Park Jong-Il, Ko Young-Guk, Lee Yong-Joon, Lee Seung-Jun, Hong Sung-Jin, Ahn Chul-Min, Kim Jung-Sun, Kim Byeong-Keuk, Hong Myeong-Ki, Yu Cheol-Woong, Rha Seung-Woon, Park Jong-Kwan, Min Pil-Ki, Yoon Chang-Hwan, Lee Sang-Rok, Park Sang-Ho, Choi Dong-Hoon
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Division of Cardiology, Korea University Anam Hospital, Seoul, South Korea.
Front Cardiovasc Med. 2022 Oct 19;9:1022071. doi: 10.3389/fcvm.2022.1022071. eCollection 2022.
The efficacy of spot stenting using drug-eluting stents (DES) for the treatment of long femoropopliteal (FP) lesion is unknown. This study aimed to compare clinical outcomes of long full coverage vs. spot coverage with DES for long FP artery disease.
This multicenter randomized trial compared long DES vs. spot DES for FP lesions longer than 150 mm. All lesions were treated with paclitaxel-eluting stents (Zilver PTX). The primary endpoint was primary patency at 12 months.
The study was terminated early after an interim analysis. A total of 103 patients (55 in the long DES group; 48 in the spot DES group) were eligible for analysis. There were no significant differences in baseline and lesion characteristics between groups. Total stent length was longer in the long DES group than in the spot DES group (225.6 ± 67.2 vs. 131.3 ± 48.7 mm, < 0.001). Technical success was achieved in all patients. There was a trend toward a higher primary patency rate at 12 months in the long DES group than in the spot DES group (87.5% vs. 67.5%, = 0.120). The rate of survival free from target lesion revascularization was significantly higher in the long DES group than in the spot DES group (91.7% vs. 72.0%, = 0.044). In multivariate Cox regression analysis, spot DES [hazard ratio (HR) 2.42, 95% confidence interval (CI) 1.14-5.12, = 0.021] and postdilation (HR 0.27, 95% CI 0.09-0.79, = 0.018) were identified as independent predictors for loss of patency at 12 months post-procedure.
Long DES were more effective than spot DES for treating long FP lesions.
Clinicaltrials.gov, identifier: NCT02701881.
使用药物洗脱支架（DES）进行点状支架置入术治疗长股腘（FP）病变的疗效尚不清楚。本研究旨在比较长段完全覆盖与点状覆盖DES治疗长段FP动脉疾病的临床结局。
这项多中心随机试验比较了长段DES与点状DES治疗长度超过150mm的FP病变。所有病变均采用紫杉醇洗脱支架（Zilver PTX）治疗。主要终点是12个月时的原发性通畅率。
中期分析后该研究提前终止。共有103例患者（长段DES组55例；点状DES组48例）符合分析条件。两组间基线和病变特征无显著差异。长段DES组的总支架长度长于点状DES组（225.6±67.2 vs. 131.3±48.7mm，P<0.001）。所有患者均取得技术成功。长段DES组12个月时的原发性通畅率有高于点状DES组的趋势（87.5% vs. 67.5%，P=0.120）。长段DES组无靶病变血运重建的生存率显著高于点状DES组（91.7% vs. 72.0%，P=0.044）。在多变量Cox回归分析中，点状DES[风险比（HR）2.42，95%置信区间（CI）1.14-5.12，P=0.021]和后扩张（HR 0.27，95%CI 0.09-0.79，P=0.018）被确定为术后12个月通畅性丧失的独立预测因素。
长段DES治疗长段FP病变比点状DES更有效。
Clinicaltrials.gov，标识符：NCT02701881。
