Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
Lancet. 2023 Nov 25;402(10416):1979-1990. doi: 10.1016/S0140-6736(23)02197-9. Epub 2023 Oct 25.
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 ClinicalTrials.gov, NCT05484310.
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.
在接受直接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，可生物降解聚合物西罗莫司洗脱支架可改善早期支架相关临床结局。然而，在 STEMI 患者中，完全降解其聚合物涂层后，可生物降解聚合物西罗莫司洗脱支架的长期优势仍不确定。
BIOSTEMI 延长生存（BIOSTEMI ES）是一项由研究人员发起的、BIOSTEMI 前瞻性、多中心、单盲、随机优效试验的随访扩展研究，该试验比较了在瑞士 10 家医院接受直接经皮冠状动脉介入治疗的 STEMI 患者中使用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疗效。所有已签署知情同意书参与 BIOSTEMI 试验的患者均有资格参加这项随访研究。主要终点是靶病变失败，定义为 5 年内发生心脏死亡、靶血管心肌再梗死或临床指征靶病变血运重建的复合终点。如果贝叶斯后验概率小于 1 的比率（RR）小于 0.975，则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。该研究在 ClinicalTrials.gov 注册，NCT05484310。
2016 年 4 月 26 日至 2018 年 3 月 9 日，1300 例 STEMI 患者（1622 处病变）以 1:1 的比例随机分配接受可生物降解聚合物西罗莫司洗脱支架（649 例，816 处病变）或耐用聚合物依维莫司洗脱支架（651 例，806 处病变）治疗。5 年时，主要复合终点靶病变失败在接受可生物降解聚合物西罗莫司洗脱支架治疗的 50 例（8%）患者和接受耐用聚合物依维莫司洗脱支架治疗的 72 例（11%）患者中发生（差异为-3%；RR 0.70，95%贝叶斯可信区间 0.51-0.95；贝叶斯后验优势概率为 0.988）。
在接受直接经皮冠状动脉介入治疗的 STEMI 患者中，与耐用聚合物依维莫司洗脱支架相比，可生物降解聚合物西罗莫司洗脱支架在 5 年随访时可降低靶病变失败风险。这种差异是由缺血驱动的靶病变血运重建风险降低所驱动的。
百多力公司。
