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, Jiménez Díaz Victor Alfonso, McLaurin Brent, Cequier Ángel, Takahashi Akihiko, Cannon Louis A, Amoroso Giovanni, Kakuta Tsunekazu, Saito Shigeru, Leon Martin B, Lansky Alexandra J
Division of Cardiology, Yale School of Medicine, New Haven, Connecticut.
Christ Hospital Heart and Vascular Center, Cincinnati, Ohio.
J Soc Cardiovasc Angiogr Interv. 2022 Apr 11;1(2):100033. doi: 10.1016/j.jscai.2022.100033. eCollection 2022 Mar-Apr.
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.
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.
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, = .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, = .83). There were no significant differences in other secondary endpoints.
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.
糖尿病（DM）患者经皮冠状动脉介入治疗后的预后比非糖尿病患者更差。新型Supreme DES是一种可生物降解聚合物西罗莫司洗脱支架，旨在同步早期药物递送，限制长期炎症反应的可能性。本研究的目的是评估Supreme DES在糖尿病患者中的安全性和有效性。
这是对PIONEER III随机（2:1）对照试验中糖尿病亚组的预先指定分析，比较Supreme DES与耐用聚合物依维莫司洗脱支架（DP-EES）。主要安全性和有效性复合终点是1年时的靶病变失败，包括心源性死亡、靶血管心肌梗死或临床驱动的靶病变血运重建的复合情况。
PIONEER III试验随机纳入1629例患者，其中494例（30.3%）患有DM，331例（398个病变）随机分配至Supreme DES组，163例（208个病变）分配至DP-EES组。在糖尿病患者中，Supreme DES组1年时靶病变失败率为6.1%（20/331），DP-EES组为3.7%（6/163）（风险比=1.65；95%置信区间=0.66-4.10，P=.28）。Supreme DES组心源性死亡或靶血管心肌梗死的复合发生率为3.3%（11/331），DP-EES组为3.7%（6/163）（风险比=0.90；95%置信区间=0.33-2.44，P=.83）。其他次要终点无显著差异。
PIONEER III试验的这项预先指定的子研究表明，与市售DP-EES相比，新型Supreme DES在糖尿病患者1年时具有相对安全性和有效性。需要进行更长时间的随访以确保Supreme DES的持续安全性和有效性。
