Kaul Upendra, Wander Gurpreet S, Mullasari Ajit, Nanjappa Manjunath C, Heggunje-Shetty Prabhakar, Alexander Thomas, Hardas Suhas, Abraham Sunita, Mathew Samuel K, Vijan Suresh, Manoj Rohit K, Chandra Udita, Thakkar Ashokkumar
Batra Hospital and Medical Research Centre, New Delhi, India.
Hero DMC Heart Institute, Dayanand Medical College and Hospital, Ludhiana, India.
AsiaIntervention. 2024 Sep 27;10(3):186-194. doi: 10.4244/AIJ-D-24-00007. eCollection 2024 Sep.
The efficacy and safety of the ultrathin BioMime sirolimus-eluting coronary stent (SES) system in treating single or multiple native coronary lesions, in-stent restenosis, and bifurcation lesions have been evidenced at 1 year.
We sought to investigate the long-term safety and efficacy of the BioMime SES in a real-world population with obstructive coronary artery disease (CAD).
The prospective, single-arm, multicentre meriT-2 trial enrolled 250 patients from 11 sites across India. The safety endpoint was the cumulative frequency of major adverse cardiovascular events (MACE) at 5 years, defined as a composite of cardiac death, myocardial infarction (MI), emergent coronary artery bypass grafting or clinically indicated target lesion revascularisation (CI-TLR). Stent thrombosis (ST) was evaluated according to the Academic Research Consortium definitions.
A total of 214 (85.6%) subjects completed the 5-year follow-up. The mean age of patients was 57.44±10.75 years, and 82.71% were males. A total of 308 lesions were treated with BioMime SES. Most of the lesions were localised in the left anterior descending artery (45.46%) and were type B2 lesions (44.81%). The cumulative MACE rate at 5 years was 8.9% (n=19), including 0.9% cardiac deaths, 1.9% MI and 6.1% CI-TLR. The rate of ST was only 0.5%. The Kaplan-Meier survivor analysis revealed actuarial survivorship of 95.6% for the intention-to-treat population (n=250) over 5 years.
The long-term clinical outcomes of the meriT-2 trial established the safety and efficacy of the ultrathin-strut biodegradable-polymer-based BioMime SES with satisfactory clinical outcomes at 5 years.
超薄生物可模拟西罗莫司洗脱冠状动脉支架（SES）系统在治疗单处或多处原发性冠状动脉病变、支架内再狭窄和分叉病变方面的有效性和安全性已在1年时得到证实。
我们试图在患有阻塞性冠状动脉疾病（CAD）的真实世界人群中研究生物可模拟SES的长期安全性和有效性。
前瞻性、单臂、多中心meriT - 2试验纳入了来自印度各地11个地点的250名患者。安全终点是5年时主要不良心血管事件（MACE）的累积发生率，定义为心脏死亡、心肌梗死（MI）、急诊冠状动脉搭桥术或临床指征的靶病变血运重建（CI - TLR）的复合终点。根据学术研究联盟的定义评估支架血栓形成（ST）。
共有214名（85.6%）受试者完成了5年随访。患者的平均年龄为57.44±10.75岁，男性占82.71%。共有308处病变接受了生物可模拟SES治疗。大多数病变位于左前降支（45.46%），且为B2型病变（44.81%）。5年时MACE的累积发生率为8.9%（n = 19），包括0.9%的心脏死亡、1.9%的MI和6.1%的CI - TLR。ST发生率仅为0.5%。Kaplan - Meier生存分析显示，意向性治疗人群（n = 250）5年的精算生存率为95.6%。
meriT - 2试验的长期临床结果证实了基于超薄支柱可生物降解聚合物的生物可模拟SES的安全性和有效性，5年时临床结果令人满意。
