Lifecare Institute of Medical Sciences and Research, Ahmedabad, Gujarat, India.
EuroIntervention. 2013 Aug 22;9(4):493-500. doi: 10.4244/EIJV9I4A79.
We report the initial human evaluation of the novel BioMimeTM sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer for the treatment of de novo coronary lesions.
The meriT-1 trial was a prospective, non-randomised, single-arm, single-centre, first-in-human evaluation of the safety, feasibility and performance of the BioMime SES. Lesion criteria included non-occlusive stenosis ≤ 19 mm in length located in native coronary vessels. Clinical follow-up (FU) was performed at 1, 8 and 12 months; all patients were assigned for angiographic FU at eight months. A total of 30 patients (30 lesions) were enrolled between March 2009 and February 2010. Mean age was 49.9 years, 30% were diabetics, and 36.7% had previous myocardial infarction (MI). Baseline median [25%, 75% interquartile range] lesion length, reference diameter and % diameter stenosis were 15.51 mm [12.74, 20.27], 2.94 mm [2.71, 3.34], and 80.5% [67.0%, 90.7%], respectively. Overall, there was one stent implanted per lesion and procedural success was 100%. At eight-month angiographic FU (26/30), median in-stent late lumen loss was 0.15 mm [0.09, 0.33]; also, there were no cases of binary restenosis within the treated segment. Clinical FU at 12 months (100%) demonstrated absence of MACE (cardiac death, MI and target lesion revascularisation) and stent thrombosis (ST).
The novel BioMime SES demonstrated excellent performance in single coronary lesions including high procedural success and efficacy, as demonstrated by the relatively low late lumen loss (a surrogate of neointimal hyperplasia) at eight-month angiographic FU. Overall, there were no safety concerns in this preliminary evaluation including absence of MACE or ST up to 12 months.
我们报告了新型 BioMimeTM 西罗莫司洗脱支架（SES）（印度古吉拉特邦 Meril 生命科学私人有限公司）在治疗新发病变冠状动脉狭窄中的初步人体评估结果，该支架具有超薄支架平台（65μm）和可生物降解聚合物。
meriT-1 试验是一项前瞻性、非随机、单臂、单中心、首例人体评价新型 BioMime SES 的安全性、可行性和性能的研究。病变标准包括长度≤19mm 的非闭塞性狭窄，位于原生冠状动脉血管内。临床随访（FU）在 1、8 和 12 个月进行；所有患者均在 8 个月时进行血管造影 FU。2009 年 3 月至 2010 年 2 月期间共纳入 30 名患者（30 处病变）。平均年龄为 49.9 岁，30%为糖尿病患者，36.7%有心肌梗死（MI）病史。基线中位数[25%，75%四分位间距]病变长度、参考直径和%直径狭窄分别为 15.51mm[12.74, 20.27]、2.94mm[2.71, 3.34]和 80.5%[67.0%, 90.7%]。总体而言，每个病变植入 1 个支架，手术成功率为 100%。在 8 个月的血管造影 FU（26/30）中，支架内晚期管腔丢失中位数为 0.15mm[0.09, 0.33]；此外，治疗节段内无再狭窄病例。12 个月的临床 FU（100%）显示无 MACE（心源性死亡、MI 和靶病变血运重建）和支架血栓形成（ST）。
新型 BioMime SES 在单支冠状动脉病变中表现出优异的性能，包括高手术成功率和疗效，在 8 个月的血管造影 FU 中晚期管腔丢失（新生内膜增生的替代指标）相对较低。总体而言，在初步评估中未发现安全性问题，包括在 12 个月内无 MACE 或 ST。
