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 , number .

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.

Funding

Biotronik.

中文翻译：

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ST段抬高型心肌梗死（BIOSTEMI）患者的生物可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：一项单盲，前瞻性，随机性试验

背景

与当代的薄支撑第二代药物洗脱支架相比，将超薄支撑金属平台与可生物降解的聚合物相结合的新一代药物洗脱支架可能有助于血管性愈合并改善接受原发性经皮冠状动脉介入治疗（PCI）的急性心肌梗死患者的临床疗效。我们进行了一项随机临床试验，以研究超薄支杆可生物降解聚合物西罗莫司洗脱支架与薄支杆耐用聚合物依维莫司洗脱支架在接受原发性PCI的急性ST段抬高型心肌梗死（STEMI）患者中的安全性和有效性。

方法

BIOSTEMI试验是在瑞士的十家医院进行的，由研究人员发起的，多中心，前瞻性，单盲，随机对照试验。接受原发性PCI治疗的18岁以上急性STEMI患者有资格参加。患者被随机分配（1：1）使用可生物降解的聚合物西罗莫司洗脱支架或耐用的聚合物依维莫司洗脱支架。根据计算机生成的分配序列（具有2、4和6的可变块大小）进行中央随机分配，并按中心，糖尿病状况以及是否存在多支冠状动脉疾病进行分层，并使用安全的网络隐藏基于系统。患者和主治医师了解小组分配情况，而结果评估者则被掩盖在分配的支架上。实验性支架（Orsiro；Biotronik; 瑞士比拉赫（Bülach，Switzerland）由超薄撑杆钴铬金属支架平台组成，该平台从可生物降解的聚合物中释放西罗莫司。对照支架（Xience Xpedition / Alpine；美国伊利诺伊州阿伯特帕克的Abbott Vascular公司）由一个薄的钴钴铬合金支架平台组成，该平台可从一种耐用的聚合物中释放依维莫司。主要终点为指标手术后12个月内的目标病变衰竭，心源性死亡，目标血管心肌再梗死（Q波和非Q波）以及临床指示的目标病变血运重建的综合结果。所有分析均以参加者为分析单位，并按照意向治疗原则进行。审判的登记号码是。瑞士）由超薄支撑钴铬金属支架平台组成，可从可生物降解的聚合物中释放西罗莫司。对照支架（Xience Xpedition / Alpine；美国伊利诺伊州阿伯特帕克的Abbott Vascular公司）由一个薄的钴钴铬合金支架平台组成，该平台可从一种耐用的聚合物中释放依维莫司。主要终点为指标手术后12个月内的目标病变衰竭，心源性死亡，目标血管心肌再梗死（Q波和非Q波）以及临床指示的目标病变血运重建的综合结果。所有分析均以参加者为分析单位，并按照意向治疗原则进行。审判的登记号码是。瑞士）由超薄支撑钴铬金属支架平台组成，可从可生物降解的聚合物中释放西罗莫司。对照支架（Xience Xpedition / Alpine；美国伊利诺伊州阿伯特帕克的Abbott Vascular公司）由一个薄的钴钴铬合金支架平台组成，该平台可从一种耐用的聚合物中释放依维莫司。主要终点为指标手术后12个月内的目标病变衰竭，心源性死亡，目标血管心肌再梗死（Q波和非Q波）以及临床指示的目标病变血运重建的综合结果。所有分析均以参加者为分析单位，并按照意向治疗原则进行。审判的登记号码是。美国）由一个薄的钴钴铬支架平台组成，该平台可从一种耐用的聚合物中释放出依维莫司。主要终点为指标手术后12个月内的目标病变衰竭，心源性死亡，目标血管心肌再梗死（Q波和非Q波）以及临床指示的目标病变血运重建的综合结果。所有分析均以参加者为分析单位，并按照意向治疗原则进行。审判的登记号码是。美国）由一个薄的钴钴铬支架平台组成，该平台可从一种耐用的聚合物中释放出依维莫司。主要终点为指标手术后12个月内的目标病变衰竭，心源性死亡，目标血管心肌再梗死（Q波和非Q波）以及临床指示的目标病变血运重建的综合结果。所有分析均以参加者为分析单位，并按照意向治疗原则进行。审判的登记号码是。在索引程序的12个月内。所有分析均以参加者为分析单位，并按照意向治疗原则进行。审判的登记号码是。在索引程序的12个月内。所有分析均以参加者为分析单位，并按照意向治疗原则进行。审判的登记号码是。

发现

在2016年4月26日至2018年3月9日之间，我们随机分配了1300例急性心肌梗死患者（1623个病灶），以可生物降解的聚合物西罗莫司洗脱支架（649例患者和816个病灶）或耐用的聚合物依维莫司洗脱支架（651患者和806个病变）。在12个月时，有614例（95％）使用可生物降解的聚合物西罗莫司洗脱支架治疗的患者和626例（96％）使用耐用的聚合物依维莫司洗脱支架治疗的患者有随访数据。目标损伤失败的主要复合终点发生在使用可生物降解的聚合物西罗莫司洗脱支架治疗的649例患者中的25（4％）和使用耐久的聚合物依维莫司洗脱支架治疗的651例患者中有36（6％）（差异-1·6％点；比率为0·59，95％贝叶斯可信区间为0·37-0·94；优势的后验概率0·986）。在随访的12个月中，两个治疗组之间的心源性死亡，靶血管心肌再梗死，临床指示的靶病变血运重建和明确的支架血栓形成相似。

解释

对于急性STEMI患者，接受原发性PCI时，可生物降解的聚合物西罗莫司洗脱支架在1年时的目标病变失败方面优于耐用的聚合物依维莫司洗脱支架。与使用持久性聚合物依维莫司洗脱支架相比，使用可生物降解的聚合物西罗莫司洗脱支架治疗的患者局部缺血引起的靶病变血运重建减少是造成这种差异的原因。

资金

Biotronik。