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

IF 1.4 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiology Research Pub Date : 2024-12-01 Epub Date: 2024-12-03 DOI:10.14740/cr1724

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

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引用次数: 0

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.

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BioMime西罗莫司洗脱支架系统在冠状动脉狭窄患者中的安全性和有效性：MILES全球注册

背景：本研究评估了超低支架厚度（65µm）的BioMime西罗莫司洗脱支架（SES）系统在现实世界中冠状动脉狭窄（CAD）患者中的安全性和有效性。方法：这是一项上市后、多中心、单组、观察性临床注册研究，研究对象是接受CAD干预治疗的患者。分别于经皮冠状动脉介入治疗后1、9、12、24个月对患者进行临床随访。四个主要适应症，即bbb30 mm长的支架，直径4和4.5 mm的支架，分叉亚组和慢性全闭塞（CTO）作为预先指定的亚群进行评估。结果：本研究共纳入23个部位的771例患者（1079例治疗病灶）。植入支架的平均长度和直径分别为25.57±9.35 mm和3.00±0.44 mm。手术前后平均最小管腔直径分别为1.00±1.69 mm和2.96±1.35 mm。1、9、12、24个月的主要不良心血管事件（mace）和支架血栓形成（ST）累积率分别为1.05%、3.13%、4.04%、5.64%和0%、0.13%、0.28%、0.28%。在bbb30 mm长的支架组中，mace的累积率分别为0.4%、4.6%、5.12%和7.01%，分别为1、9、12和24个月。相应的ST率分别为0%、0.42%、0.43%和0.44%，表明9个月后ST率不变。在直径为4 mm和4.5 mm的支架亚群中，mace的累积率分别在1、9、12和24个月时较高（0%、6.25%、6.25%和10.41%）。然而，直到24个月才出现ST病例。在分叉病变患者中，随访1、9、12、24个月mace和ST累积率分别为2.46%、6.32%、11.53%、16.21%和0%、1.27%、1.28%、1.35%。慢性全闭塞患者在1、9、12、24个月时mace和ST累积率分别为0.79%、5.04%、6.83%、7.07%和0%、0.84%、0.85%、0.88%，表明9个月后ST保持不变。结论：在24个月的随访中，BioMime SES显示出良好的安全性和有效性，在现实环境中CAD患者的mace和ST发生率较低。

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来源期刊

Cardiology Research CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

2.50

自引率

0.00%

发文量

期刊介绍： Cardiology Research is an open access, peer-reviewed, international journal. All submissions relating to basic research and clinical practice of cardiology and cardiovascular medicine are in this journal''s scope. This journal focuses on publishing original research and observations in all cardiovascular medicine aspects. Manuscript types include original article, review, case report, short communication, book review, letter to the editor.