Sabaté Manel, Windecker Stephan, Iñiguez Andres, Okkels-Jensen Lisette, Cequier Angel, Brugaletta Salvatore, Hofma Sjoerd H, Räber Lorenz, Christiansen Evald Høi, Suttorp Maarten, Pilgrim Thomas, Anne van Es Gerrit, Sotomi Yohei, García-García Hector M, Onuma Yoshinobu, Serruys Patrick W
Thorax Institute, University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
Bern University Hospital, Bern, Switzerland.
Eur Heart J. 2016 Jan 14;37(3):229-40. doi: 10.1093/eurheartj/ehv500. Epub 2015 Sep 23.
Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.
ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority < 0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).
Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.
ST段抬高型心肌梗死（STEMI）患者的病变富含血栓且坏死核心较大，通常与动脉愈合延迟及支架相关预后受损有关。生物可吸收血管支架（Absorb）的应用有可能克服这些局限性，因为从长期来看它能恢复天然血管腔及生理功能。本随机试验的目的是比较STEMI患者中Absorb与金属依维莫司洗脱支架（EES）在短期内的动脉愈合反应，以此作为安全性和有效性的替代指标。
ABSORB-STEMI TROFI II是一项多中心、单盲、非劣效性随机对照试验。接受直接经皮冠状动脉介入治疗的STEMI患者被1:1随机分配接受Absorb或EES治疗。主要终点是基于未覆盖和/或贴壁不良的支架支柱及管腔内充盈缺损情况的6个月光学频域成像愈合评分（HS）。主要次要终点包括根据学术研究联盟定义的器械相关复合终点（DOCE）。在2014年1月6日至2014年9月21日期间，8个中心共纳入191例患者（Absorb组[n = 95]或EES组[n = 96]；平均年龄58.6岁；女性占17.8%）。6个月时，与EES组相比，Absorb组的HS较低[1.74（2.39）对2.80（4.44）；差异（90%CI）-1.06（-?1.96，-0.16）；非劣效性P < 0.001]。两组间器械相关复合终点也相当低（Absorb组为1.1%，EES组为0%）。Absorb组发生1例明确的亚急性支架血栓形成（1.1%对EES组的0%；P = 无统计学意义）。
在STEMI情况下使用Absorb对罪犯病变进行支架置入导致动脉几乎完全愈合，在6个月时与金属EES相当。这些发现为在临床导向的预后试验中进一步探索提供了依据。
