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药物涂层球囊血管成形术治疗冠状动脉慢性完全闭塞的疗效:一项系统评价和荟萃分析。

Efficacy of drug-coated balloon angioplasty for coronary chronic total occlusion: A systematic review and meta-analysis.

作者信息

Gurgoglione Filippo Luca, Malakouti Sara, Khialani Bharat, Hasan Jasim, Khater Jacinthe, Occhipinti Giovanni, Donelli Davide, Cortese Bernardo

机构信息

Division of Cardiology, University of Parma, Parma University Hospital, Parma, Italy; DCB Academy, Milano, Italy.

DCB Academy, Milano, Italy.

出版信息

Cardiovasc Revasc Med. 2025 Jun;75:137-143. doi: 10.1016/j.carrev.2025.04.002. Epub 2025 Apr 10.

Abstract

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is associated with worse outcomes compared to non-CTO lesions. Whether the implantation of drug-eluting stents (DES) is the cornerstone treatment after successful recanalization of CTO, recent evidence tested the clinical performance of DCB-based PCI, alone or in concert with DES (hybrid DCB/DES approach), in this context. We aimed to conduct a comprehensive, up-to-date systematic review and summary-level meta-analysis of clinical studies comparing outcomes of DCB-based versus DEB-only angioplasty for coronary CTOs. A systematic search was performed to identify all investigations comparing DCB-based versus DES-only angioplasty for coronary CTOs. The primary endpoint was the occurrence of target vessel failure (TVF), a composite outcome of cardiac death, nonfatal myocardial infarction and target vessel revascularization. A total of 5 observational studies (2087 patients) were included in the analysis. The DCB-based PCI group experienced a trend towards a lower rate of TVF (0.45 % (112/25045) vs. 0.76 % (238/31336) person-months, IRR = 0.56 [95 % CI 0.28 to 1.10], I = 81 %, p = 0.09) and cardiac death (0.05 % vs. 0.10 % person-months, IRR = 0.55 [95 % CI 0.27 to 1.10], I = 0 %, p = 0.09), although a high extent of heterogeneity was observed. Other endpoints were not different between the two groups. In the present meta-analysis, DCB-based PCI was associated with similar outcomes compared to second-generation DES PCI for the treatment of coronary CTOs. Future randomized controlled trials will provide more robust evidence on the effectiveness of DCB in treating coronary CTOs.

摘要

与非慢性完全闭塞(CTO)病变相比,经皮冠状动脉介入治疗(PCI)慢性完全闭塞病变的预后较差。在成功再通CTO后,药物洗脱支架(DES)植入是否为基石治疗,近期有证据在此背景下测试了单纯或联合DES(混合DCB/DES方法)的基于药物涂层球囊(DCB)的PCI的临床疗效。我们旨在对比较基于DCB的血管成形术与单纯药物洗脱球囊血管成形术治疗冠状动脉CTO的临床研究进行全面、最新的系统评价和汇总水平的荟萃分析。进行了系统检索以识别所有比较基于DCB的血管成形术与单纯DES血管成形术治疗冠状动脉CTO的研究。主要终点是靶血管失败(TVF)的发生,这是一个包括心源性死亡、非致死性心肌梗死和靶血管血运重建的复合结局。分析共纳入5项观察性研究(2087例患者)。基于DCB的PCI组TVF发生率有降低趋势(0.45%(112/25045)对0.76%(238/31336)人月,IRR = 0.56 [95% CI 0.28至1.10],I² = 81%,p = 0.09)以及心源性死亡(0.05%对0.10%人月,IRR = 0.55 [95% CI 0.27至1.10],I² = 0%,p = 0.09),尽管观察到高度异质性。两组间其他终点无差异。在本荟萃分析中,基于DCB的PCI与第二代DES PCI治疗冠状动脉CTO的结局相似。未来的随机对照试验将为DCB治疗冠状动脉CTO的有效性提供更有力的证据。

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