JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2021-03-13 , DOI: 10.1016/j.jcin.2020.12.011 Thomas Pilgrim 1 , Olivier Muller 2 , Dik Heg 3 , Marco Roffi 4 , David J Kurz 5 , Igal Moarof 6 , Daniel Weilenmann 7 , Christoph Kaiser 8 , Maxime Tapponnier 9 , Sylvain Losdat 3 , Eric Eeckhout 2 , Marco Valgimigli 1 , Peter Jüni 10 , Stephan Windecker 1 , Juan F Iglesias 4
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Objectives
The aim of this study was to investigate the safety and efficacy of biodegradable-polymer sirolimus-eluting stents (BP-SES) compared with durable-polymer everolimus-eluting stents (DP-EES) in patients with ST-segment elevation myocardial infarction (STEMI).
Background
Primary percutaneous coronary intervention (PCI) is an effective treatment for patients with STEMI, and long-term outcomes are determined by the safety and efficacy profile of the newest generation drug-eluting stents.
Methods
BIOSTEMI (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention) was an investigator-initiated, multicenter, assessor-blind, randomized superiority trial using Bayesian methods. Patients with STEMI undergoing primary PCI within 24 h of symptom onset were randomized in a 1:1 ratio to receive BP-SES (n = 649) or DP-EES (n = 651). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial reinfarction, and clinically indicated target lesion revascularization (TLR) at 2 years.
Results
Between April 2016 and March 2018, 1,300 patients were included. Baseline characteristics were comparable between the 2 treatment groups. Follow-up through 2 years was complete in 1,221 patients (94%). At 2 years, TLF occurred in 33 patients (5.1%) treated with BP-SES and in 53 patients (8.1%) treated with DP-EES (rate ratio: 0.58; 95% Bayesian credible interval: 0.40 to 0.84; posterior probability of superiority = 0.998). The difference was driven by a lower incidence of clinically indicated TLR in patients treated with BP-SES compared with DP-EES (2.5% vs. 5.1%; rate ratio: 0.52; 95% Bayesian credible interval: 0.30 to 0.87; posterior probability of superiority = 0.993). There were no significant differences in rates of cardiac death, target vessel myocardial reinfarction, and definite stent thrombosis between the 2 treatment arms.
Conclusions
In patients with STEMI undergoing primary PCI, BP-SES were superior to DP-EES with respect to TLF at 2 years. The difference was driven by lower rates of ischemia-driven TLR. (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [BIOSTEMI]; NCT02579031)
中文翻译：
用于 STEMI 的生物可降解支架与耐用聚合物药物洗脱支架
目标
本研究的目的是调查生物可降解聚合物西罗莫司洗脱支架 (BP-SES) 与耐用聚合物依维莫司洗脱支架 (DP-EES) 相比在 ST 段抬高型心肌梗死 (STEMI) 患者中的安全性和有效性。 ）。
背景
初次经皮冠状动脉介入治疗 (PCI) 是 STEMI 患者的有效治疗方法，长期结果取决于最新一代药物洗脱支架的安全性和有效性。
方法
BIOSTEMI（超薄支柱可生物降解聚合物西罗莫司洗脱支架与耐用聚合物依维莫司洗脱支架的比较，用于急性 ST 段抬高型心肌梗死接受经皮冠状动脉介入治疗的患者）使用贝叶斯方法的随机优势试验。在症状出现 24 小时内接受直接 PCI 的 STEMI 患者以 1:1 的比例随机接受 BP-SES（n = 649）或 DP-EES（n = 651）。主要终点是靶病变失败 (TLF)，这是 2 年时心源性死亡、靶血管心肌再梗死和有临床指征的靶病变血运重建 (TLR) 的复合终点。
结果
2016 年 4 月至 2018 年 3 月期间，纳入了 1,300 名患者。两个治疗组之间的基线特征具有可比性。1,221 名患者（94%）完成了为期 2 年的随访。在 2 年时，接受 BP-SES 治疗的 33 名患者 (5.1%) 和接受 DP-EES 治疗的 53 名患者 (8.1%) 发生了 TLF（比率比：0.58；95% 贝叶斯可信区间：0.40 至 0.84；后验概率为优势 = 0.998）。这种差异是由于接受 BP-SES 治疗的患者与 DP-EES 相比，临床指征 TLR 的发生率较低（2.5% 对 5.1%；比率：0.52；95% 贝叶斯可信区间：0.30 至 0.87；后验概率为优势 = 0.993）。2 个治疗组之间的心源性死亡率、靶血管心肌再梗死和明确的支架血栓形成率没有显着差异。
结论
在接受直接 PCI 的 STEMI 患者中，2 年时 BP-SES 在 TLF 方面优于 DP-EES。这种差异是由较低的缺血驱动的 TLR 率引起的。（针对急性 ST 段抬高型心肌梗塞患者接受经皮冠状动脉介入治疗 [BIOSTEMI]；NCT02579031）对超薄 Strut 可生物降解聚合物西罗莫司洗脱支架与耐用聚合物依维莫司洗脱支架的比较
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