瑞士伯尔尼大学Stephan Windecker研究组，近日比较了生物降解聚合物西罗莫司洗脱支架与耐久聚合物依维莫司洗脱支架治疗ST段抬高型心肌梗死的疗效。相关论文9月1日在线发表于《柳叶刀》。
BIOSTEMI试验是一项由研究者发起、多中心、前瞻性、单盲、随机的优越性试验，在瑞士的10家医院进行。2016年4月26日至2018年3月9日，1300例18岁及以上计划行PCI的急性ST段抬高型心肌梗死（STEMI）患者（1623处病变）按1：1随机分配使用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）进行治疗。
治疗12个月后，接受生物降解聚合物西罗莫司洗脱支架治疗的患者中有25例（4%）发生靶病变失败，包括心脏死亡、靶血管心肌再梗死（Q波和非Q波）和临床显示的靶病变血运重建，而接受耐用聚合物依维莫司洗脱支架治疗的患者中有36例（6%），比率为0.59。两组间心脏死亡、靶血管心肌再梗死、临床显示的靶病变血运重建和明确的支架血栓形成的发生率无显著差异。
在初次行PCI的急性STEMI患者中，生物降解聚合物西罗莫司洗脱支架减少了缺血驱动的靶病变血运重建，1年内靶病变失败率显著低于耐用聚合物依维莫司洗脱支架。
据悉，与当前的细杆二代药物洗脱支架相比，结合了超细杆金属支架和生物降解聚合物的新一代药物洗脱支架有助于急性心肌梗死患者行PCI后的血管愈合，并改善临床预后。
附：英文原文
Title: Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial
Author: Juan F Iglesias, MD †,Prof Olivier Muller, MD †,Dik Heg, PhD,Prof Marco Roffi, MD,David J Kurz, MD,Igal Moarof, MD,Daniel Weilenmann, MD,Prof Christoph Kaiser, MD,Maxime Tapponnier, MD,Stefan Stortecky, MD,Sylvain Losdat, PhD,Eric Eeckhout, MD,Prof Marco Valgimigli, MD,Ayodele Odutayo, MD,Marcel Zwahlen, PhD,Prof Peter Jüni, MD,Prof Stephan Windecker, MD,Thomas Pilgrim, MD
Issue&Volume: September 1, 2019
Summary：
Background
Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with biodegradable polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Methods
The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bülach, Switzerland) consisted of an ultrathin strut cobalt–chromium metallic stent platform releasing sirolimus from a biodegradable polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt–chromium stent platform that releases everolimus from a durable polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov, number NCT02579031.
Findings
Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with biodegradable polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with biodegradable polymer sirolimus-eluting stents and 626 (96%) patients treated with durable polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with biodegradable polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable polymer everolimus-eluting stents (difference −1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37–0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up.
Interpretation
In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents.
LANCET：《柳叶刀》，创刊于1823年。隶属于爱思唯尔出版社，最新IF：202.731
官方网址：http://www.thelancet.com/
投稿链接：http://ees.elsevier.com/thelancet
本期文章：《柳叶刀》：Online/在线发表
