瑞士日内瓦大学医院Juan F Iglesias团队研究了生物可降解聚合物西罗莫司洗脱支架在STEMI患者的聚合物涂层完全降解后的长期优势。这一研究成果于2023年10月25日发表在《柳叶刀》杂志上。

在接受初次经皮冠状动脉介入治疗的ST段抬高型心肌梗死（STEMI）患者中，与耐用聚合物依维莫司洗脱支架相比，生物可降解聚合物西罗莫司洗脱架可改善支架相关的早期临床预后。然而，可生物降解聚合物西罗莫司洗脱支架在STEMI患者的聚合物涂层完全降解后的长期优势仍不确定。

BIOSTMI延长生存期（BIOSTMI-ES）是一项由研究者发起、BIOSTMi前瞻性、多中心、单盲的随机优势试验，在瑞士十家医院对STEMI患者进行初次经皮冠状动脉介入治疗，比较了生物可降解聚合物西罗莫司洗脱支架和耐用聚合物依维莫司洗脱支架的效果。所有提供书面知情同意书参与BIOSTMI试验的个人都有资格参加这项后续研究。

主要终点是靶病变失败，定义为5年时心脏死亡、靶血管心肌再梗死或临床指示的靶病变血运重建的复合。如果比率（RR）小于1的贝叶斯后验概率大于0.975，则认为生物可降解聚合物西罗莫司洗脱支架优于耐用聚合物依维莫司洗脱架。根据意向治疗原则进行分析。

2016年4月26日至2018年3月9日，1300名STEMI患者（1622个病变）以1：1的比例被随机分配到可生物降解聚合物西罗莫司洗脱支架（649名患者，816个病变）或耐用聚合物依维莫司洗脱支架（651名患者，806个损伤）治疗。治疗5年后，50名（8%）接受生物可降解聚合物西罗莫司洗脱支架治疗的患者和72名（11%）接受耐用聚合物依维莫司洗脱架治疗的患者出现了靶病变失败的主要复合终点（差异-3%；RR 0.70，95%贝叶斯可信区间0.51-0.95；优势的贝叶斯后验概率0.988）。

研究结果表明，在接受STEMI初次经皮冠状动脉介入治疗的患者中，在5年随访时，就靶病变失败而言，生物可降解聚合物西罗莫司洗脱支架优于耐用聚合物依维莫司洗脱架。这种差异是由于缺血驱动的靶病变血运重建的风险在数值上较低。

附：英文原文

Title: Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial

Author: Juan F Iglesias, Marco Roffi, Sylvain Losdat, Olivier Muller, Sophie Degrauwe, David J Kurz, Laurent Haegeli, Daniel Weilenmann, Christoph Kaiser, Maxime Tapponnier, Stéphane Cook, Florim Cuculi, Dik Heg, Stephan Windecker, Thomas Pilgrim

Issue&Volume: 2023-10-25

Abstract:

Background

Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain.

Methods

BIOSTEMI Extended Survival (BIOSTEMI ES) was an investigator-initiated, follow-up extension study of the BIOSTEMI prospective, multicentre, single-blind, randomised superiority trial that compared biodegradable polymer sirolimus-eluting stents with durable polymer everolimus-eluting stents in patients with STEMI undergoing primary percutaneous coronary intervention at ten hospitals in Switzerland. All individuals who had provided written informed consent for participation in the BIOSTEMI trial were eligible for this follow-up study. The primary endpoint was target lesion failure, defined as a composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target lesion revascularisation, at 5 years. Superiority of biodegradable polymer sirolimus-eluting stents over durable polymer everolimus-eluting stents was declared if the Bayesian posterior probability for a rate ratio (RR) of less than 1 was greater than 0·975. Analyses were performed according to the intention-to-treat principle. The study was registered with ClinicalTrials.gov, NCT05484310.

Findings

Between April 26, 2016, and March 9, 2018, 1300 patients with STEMI (1622 lesions) were randomly allocated in a 1:1 ratio to treatment with biodegradable polymer sirolimus-eluting stents (649 patients, 816 lesions) or durable polymer everolimus-eluting stents (651 patients, 806 lesions). At 5 years, the primary composite endpoint of target lesion failure occurred in 50 (8%) patients treated with biodegradable polymer sirolimus-eluting stents and in 72 (11%) patients treated with durable polymer everolimus-eluting stents (difference of –3%; RR 0·70, 95% Bayesian credible interval 0·51–0·95; Bayesian posterior probability for superiority 0·988).

Interpretation

In patients undergoing primary percutaneous coronary intervention for STEMI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 5 years of follow-up. The difference was driven by a numerically lower risk for ischaemia-driven target lesion revascularisation.

DOI: 10.1016/S0140-6736(23)02197-9

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02197-9/abstract