecified comparisons from the BIO-RESORT and the BIONYX randomized trials.
- Author
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Ploumen EH, Buiten RA, Kok MM, Doggen CJM, Roguin A, Jessurun GAJ, Schotborgh CE, Danse PW, Benit E, Aminian A, van Houwelingen KG, Stoel MG, Scholte M, Hartmann M, Linssen GCM, Zocca P, and von Birgelen C
- Subjects
- Biodegradable Plastics, Humans, Multicenter Studies as Topic, Prosthesis Design, Randomized Controlled Trials as Topic, Research Design, Sirolimus administration & dosage, Diabetes Mellitus drug therapy, Drug-Eluting Stents, Everolimus administration & dosage, Sirolimus analogs & derivatives
- Abstract
Background: Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES)., Methods: We performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic., Results: In BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44-1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44-1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52-1.48]; p = 0.63)., Conclusions: There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes., Competing Interests: Declaration of Competing Interest CvB reports that the research department of Thoraxcentrum Twente has received research grants provided by Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. All other authors declared that they have no conflict of interest., (Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2021
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