Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial.
Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial.
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DOI：
10.1093/eurheartj/ehv500
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发表时间：
2016-01-14
影响因子：
39.3
通讯作者：
Serruys PW
中科院分区：
文献类型：
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作者：
Sabaté M;Windecker S;Iñiguez A;Okkels-Jensen L;Cequier A;Brugaletta S;Hofma SH;Räber L;Christiansen EH;Suttorp M;Pilgrim T;Anne van Es G;Sotomi Y;García-García HM;Onuma Y;Serruys PW
ST 段抬高型心肌梗死 (STEMI) 患者的特点是富含血栓的病变和大的坏死核心，这通常与动脉愈合延迟和支架相关结果受损有关。由于长期恢复天然血管腔和生理机能，生物可吸收血管支架（Absorb）的使用有可能克服这些限制。这项随机试验的目的是比较 STEMI 患者中 Absorb 和金属依维莫司洗脱支架 (EES) 的短期动脉愈合反应，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。接受初次经皮冠状动脉介入治疗的 STEMI 患者以 1:1 的比例随机分配接受 Absorb 或 EES 治疗。主要终点是 6 个月光频域成像愈合评分 (HS)，该评分基于未覆盖和/或贴壁不良的支架支柱以及管腔内填充缺陷的存在。根据学术研究联盟的定义，主要次要终点包括面向设备的复合终点 (DOCE)。 2014年1月6日至2014年9月21日期间，8个中心招募了191名患者（Absorb [n = 95]或EES [n = 96]；平均年龄58.6岁；17.8%为女性）。 6 个月时，与 EES 组相比，Absorb 组的 HS 较低 [1.74 (2.39) vs. 2.80 (4.44)；差异（90% CI）-1.06（-1.96，-0.16）； P非劣效性<0.001]。组间面向设备的复合终点也相对较低（1.1% Absorb 与 0% EES）。 Absorb 组发生 1 例明确的亚急性支架血栓形成（1.1% 与 0% EES；P = ns）。在 STEMI 情况下使用 Absorb 对罪魁祸首病灶置入支架后，动脉几乎完全愈合，6 个月时与金属 EES 的愈合效果相当。这些发现为进一步探索临床导向的结果试验提供了基础。
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.