Journal of the Society for Cardiovascular Angiography & Interventions (Mar 2022)

Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus

  • Alexander Thomas, MD,
  • Dean J. Kereiakes, MD,
  • Andreas Baumbach, MD,
  • Stephan Windecker, MD,
  • Cody Pietras, BA,
  • Ovidiu Dressler, MD,
  • M. Ozgu Issever, MS,
  • Michael Curtis, MD,
  • Barry Bertolet, MD,
  • James P. Zidar, MD,
  • Pieter C. Smits, MD,
  • Victor Alfonso Jiménez Díaz, MD,
  • Brent McLaurin, MD,
  • Ángel Cequier, MD,
  • Akihiko Takahashi, MD, PhD,
  • Louis A. Cannon, MD,
  • Giovanni Amoroso, MD, PhD,
  • Tsunekazu Kakuta, MD, PhD,
  • Shigeru Saito, MD,
  • Martin B. Leon, MD,
  • Alexandra J. Lansky, MD

Journal volume & issue
Vol. 1, no. 2
p. 100033

Abstract

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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.

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