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. 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 , . 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). 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. Biotronik.

中文翻译：

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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治疗 ST 段抬高型心肌梗死的长期结果：BIOSTEMI 随机优势试验的 5 年随访

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支架可改善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) 患者的早期支架相关临床结果。然而，在 STEMI 患者中，可生物降解聚合物西罗莫司洗脱支架的聚合物涂层完全降解后的长期优势仍不确定。BIOSTEMI 延长生存期 (BIOSTEMI ES) 是一项由研究者发起的 BIOSTEMI 前瞻性、多中心、单盲、随机优越性试验的后续扩展研究，该试验比较了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在患有以下疾病的患者中的作用： STEMI 在瑞士的 10 家医院接受初次经皮冠状动脉介入治疗。所有提供参与 BIOSTEMI 试验书面知情同意书的个人都有资格参加这项后续研究。主要终点是 5 年时靶病变失败，定义为心源性死亡、靶血管心肌再梗死或临床指示的靶病变血运重建的综合结果。如果速率比 (RR) 小于 1 的贝叶斯后验概率大于 0·975，则可宣布可生物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支架。根据意向治疗原则进行分析。该研究已在 , 注册。2016年4月26日至2018年3月9日期间，1300名STEMI患者（1622个病变）以1:1的比例随机分配至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治疗组。洗脱支架（651 名患者，806 个病变）。5 年时，目标病变失败的主要复合终点发生在 50 名（8%）接受可生物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支架治疗的患者中（差异为 –3%） ；RR 0·70，95% 贝叶斯可信区间 0·51–0·95；贝叶斯优越性后验概率 0·988）。在因 STEMI 接受初次经皮冠状动脉介入治疗的患者中，在 5 年随访时，可生物降解聚合物西罗莫司洗脱支架在靶病灶失败方面优于耐用聚合物依维莫司洗脱支架。造成这种差异的原因是缺血驱动的靶病变血运重建的风险在数字上较低。百多力。