Jun Eun Jung, Shin Eun-Seok, Teoh Eu-Vin, Bhak Youngjune, Yuan Song Lin, Chu Chong-Mow, Garg Scot, Liew Houng Bang
Department of Cardiology, Ulsan Medical Center, Ulsan, South Korea.
Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
Front Cardiovasc Med. 2022 Apr 13;9:821380. doi: 10.3389/fcvm.2022.821380. eCollection 2022.
The safety and efficacy of drug-coated balloon (DCB) treatment for coronary chronic total occlusion (CTO) remain uncertain. The aim of this study was to evaluate the outcomes of DCB only treatment for CTO.
In this retrospective study, 101 vessels with CTO lesions dilated by balloon angioplasty with thrombolysis in myocardial infarction flow grade 3 were included. Among them, 93 vessels successfully treated with DCB only treatment were analyzed. The study endpoint was major adverse cardiac events (MACE) at 2 years, a composite of cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and target vessel thrombosis. The secondary endpoint was late lumen loss (LLL) on follow-up coronary angiography.
All 84 patients were followed up clinically, and 67 vessels underwent scheduled coronary angiography after 6 months. There were no procedural complications, and three vessels required bailout-stenting. The median follow-up was 720 days (interquartile range [IQR]; 406-1,268 days). MACE occurred in 8.3% of the patients after 1 year, including cardiac death (1.2%), TVR (7.1%), and no non-fatal MI and target vessel thrombosis. Two years after treatment, MACE occurred in 16.7% of the patients, including cardiac death (2.4%), non-fatal MI (3.6%), TVR (13.1%), and no target vessel thrombosis. The mean LLL was 0.03 ± 0.53 mm. Binary restenosis occurred in 14.9% of the treated vessels, and 3.0% of the vessels had late re-occlusion on follow-up coronary angiography.
If the result of revascularization using balloon angioplasty is good, the clinical outcomes of DCB only treatment of CTOs at the 2-year follow-up are encouraging, with a low rate of hard endpoints and acceptable MACE rates (Clinical Trial Registration Information; Impact of Drug-coated Balloon Treatment in Coronary Lesion; NCT04619277).
药物涂层球囊（DCB）治疗冠状动脉慢性完全闭塞（CTO）的安全性和有效性仍不确定。本研究的目的是评估单纯DCB治疗CTO的疗效。
在这项回顾性研究中，纳入了101例通过球囊血管成形术扩张且心肌梗死溶栓血流分级为3级的CTO病变血管。其中，对93例仅接受DCB成功治疗的血管进行了分析。研究终点为2年时的主要不良心脏事件（MACE），包括心源性死亡、非致命性心肌梗死（MI）、靶血管血运重建（TVR）和靶血管血栓形成。次要终点为随访冠状动脉造影时的晚期管腔丢失（LLL）。
所有84例患者均进行了临床随访，67例血管在6个月后接受了定期冠状动脉造影。无手术并发症，3例血管需要补救性支架置入。中位随访时间为720天（四分位间距[IQR]；406 - 1268天）。1年后，8.3%的患者发生MACE，包括心源性死亡（1.2%）、TVR（7.1%），无非致命性MI和靶血管血栓形成。治疗2年后，16.7%的患者发生MACE，包括心源性死亡（2.4%）、非致命性MI（3.6%）、TVR（13.1%），无靶血管血栓形成。平均LLL为0.03±0.53mm。14.9%的治疗血管发生了二元再狭窄，3.0%的血管在随访冠状动脉造影时出现晚期再闭塞。
如果使用球囊血管成形术进行血运重建的结果良好，单纯DCB治疗CTO在2年随访时的临床疗效令人鼓舞，硬终点发生率低，MACE率可接受（临床试验注册信息；药物涂层球囊治疗对冠状动脉病变的影响；NCT04619277）。
