Davidson Deepak, Misra Mukul, Chandra Sharad, Ramegowda Raghu Thagachagere, Chanana Bharat Bhushan, Ray Shuvanan, Parikh Keyur, Roy Sanjeeb, Jain Rajendra Kumar, Rathnavel Sivakumar, Thomson Viji Samuel, Subramanian Rajalekshmi, Narasimha Kapardhi Pannala Lakshmi, Manohar Ganesan, Thachathodiyl Rajesh, Varma Raja Sekhar, Chopra Arun Kumar, Hiremath Jagdish S, Chopada Manojkumar Bhavarilal, Thakkar Ashokkumar
Caritas Hospital, Kottayam, India.
Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, India.
AsiaIntervention. 2025 Mar 20;11(1):14-25. doi: 10.4244/AIJ-D-24-00008. eCollection 2025 Mar.
Long stents reduce the risk for in-stent restenosis associated with percutaneous coronary interventions in long, tapered coronary lesions.
The Morph India study investigated the long-term safety and clinical performance of the BioMime Morph sirolimus-eluting stent (SES), a tapered stent used for treating long coronary lesions.
This is a prospective, multicentre, single-arm, real-world, post-marketing surveillance study conducted among patients with long coronary lesions (length >26 mm to ≤56 mm, reference vessel diameter 2.25-3.50 mm) implanted with the BioMime Morph SES. The primary endpoint was freedom from target lesion failure (TLF). The incidence of target vessel failure (TVF) - defined as a composite of cardiac death related to the target vessel, target vessel myocardial infarction (TVMI), and ischaemia-driven target vessel revascularisation (ID-TVR) - was the secondary endpoint. An angiographic follow-up was conducted at 9 months, and subjects were followed up for 3 years.
Out of 448 enrolled patients, 420 patients completed the 3-year follow-up. The rate of freedom from TLF was 99.31% at 12 months and 98.80% at 3 years. In 3 years, there were 4 events each of TVMI, TVR (including ID-TVR) and ischaemia-driven target lesion revascularisation (all 0.95%). Quantitative coronary angiography analysis at a mean of 9.2 months revealed in-segment late lumen loss (LLL) of 0.29±0.23 mm and in-device LLL of 0.35±0.11 mm. The in-device minimal lumen diameter improved from 0.63±0.42 mm at preprocedure to 2.13±0.37 mm (p<0.001) at 9.2 months.
The 3-year safety and clinical outcomes of BioMime Morph SES for treating long coronary lesions were satisfactory. Further long-term comparative studies are necessary to validate these results.
在长节段、逐渐变细的冠状动脉病变的经皮冠状动脉介入治疗中，长支架可降低支架内再狭窄风险。
Morph India研究调查了用于治疗长冠状动脉病变的锥形生物可吸收依维莫司洗脱支架（SES）的长期安全性和临床性能。
这是一项前瞻性、多中心、单臂、真实世界、上市后监测研究，研究对象为植入生物可吸收依维莫司洗脱支架的长冠状动脉病变（长度>26 mm至≤56 mm，参考血管直径2.25 - 3.50 mm）患者。主要终点为无靶病变失败（TLF）。靶血管失败（TVF）的发生率（定义为与靶血管相关的心脏死亡、靶血管心肌梗死（TVMI）和缺血驱动的靶血管血运重建（ID-TVR）的复合事件）为次要终点。在9个月时进行血管造影随访，并对受试者进行3年随访。
在448例入组患者中，420例患者完成了3年随访。12个月时无TLF的发生率为99.31%，3年时为98.80%。3年中，TVMI、TVR（包括ID-TVR）和缺血驱动的靶病变血运重建各有4例事件（均为0.95%）。平均9.2个月时的定量冠状动脉造影分析显示，节段内晚期管腔丢失（LLL）为0.29±0.23 mm，支架内LLL为0.35±0.11 mm。支架内最小管腔直径从术前的0.63±0.42 mm改善至9.2个月时的2.13±0.37 mm（p<0.001）。
生物可吸收依维莫司洗脱支架治疗长冠状动脉病变的3年安全性和临床结局令人满意。需要进一步的长期比较研究来验证这些结果。
