BioMime西罗莫司洗脱支架系统在所有冠状动脉狭窄患者真实世界人群中的安全性和有效性：MILES全球注册研究

Safety and Efficacy of BioMime Sirolimus-Eluting Stent System in All-Comers Real-World Population With Coronary Artery Stenosis: MILES Global Registry.

作者信息

Hudec Martin, Jeong Myung Ho, Trillo Ramiro, Ijsselmuiden Alexander J J, Gwon Hyeon-Cheol, Chae In Ho, Wang Yi-Chih, de Costa Jose Maques, Charng Min-Ji, Maskon Oteh, Burgos Jose Moreu, Mayurathan Gnanamoorthy, Mateev Hristo, Serra Antonio, Merkely Bela, Cale Rita, Hwang Shinn-Jang, Mar Guang-Yuan, Lawand Samih, Khokhlov Andriy, Montilla Beatriz Vaqueizo, Valdes Mariano, Sadeghian Mohammad

机构信息

Department of Acute Cardiology, Middle-Slovak Institute of Cardiovascular Diseases (SUSCCH), Banska Bystrica, Slovakia.

Department of Cardiology, Chonnam National University, Gwangju, Korea.

出版信息

Cardiol Res. 2024 Dec;15(6):439-452. doi: 10.14740/cr1724. Epub 2024 Dec 3.

DOI:10.14740/cr1724

PMID:39698009

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11650571/

Abstract

BACKGROUND

This study evaluated the safety and efficacy of BioMime sirolimus-eluting stent (SES) system, with an ultra-low strut thickness (65 µm), in real-world all-comers population with coronary artery stenosis (CAD).

METHODS

This was a post-marketing, multicenter, single-arm, observational clinical registry among patients undergoing intervention for CAD. Patients were clinically followed up at 1, 9, 12, and 24 months after the index percutaneous coronary intervention. Four major indications, namely long stents of > 30 mm, stents with diameters of 4 and 4.5 mm, bifurcation subgroup, and chronic total occlusion (CTO) were evaluated as pre-specified subsets.

RESULTS

A total of 771 patients (1,079 treated lesions) from 23 sites were included in this study. The mean length and diameter of the implanted stents were 25.57 ± 9.35 mm and 3.00 ± 0.44 mm, respectively. The mean minimum lumen diameter before and after the procedure was 1.00 ± 1.69 mm and 2.96 ± 1.35 mm, respectively. The cumulative rates of major adverse cardiovascular events (MACEs) and stent thrombosis (ST) at 1, 9, 12, and 24 months were 1.05%, 3.13%, 4.04%, 5.64% and 0%, 0.13%, 0.28%, 0.28%, respectively. In a subset with > 30 mm long stents, the cumulative rate of MACEs was 0.4%, 4.6%, 5.12%, and 7.01% at 1, 9, 12, and 24 months, respectively. The corresponding rates of ST were 0%, 0.42%, 0.43%, and 0.44%, indicating constant rate of ST after 9 months. In a subset of 4 and 4.5 mm diameter stents, the cumulative rate of MACEs was high (0%, 6.25%, 6.25%, and 10.41%) at 1, 9, 12, and 24 months, respectively. However, there was no case of ST until 24 months. In patients with bifurcation lesions, the cumulative rates of MACEs and ST were 2.46%, 6.32%, 11.53%, 16.21% and 0%, 1.27%, 1.28%, 1.35% at 1, 9, 12, and 24 months follow-up. In patients with chronic total occlusion, the cumulative rates of MACEs and ST were 0.79%, 5.04%, 6.83%, 7.07% and 0%, 0.84%, 0.85%, 0.88% at 1, 9, 12, and 24 months, respectively, indicating constant rate of ST after 9 months.

CONCLUSIONS

The BioMime SES demonstrated good safety and efficacy outcomes at 24-month follow-up, with low rates of MACEs and ST in patients with CAD in the real-world setting.

摘要

背景

本研究评估了具有超低支架厚度（65微米）的BioMime西罗莫司洗脱支架（SES）系统在患有冠状动脉狭窄（CAD）的真实世界所有患者群体中的安全性和有效性。

方法

这是一项针对接受CAD干预的患者进行的上市后、多中心、单臂观察性临床注册研究。在首次经皮冠状动脉介入治疗后的1、9、12和24个月对患者进行临床随访。四个主要适应症，即长度大于30毫米的长支架、直径为4毫米和4.5毫米的支架、分叉亚组以及慢性完全闭塞（CTO）被作为预先指定的亚组进行评估。

结果

本研究共纳入了来自23个地点的771例患者（1079个治疗病变）。植入支架的平均长度和直径分别为25.57±9.35毫米和3.00±0.44毫米。术前和术后的平均最小管腔直径分别为1.00±1.69毫米和2.96±1.35毫米。1、9、12和24个月时主要不良心血管事件（MACE）和支架血栓形成（ST）的累积发生率分别为1.05%、3.13%、4.04%、5.64%和0%、0.13%、0.28%、0.28%。在长度大于30毫米的长支架亚组中，1、9、12和24个月时MACE的累积发生率分别为0.4%、4.6%、5.12%和7.01%。相应的ST发生率分别为0%、0.42%、0.43%和0.44%，表明9个月后ST发生率恒定。在直径为4毫米和4.5毫米的支架亚组中，1、9、12和24个月时MACE的累积发生率分别较高（0%、6.25%、6.25%和10.41%）。然而，直到24个月时均未发生ST病例。在分叉病变患者中，随访1、9、12和24个月时MACE和ST的累积发生率分别为2.46%、6.32%、11.53%、16.21%和0%、1.27%、1.28%、1.35%。在慢性完全闭塞患者中，1、9、12和24个月时MACE和ST的累积发生率分别为0.79%、5.04%、6.83%、7.07%和0%、0.84%、0.85%、0.88%，表明9个月后ST发生率恒定。