Shin Eun-Seok, Lee Joo Myung, Her Ae-Young, Chung Ju-Hyun, Eun Lee Kyung, Garg Scot, Nam Chang-Wook, Doh Joon-Hyung, Koo Bon-Kwon
Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan.
Department of Internal Medicine, Samsung Medical Center, Division of Cardiology, Heart Vascular Stroke Institute, Sungkyunkwan University School of Medicine, Seoul.
Coron Artery Dis. 2019 Sep;30(6):425-431. doi: 10.1097/MCA.0000000000000755.
In patients with high bleeding risk, percutaneous coronary intervention is still debated. This study compared 9-month angiographic and physiologic results in patients with high bleeding risk and de novo coronary lesions treated with either paclitaxel-coated balloon (PCB) or bare-metal stent (BMS).
A total of 40 patients (40 lesions) with high bleeding risk who underwent successful balloon angioplasty with fractional flow reserve (FFR) after balloon angioplasty more than 0.80 were randomized 1: 1 to treatment with PCB versus BMS. Dual antiplatelet therapy was limited to 1 month after the procedure.
Baseline clinical and lesional characteristics were well balanced between the two groups. There was no significant difference in the postprocedural FFR (0.87 ± 0.06 in PCB vs. 0.89 ± 0.06 in BMS, P = 0.254). At 9 months, late luminal loss was significantly lower in the PCB group (0.2 ± 0.3 vs. 1.2 ± 0.8 mm, P < 0.001). Restenosis only occurred in the BMS group (0 vs. 25.0%, P = 0.049).
In patients with high bleeding risk, FFR-guided PCB treatment showed superior efficacy in terms of angiographic and physiologic patency compared with BMS at mid-term follow-up with only 1 month of dual antiplatelet therapy (Clinicaltrials.gov identifier, NCT02456402).
在出血风险高的患者中，经皮冠状动脉介入治疗仍存在争议。本研究比较了出血风险高且有新发冠状动脉病变的患者，接受紫杉醇涂层球囊（PCB）或裸金属支架（BMS）治疗后9个月的血管造影和生理学结果。
共有40例出血风险高的患者（40处病变），在球囊血管成形术后成功进行了血流储备分数（FFR）测量且FFR大于0.80，将其按1:1随机分为接受PCB治疗组和BMS治疗组。术后双联抗血小板治疗限于1个月。
两组间基线临床和病变特征均衡良好。术后FFR无显著差异（PCB组为0.87±0.06，BMS组为0.89±0.06，P = 0.254）。在9个月时，PCB组的晚期管腔丢失显著更低（0.2±0.3 vs. 1.2±0.8 mm，P < 0.001）。再狭窄仅发生在BMS组（0 vs. 25.0%，P = 0.049）。
在出血风险高的患者中，在仅1个月双联抗血小板治疗的中期随访中，FFR指导下的PCB治疗在血管造影和生理通畅性方面显示出优于BMS的疗效（Clinicaltrials.gov标识符，NCT02456402）。
