用于急性和慢性冠状动脉综合征的最高生物可降解聚合物药物洗脱支架：一项PIONEER III子研究

The Supreme Biodegradable Polymer DES in Acute and Chronic Coronary Syndromes: A PIONEER III Substudy.

作者信息

Hussain Yasin, Saito Shigeru, Curtis Michael, Kereiakes Dean J, Baumbach Andreas, Zidar James P, McLaurin Brent, Dib Nabil, Smits Pieter C, Jiménez Díaz Victor Alfonso, Cequier Ángel, Hofma Sjoerd H, Pietras Cody, Dressler Ovidiu, Issever M Ozgu, Windecker Stephan, Leon Martin B, Lansky Alexandra J

机构信息

Division of Cardiology, Yale School of Medicine, New Haven, Connecticut.

Shonan Kamakura General Hospital, Kamakura, Japan.

出版信息

J Soc Cardiovasc Angiogr Interv. 2023 Mar 27;2(3):100629. doi: 10.1016/j.jscai.2023.100629. eCollection 2023 May-Jun.

BACKGROUND

The PIONEER III trial demonstrated noninferiority of 12-month target lesion failure (TLF) with the Supreme DES (Sinomed), a thin-strut cobalt-chromium, biodegradable polymer, sirolimus-eluting stent, compared with a durable polymer, everolimus-eluting (XIENCE/PROMUS) stent (DP-EES). The relative safety and effectiveness of the Supreme DES in patients with acute coronary syndromes (ACS) and those with chronic coronary syndromes (CCS) is not known.

METHODS

PIONEER III was a prospective, multicenter, international, 2:1 randomized trial stratified by clinical presentation. The primary end point was TLF at 12 months (a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization).

RESULTS

A total of 1628 patients were enrolled, including 41% of patients with ACS (unstable angina and non-ST-elevation myocardial infarction) randomized to Supreme DES (n = 441) versus DP-EES (n = 232) and 59% of patients with CCS randomized to Supreme DES (n = 645) versus DP-EES (n = 310). Patients with ACS were younger, fewer presented with less diabetes, hypertension, and previous revascularization, but more were current smokers. The primary end point of TLF (6.4% vs 4.4%; = .1), major adverse cardiac events (8.5% vs 6.5%; = .16), and stent thrombosis (0.4% vs 0.9%; = .25) at 12 months were similar in the ACS and CCS groups. There was no difference in TLF at 12 months between Supreme DES and DP-EES among patients with ACS (6.6% vs 6.0%; = .89) and those with CCS (4.5% vs 4.3%; = .83); interaction = .51 for TLF by clinical presentation.

CONCLUSIONS

Compared with the DP-EES, the Supreme DES seemed safe and effective with a similar TLF at 12 months in both patients with ACS and those with CCS.

背景

PIONEER III试验表明，与耐用聚合物依维莫司洗脱（XIENCE/PROMUS）支架（DP-EES）相比，Supreme DES（Sinomed，一种薄支柱钴铬、可生物降解聚合物、西罗莫司洗脱支架）的12个月靶病变失败（TLF）具有非劣效性。Supreme DES在急性冠状动脉综合征（ACS）患者和慢性冠状动脉综合征（CCS）患者中的相对安全性和有效性尚不清楚。

方法

PIONEER III是一项前瞻性、多中心、国际性、2:1随机试验，按临床表现分层。主要终点是12个月时的TLF（心脏死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建的复合终点）。

结果

共纳入1628例患者，其中41%为ACS患者（不稳定型心绞痛和非ST段抬高型心肌梗死），随机分为Supreme DES组（n = 441）和DP-EES组（n = 232）；59%为CCS患者，随机分为Supreme DES组（n = 645）和DP-EES组（n = 310）。ACS患者更年轻，糖尿病、高血压和既往血运重建的患者较少，但当前吸烟者较多。ACS组和CCS组12个月时的主要终点TLF（6.4%对4.4%；P = 0.1）、主要不良心脏事件（8.5%对6.5%；P = 0.16）和支架血栓形成（0.4%对0.9%；P = 0.25）相似。ACS患者（6.6%对6.0%；P = 0.89）和CCS患者（4.5%对4.3%；P = 0.83）中，Supreme DES和DP-EES在12个月时的TLF无差异；按临床表现分层的TLF交互作用P = 0.51。