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药物涂层球囊与非涂层球囊用于分叉病变分支治疗的系统评价和Meta分析

Drug-Coated Balloons Versus Non-Coated Balloons for Side Branch Treatment in Bifurcation Lesions: A Systematic Review and Meta-Analysis.

作者信息

Rocchetti Matteo, Tua Lorenzo, Cereda Alberto, Conconi Barbara, Gabriele Franchina A, Carlà Matteo, Spangaro Andrea, Lucreziotti Stefano

机构信息

Division of Cardiology, Cardio-Thoracic Department, San Carlo Borromeo Hospital (ASST Santi Paolo e Carlo), Milan, Italy.

University of Milan, Milan, Italy.

出版信息

Catheter Cardiovasc Interv. 2025 Jul;106(1):530-539. doi: 10.1002/ccd.31571. Epub 2025 May 9.

Abstract

BACKGROUND

Coronary bifurcation lesions (CBL) account for ~20% of percutaneous coronary interventions (PCI). When using provisional stenting, optimal management of a diseased side branch (SB) remains debated. Drug-coated balloons (DCBs) are an emerging option, but data on their role in CBL PCI are limited.

AIMS

We conducted a meta-analysis to compare DCBs and non-compliant balloons (NCBs) for SB treatment.

METHODS

A systematic search of MEDLINE, CENTRAL, and EmBase (until November 2024) identified studies comparing DCBs and NCBs for treating the SB. From 1451 studies, five were included (two randomized controlled trials [RCTs], three observational), with 1762 patients, predominantly male with acute coronary syndrome (ACS). The primary outcome was major adverse cardiac events (MACE); secondary outcomes included myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR).

RESULTS

DCBs significantly reduced MACE (pooled OR 0.48, 95% CI 0.34-0.68, p < 0.0001, I² = 0%) and MI (pooled OR 0.39, 95% CI 0.25-0.62, p < 0.001, I² = 0%) compared to NCBs. No significant differences were observed in TLR or TVR. Subgroup analysis confirmed consistency across observational studies and RCTs for MACE and MI.

CONCLUSIONS

DCBs in SB treatment during CBL PCI are associated with reduced MACE and MI compared to NCBs, with no significant differences in vessel-specific outcomes. These findings suggest a potential clinical benefit of DCBs in reducing ischemic events, while limiting stenting in CBL. Further research is needed to refine patient selection and optimize outcomes.

摘要

背景

冠状动脉分叉病变(CBL)约占经皮冠状动脉介入治疗(PCI)的20%。在使用临时支架置入术时,病变分支(SB)的最佳处理方法仍存在争议。药物涂层球囊(DCB)是一种新兴的选择,但关于其在CBL PCI中作用的数据有限。

目的

我们进行了一项荟萃分析,比较DCB和非顺应性球囊(NCB)用于SB治疗的效果。

方法

系统检索MEDLINE、CENTRAL和EmBase(截至2024年11月),以确定比较DCB和NCB治疗SB的研究。从1451项研究中,纳入了5项(2项随机对照试验[RCT],3项观察性研究),共1762例患者,主要为患有急性冠状动脉综合征(ACS)的男性。主要结局是主要不良心脏事件(MACE);次要结局包括心肌梗死(MI)、靶病变血运重建(TLR)和靶血管血运重建(TVR)。

结果

与NCB相比,DCB显著降低了MACE(合并OR 0.48,95%CI 0.34 - 0.68,p < 0.0001,I² = 0%)和MI(合并OR 0.39,95%CI 0.25 - 0.62,p < 0.001,I² = 0%)。在TLR或TVR方面未观察到显著差异。亚组分析证实了观察性研究和RCT在MACE和MI方面结果的一致性。

结论

与NCB相比,CBL PCI期间使用DCB治疗SB与降低MACE和MI相关,在血管特异性结局方面无显著差异。这些发现表明DCB在减少缺血事件方面具有潜在临床益处,同时限制了CBL中的支架置入。需要进一步研究以优化患者选择并改善结局。

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