%0 Journal Article
%T Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus.
%A Thomas A
%A Kereiakes DJ
%A Baumbach A
%A Windecker S
%A Pietras C
%A Dressler O
%A Issever MO
%A Curtis M
%A Bertolet B
%A Zidar JP
%A Smits PC
%A Jiménez Díaz VA
%A McLaurin B
%A Cequier Á
%A Takahashi A
%A Cannon LA
%A Amoroso G
%A Kakuta T
%A Saito S
%A Leon MB
%A Lansky AJ
%J J Soc Cardiovasc Angiogr Interv
%V 1
%N 2
%D 2022 Mar-Apr
%M 39132558
暂无%R 10.1016/j.jscai.2022.100033
%X <B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.