Lee Sang Yeub, Cho Yun-Kyeong, Kim Sang-Wook, Hong Young-Joon, Koo Bon-Kwon, Bae Jang-Whan, Lee Seung-Hwan, Yang Tae Hyun, Park Hun Sik, Choi Si Wan, Lim Do-Sun, Kim Soo-Joong, Jeong Young Hoon, Lee Hyun-Jong, Lee Kwan Yong, Shin Eun-Seok, Kim Ung, Kim Moo Hyun, Nam Chang-Wook, Hur Seung-Ho, Kim Doo-Il
Division of Cardiology, Chung-Ang University Gwangmyeong Hospital and Department of Internal Medicine, Chung-Ang University College of Medicine, Gwangmyeong, Korea.
Department of Cardiology, Keimyung University Dongsan Hospital, Daegu, Korea.
Korean Circ J. 2022 Jun;52(6):444-454. doi: 10.4070/kcj.2021.0261. Epub 2022 Mar 15.
The aim of this study was to demonstrate the efficacy and safety of treatment with drug-coated balloon (DCB) in a large real-world population.
Patients treated with DCBs were included in a multicenter observational registry that enrolled patients from 18 hospitals in Korea between January 2009 and December 2017. The primary outcome was target lesion failure (TLF) defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically indicated target lesion revascularization at 12 months.
The study included 2,509 patients with 2,666 DCB-treated coronary artery lesions (1,688 [63.3%] with in-stent restenosis [ISR] lesions vs. 978 [36.7%] with de novo lesions). The mean age with standard deviation was 65.7±11.3 years; 65.7% of the patients were men. At 12 months, the primary outcome, TLF, occurred in 179 (6.7%), 151 (8.9%), 28 (2.9%) patients among the total, ISR, and de novo lesion populations, respectively. A history of hypertension, diabetes, acute coronary syndrome, previous coronary artery bypass graft, reduced left ventricular ejection fraction, B2C lesion and ISR lesion were independent predictors of 12 months TLF in the overall study population.
This large multicenter DCB registry study revealed the favorable clinical outcome of DCB treatment in real-world practice in patient with ISR lesion as well as small de novo coronary lesion.
本研究旨在证明药物涂层球囊（DCB）治疗在大量真实世界人群中的有效性和安全性。
接受DCB治疗的患者被纳入一个多中心观察性登记研究，该研究纳入了2009年1月至2017年12月期间韩国18家医院的患者。主要结局是靶病变失败（TLF），定义为12个月时心血管死亡、靶血管心肌梗死和临床指征的靶病变血运重建的复合终点。
该研究纳入了2509例患者，共2666处接受DCB治疗的冠状动脉病变（1688处[63.3%]为支架内再狭窄[ISR]病变，978处[36.7%]为原发病变）。平均年龄及标准差为65.7±11.3岁；6（此处原文有误，应为65.7%）5.7%的患者为男性。在12个月时，主要结局TLF分别在总体、ISR和原发病变人群中的179例（6.7%）、151例（8.9%）、28例（2.9%）患者中发生。高血压病史、糖尿病、急性冠状动脉综合征、既往冠状动脉旁路移植术、左心室射血分数降低、B2C病变和ISR病变是整个研究人群中12个月TLF的独立预测因素。
这项大型多中心DCB登记研究揭示了DCB治疗在真实世界中对ISR病变患者以及小的原发冠状动脉病变患者的良好临床结局。
