2種洗脫支架治療ST段抬高型心肌梗死的療效比較
作者：
小柯機器人發布時間：2019/9/3 17:10:27
瑞士伯爾尼大學Stephan Windecker研究組，近日比較了生物降解聚合物西羅莫司洗脫支架與耐久聚合物依維莫司洗脫支架治療ST段抬高型心肌梗死的療效。相關論文9月1日在線發表於《柳葉刀》。
BIOSTEMI試驗是一項由研究者發起、多中心、前瞻性、單盲、隨機的優越性試驗，在瑞士的10家醫院進行。2016年4月26日至2018年3月9日，1300例18歲及以上計劃行PCI的急性ST段抬高型心肌梗死（STEMI）患者（1623處病變）按1：1隨機分配使用生物降解聚合物西羅莫司洗脫支架（649例，816處病變）或耐用聚合物依維莫司洗脫支架（651例，806處病變）進行治療。
治療12個月後，接受生物降解聚合物西羅莫司洗脫支架治療的患者中有25例（4%）發生靶病變失敗，包括心臟死亡、靶血管心肌再梗死（Q波和非Q波）和臨床顯示的靶病變血運重建，而接受耐用聚合物依維莫司洗脫支架治療的患者中有36例（6%），比率為0.59。兩組間心臟死亡、靶血管心肌再梗死、臨床顯示的靶病變血運重建和明確的支架血栓形成的發生率無顯著差異。
在初次行PCI的急性STEMI患者中，生物降解聚合物西羅莫司洗脫支架減少了缺血驅動的靶病變血運重建，1年內靶病變失敗率顯著低於耐用聚合物依維莫司洗脫支架。
據悉，與當前的細杆二代藥物洗脫支架相比，結合了超細杆金屬支架和生物降解聚合物的新一代藥物洗脫支架有助於急性心肌梗死患者行PCI後的血管癒合，並改善臨床預後。
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.