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基于药物涂层球囊的左主干真性分叉病变治疗

Drug-Coated Balloon-Based Treatment of Left Main True Bifurcation Lesion.

作者信息

Her Ae-Young, Kim Tae Hyun, Shin Eun-Seok, Kim Sunwon, Kim Bitna, Kim Yong Hoon, Choi Ki Hong, Cho Yun-Kyeong, Lee Hyun-Jong, Song Young Bin, Nam Chang-Wook, Gwon Hyeon-Cheol

机构信息

Division of Cardiology, Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea.

Department of Cardiology, Ulsan Medical Center, Ulsan, South Korea.

出版信息

Catheter Cardiovasc Interv. 2025 Apr;105(5):1024-1031. doi: 10.1002/ccd.31416. Epub 2025 Jan 22.

DOI:10.1002/ccd.31416
PMID:39840648
Abstract

BACKGROUND

There is a paucity of data regarding drug-coated balloon (DCB) treatment in the context of left main (LM) true bifurcation lesions.

AIMS

The aim of this study was to evaluate the safety and efficacy of DCB-based treatment for unprotected LM true bifurcation lesions.

METHODS

A total of 39 patients with LM true bifurcation lesion (Medina: 1,1,1/0,1,1/1,0,1) who were successfully treated with DCB alone or in combination with drug-eluting stent (DES) were retrospectively enrolled into the DCB-based group. They were compared with 39 propensity-matched patients who were treated with second-generation DES from the COBIS III registry (n = 2648). Major adverse cardiovascular events (MACE) were defined as cardiac death, myocardial infarction, stent or target lesion thrombosis, and target lesion revascularization at the 2-year follow-up.

RESULTS

Baseline clinical characteristics were similar between the groups, except for the prevalence of in-stent restenosis (ISR) lesions (41.0% in DCB-based group vs. 17.9% in DES-only group, p = 0.047). In the DCB-based group, 59.0% of the patients (n = 23) underwent DCB-only treatment. There were no cases of abrupt vessel closure requiring treatment following DCB application. The MACE were comparable between both groups (12.8% in DCB-based group vs. 17.9% in DES-only group, p = 0.861) after 2 years.

CONCLUSIONS

In patients with unprotected LM true bifurcation lesions, DCB-based treatment demonstrated comparable clinical outcomes at the 2-year follow-up when compared to DES-only treatment. DCB-based treatment could be considered a safe and effective alternative to DES for carefully selected patients who have achieved satisfactory predilation results (Impact of DCB Treatment in De Novo Coronary Lesion; NCT04619277).

摘要

背景

关于药物涂层球囊(DCB)治疗左主干(LM)真性分叉病变的数据较少。

目的

本研究旨在评估基于DCB的治疗方案对无保护LM真性分叉病变的安全性和有效性。

方法

回顾性纳入39例LM真性分叉病变(Medina分型:1,1,1/0,1,1/1,0,1)患者,这些患者单独使用DCB或联合药物洗脱支架(DES)成功治疗,并纳入基于DCB的治疗组。将他们与39例倾向匹配的患者进行比较,这些患者来自COBIS III注册研究(n = 2648),接受第二代DES治疗。主要不良心血管事件(MACE)定义为心脏死亡、心肌梗死、支架或靶病变血栓形成以及2年随访时的靶病变血运重建。

结果

两组间基线临床特征相似,但支架内再狭窄(ISR)病变的患病率不同(基于DCB的治疗组为41.0%,仅DES治疗组为17.9%,p = 0.047)。在基于DCB的治疗组中,59.0%的患者(n = 23)仅接受DCB治疗。应用DCB后无需要治疗的血管突然闭塞病例。2年后两组的MACE相当(基于DCB的治疗组为12.8%,仅DES治疗组为17.9%,p = 0.861)。

结论

在无保护LM真性分叉病变患者中,基于DCB的治疗在2年随访时与仅DES治疗相比显示出相当的临床结果。对于预扩张结果满意的精心挑选的患者,基于DCB的治疗可被视为DES的一种安全有效的替代方案(DCB治疗对初发冠状动脉病变的影响;NCT04619277)。

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