Tang Tingni, Fang Jie, Zhang Yongbao
Becton, Dickinson and Company, Franklin Lakes, NJ.
Department of Aortic and Vascular Surgery Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
Medicine (Baltimore). 2025 Mar 21;104(12):e41949. doi: 10.1097/MD.0000000000041949.
Paclitaxel-coated balloon (PCB) and paclitaxel-eluting stent (PES) are widely used in femoropopliteal arterial disease (FPAD), while the comparison of their clinical benefit is inconclusive. This meta-analysis aimed to compare the efficacy between PCB and PES for FPAD.
Three internet databases were searched for eligible randomized controlled trials (RCTs). Random-effects model was used for pooled clinical outcomes grouped by PCB or PES, following with an indirect comparison. Subgroup analysis was planned according to age, gender, history of smoking, hypertension, and diabetes.
Twenty-five RCTs encompassing 2806 patients were included. There were no significant differences between PCB and PES concerning the incidence of primary patency rate (risk of restenosis [RR]: 0.925; 95% CI: 0.815-1.049; P = .222), target lesion revascularization (TLR) (RR: 1.248; 95% CI: 0.798-1.952; P = .332), death (RR: 1.130; 95% CI: 0.436-2.930; P = .801), restenosis (RR: 1.012; 95% CI: 0.647-1.581; P = .959), amputation (RR: 1.000; 95% CI: 0.314-3.181; P = 1.000), and thrombosis (RR: 0.240; 95% CI: 0.049-1.180; P = .079). Subgroup analysis showed a lower primary patency rate in patients ≥ 70-year-old (RR: 0.703; 95% CI: 0.510-0.968; P = .031) and an increased risk of TLR when diabetes proportion was ≥ 40.0% (RR: 1.755; 95% CI: 1.013-3.042; P = .045) with PCB. Moreover, PCB might increase mortality in smokers (RR: 1.957; 95% CI: 1.000-3.828; P = .050).
Regarding safety, no significant differences was found between PCB and PES. Further large-scale RCTs should be conducted based on the direct comparison results.
紫杉醇涂层球囊（PCB）和紫杉醇洗脱支架（PES）广泛应用于股腘动脉疾病（FPAD），但其临床获益的比较尚无定论。本荟萃分析旨在比较PCB和PES治疗FPAD的疗效。
检索三个互联网数据库以获取符合条件的随机对照试验（RCT）。采用随机效应模型对按PCB或PES分组的汇总临床结局进行分析，随后进行间接比较。计划根据年龄、性别、吸烟史、高血压和糖尿病进行亚组分析。
纳入了25项RCT，共2806例患者。PCB和PES在主要通畅率（再狭窄风险[RR]：0.925；95%可信区间[CI]：0.815 - 1.049；P = 0.222）、靶病变血管重建术（TLR）（RR：1.248；95% CI：0.798 - 1.952；P = 0.332）、死亡（RR：1.130；95% CI：0.436 - 2.930；P = 0.801）、再狭窄（RR：1.012；95% CI：0.647 - 1.581；P = 0.959）、截肢（RR：1.000；95% CI：0.314 - 3.181；P = 1.000）和血栓形成（RR：0.240；95% CI：0.049 - 1.180；P = 0.079）方面无显著差异。亚组分析显示，70岁及以上患者的主要通畅率较低（RR：0.703；95% CI：0.510 - 0.968；P = 0.031），当糖尿病比例≥40.0%时，使用PCB的患者TLR风险增加（RR：1.755；95% CI：1.013 - 3.042；P = 0.045）。此外，PCB可能会增加吸烟者的死亡率（RR：1.957；95% CI：1.000 - 3.828；P = 0.050）。
在安全性方面，PCB和PES之间未发现显著差异。应根据直接比较结果开展进一步的大规模RCT。
