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DCA/DCB注册研究中药物涂层球囊治疗冠状动脉分叉或开口病变定向冠状动脉旋切术后的长期临床结局

Long-Term Clinical Outcomes of Drug-Coated Balloon Following Directional Coronary Atherectomy for Bifurcated or Ostial Lesions in the DCA/DCB Registry.

作者信息

Kitani Shunsuke, Igarashi Yasumi, Tsuchikane Etsuo, Nakamura Shigeru, Koshida Ryoji, Habara Maoto, Tan Michinao, Shimoji Kenichiro, Takaya Tomofumi, Kijima Mikihiro

机构信息

Department of Cardiology, Sapporo Kosei General Hospital, Hokkaido, Japan.

Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.

出版信息

Catheter Cardiovasc Interv. 2025 Feb;105(2):273-279. doi: 10.1002/ccd.31283. Epub 2024 Nov 5.

DOI:10.1002/ccd.31283
PMID:39498812
Abstract

BACKGROUND

The long-term efficacy of drug-coated balloon (DCB) angioplasty for large bifurcation lesions, particularly those involving the left main trunk (LMT), remains unclear.

AIMS

This study aimed to evaluate the long-term outcomes of directional coronary atherectomy followed by DCB (DCA/DCB) for large bifurcation lesions.

METHODS

This retrospective multicenter study analyzed 129 cases from the DCA/DCB registry, with 80.4% involving LMT bifurcation lesions. Building on previously reported 12-month outcomes, this study assessed long-term results. The primary endpoint was clinically driven (CD) target lesion revascularization (TLR) at 36 months. Secondary endpoints included CD target vessel revascularization (TVR); CD target vessel failure (TVF); and adverse events, such as all-cause mortality, cardiac death, target vessel acute myocardial infarction (AMI), and the need for coronary artery bypass grafting (CABG), at 24 and 36 months.

RESULTS

The mean follow-up was 53.4 ± 23.9 months. The CD-TLR rate was 5.0% at 24 months, and the primary endpoint was 5.9% at 36 months. CD-TVR rates were 14.0% at 24 months and 15.0% at 36 months, while CD-TVF rates were 14.9% at 24 months and 16.7% at 36 months. Adverse events included all-cause mortality rates of 0.8% at 24 months and 1.8% at 36 months, and cardiac death rates of 0.8% at both 24 and 36 months. No target vessel AMI or CABG procedures were reported.

CONCLUSION

The consistently low CD-TLR rate at 36 months supports the efficacy of the DCA/DCB strategy for large bifurcation lesions, including LMT, indicating its sustained effectiveness. These findings highlight the viability of this treatment approach.

摘要

背景

药物涂层球囊(DCB)血管成形术治疗大分叉病变,尤其是累及左主干(LMT)的病变,其长期疗效仍不明确。

目的

本研究旨在评估定向冠状动脉斑块旋切术联合DCB(DCA/DCB)治疗大分叉病变的长期疗效。

方法

这项回顾性多中心研究分析了DCA/DCB注册研究中的129例病例,其中80.4%累及LMT分叉病变。基于先前报道的12个月结局,本研究评估了长期结果。主要终点是36个月时临床驱动(CD)的靶病变血运重建(TLR)。次要终点包括CD靶血管血运重建(TVR);CD靶血管失败(TVF);以及24个月和36个月时的不良事件,如全因死亡率、心源性死亡、靶血管急性心肌梗死(AMI)以及冠状动脉旁路移植术(CABG)的需求。

结果

平均随访时间为53.4±23.9个月。24个月时CD-TLR率为5.0%,36个月时主要终点为5.9%。24个月时CD-TVR率为14.0%,36个月时为15.0%,而24个月时CD-TVF率为14.9%,36个月时为16.7%。不良事件包括24个月时全因死亡率为0.8%,36个月时为1.8%,24个月和36个月时心源性死亡率均为0.8%。未报告靶血管AMI或CABG手术。

结论

36个月时持续较低的CD-TLR率支持了DCA/DCB策略治疗包括LMT在内的大分叉病变的疗效,表明其持续有效性。这些发现凸显了这种治疗方法的可行性。

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