Treating diabetic all-comers with contemporary drug-eluting stents: Prespecified comparisons from the BIO-RESORT and the BIONYX randomized trials

Eline H. Ploumen, Rosaly A. Buiten, Marlies M. Kok, Carine J.M. Doggen, Ariel Roguin, Gillian A.J. Jessurun, Carl E. Schotborgh, Peter W. Danse, Edouard Benit, Adel Aminian, K. Gert van Houwelingen, Martin G. Stoel, Martijn Scholte, Marc Hartmann, Gerard C.M. Linssen, Paolo Zocca, Clemens von Birgelen*

*Corresponding author for this work

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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.

Original languageEnglish
JournalInternational journal of cardiology
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • Diabetes mellitus
  • Drug-eluting stents
  • Percutaneous coronary intervention
  • Randomized clinical trial

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