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Title: Safety and efficacy of the supreme biodegradable polymer sirolimus-eluting stent in patients with diabetes mellitus
Author: Thomas, Alexander
Kereiakes, Dean J.
Baumbach, Andreas
Windecker, Stephan
Pietras, Cody
Dressler, Ovidiu
Issever, M. Ozgu
Curtis, Michael
Bertolet, Barry
Zidar, James P.
Smits, Pieter C.
Jimenez Díaz, Victor Alfonso
McLaurin, Brent
Cequier Fillat, Àngel R.
Takahashi, Akihiko
Cannon, Louis A.
Amoroso, Giovanni
Kakuta, Tsunekazu
Saito, Shigeru
Leon, Martin B.
Lansky, Alexandra J.
Keywords: Pròtesis de Stent
Artèries coronàries
Proliferació cel·lular
Stents (Surgery)
Coronary arteries
Cell proliferation
Issue Date: Apr-2022
Publisher: Society for Cardiovascular Angiography and Interventions
Abstract: 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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It is part of: Journal of the Society for Cardiovascular Angiography & Interventions, 2022, vol. 1(2)
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ISSN: 2772-9303
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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