Patted Suresh V, Jain Rajendra Kumar, Jiwani P A, Suryavanshi Satish, Raghu T R, Raveesh Hema, Rajalakshmi S, Thakkar Ashok S, Turiya Prakash Kumar, Desai Priyanka J, Patted Anmol Suresh, Sharma Kamal H
KLE Academy of Higher Education and Research Centre (KLE University), Belgaum, Karnataka, 590010, India.
KIMS Hospital, Hyderabad, Telangana, 500003, India.
Cardiol Res. 2018 Dec;9(6):350-357. doi: 10.14740/cr795. Epub 2018 Dec 7.
When coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world's first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused coronary lesions in real world scenario.
This was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up.
Out of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient.
The present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered coronary lesions in routine clinical practice.
当冠状动脉病变累及长度超过48毫米的节段时,唯一的治疗选择是支架重叠,这会导致更高的新生内膜增生,进而引发更多的再狭窄。此外,冠状动脉的逐渐变细是长节段弥漫性冠状动脉病变面临的一项重大挑战。本研究旨在评估全球首个商业化的长锥形(60毫米)西罗莫司洗脱冠状动脉支架(SES)系统在现实世界场景中治疗长节段弥漫性冠状动脉病变的安全性和性能。
这是一项回顾性、非随机、多中心研究,纳入了362例连续接受长锥形BioMime™ Morph SES系统植入以治疗长节段弥漫性冠状动脉病变的患者。安全性终点为12个月随访时的主要不良心脏事件(MACE),其定义为心源性死亡、心肌梗死(MI)和缺血驱动的靶病变血运重建(ID-TLR)的复合事件。
在纳入的362例患者中,170例(47.0%)为糖尿病患者,159例(43.9%)为高血压患者。所有患者的平均年龄为61.09±9.04岁。共识别出625处病变;其中402处病变成功使用BioMime Morph进行了干预。12个月随访时MACE的累积发生率为7例(2.0%),包括4例(1.1%)心源性死亡、1例(0.3%)MI和2例(0.6%)ID-TLR。1例(0.3%)患者报告发生急性支架血栓形成。
本研究证实了BioMime Morph的安全性和性能,因此,在常规临床实践中可被视为长节段弥漫性锥形冠状动脉病变的首选治疗方法。