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Selution SLR药物涂层球囊治疗ST段抬高型心肌梗死患者的临床疗效与安全性

Clinical Efficacy and Safety of Selution SLR Drug Coated Balloon in Treatment of Patients with ST Elevation Myocardial Infarction.

作者信息

Ang An Shing, Tan Damon Jie Hui, Loh Jason Kwok Kong, Ho Hee Hwa, Li Ki Fung Cliff

机构信息

Department of Cardiology, Woodlands Health.

Tan Tock Seng Hospital.

出版信息

Acta Cardiol Sin. 2025 Jul;41(4):491-500. doi: 10.6515/ACS.202507_41(4).20250428B.

Abstract

BACKGROUND

The treatment of ST-elevation myocardial infarction (STEMI) has significantly advanced with the introduction of primary percutaneous coronary intervention (PCI). While primary PCI with drug-eluting stents is widely accepted as the standard treatment, concerns regarding in-stent restenosis and stent thrombosis persist. Drug-coated balloons (DCBs) offer a promising alternative, delivering antiproliferative drugs directly to the vessel walls without leaving any metal behind.

METHODS

This clinical registry evaluated the clinical safety and efficacy of the Selution SLR DCB in 36 STEMI patients who underwent primary PCI with Selution SLR DCBs between July 2021 and April 2023 in a tertiary center in Singapore. Immediate angiographic outcomes, procedural details and 12-month clinical outcomes were analyzed.

RESULTS

The mean age of the patients was 56.6 years with male predominance (86.1%). Most patients presented with inferior STEMI (61.1%) and received Selution SLR DCBs primarily in the left circumflex artery (41.7%). No patients required bailout stenting, and most achieved significant luminal gain with < 30% residual stenosis post-PCI. At 12 months, the mortality rate was 11.1%, 5.4% of the patients required target lesion revascularization, and 5.4% had angina.

CONCLUSIONS

Our preliminary findings showed that the Selution SLR DCB was safe and effective in primary PCI with low rates of adverse events at 12 months. Further research, including randomized controlled trials, is warranted to corroborate these findings and evaluate long-term outcomes.

摘要

背景

随着直接经皮冠状动脉介入治疗(PCI)的引入,ST段抬高型心肌梗死(STEMI)的治疗取得了显著进展。虽然药物洗脱支架的直接PCI被广泛接受为标准治疗方法,但对支架内再狭窄和支架血栓形成的担忧依然存在。药物涂层球囊(DCB)提供了一种有前景的替代方案,可将抗增殖药物直接输送到血管壁,而不留下任何金属。

方法

本临床注册研究评估了2021年7月至2023年4月在新加坡一家三级中心接受Selution SLR DCB直接PCI的36例STEMI患者中Selution SLR DCB的临床安全性和有效性。分析了即时血管造影结果、手术细节和12个月的临床结果。

结果

患者的平均年龄为56.6岁,男性占主导(86.1%)。大多数患者表现为下壁STEMI(61.1%),主要在左旋支动脉接受Selution SLR DCB治疗(41.7%)。没有患者需要补救性支架置入,大多数患者在PCI后获得了显著的管腔增益,残余狭窄<30%。在12个月时,死亡率为11.1%,5.4%的患者需要进行靶病变血运重建,5.4%的患者有心绞痛。

结论

我们的初步研究结果表明,Selution SLR DCB在直接PCI中是安全有效的,12个月时不良事件发生率较低。需要进一步的研究,包括随机对照试验,以证实这些发现并评估长期结果。

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