Horie Kazunori, Tanaka Akiko, Suzuki Kenji, Taguri Masataka, Inoue Naoto
Department of Cardiovascular Medicine, Sendai Kousei Hospital, 4-15 Hirose-cho, Aoba-ku, Sendai, Miyagi, 980-0873, Japan.
Department of Cardiology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
CVIR Endovasc. 2021 Jan 11;4(1):13. doi: 10.1186/s42155-021-00205-x.
The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB.
After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed.
The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57-16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21-12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06-0.41; p < 0.001).
At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment.
EVIDENCE-BASED MEDICINE: Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.
紫杉醇涂层球囊（PCBs）在股腘动脉支架内再狭窄（ISR）病变中的短期疗效已得到证实。本研究的目的是比较接受经皮腔内血管成形术（PTA）且使用和不使用PCB的股腘动脉ISR病变患者的5年临床结局。
在1:1倾向评分匹配后，我们从2009年至2015年在我院接受治疗的106例连续ISR患者中，提取了50例接受PTA且使用（n = 25）和不使用（n = 25）IN.PACT PCB（美敦力公司，明尼阿波利斯，明尼苏达州）的股腘动脉ISR病变患者。我们比较了PCB组和非PCB组的5年结局。主要终点是复发性再狭窄的5年累积发生率。还评估了全因死亡率、靶病变血管重建术（TLR）和非计划性大截肢。
5年时PCB治疗后的主要通畅率显著高于非PCB治疗后的通畅率（65.7%对18.7%；风险比[HR]：6.11；95%置信区间[CI]：2.57 - 16.82；p < 0.001），以及无TLR率（77.6%对53.8%；HR：3.55；95% CI：1.21 - 12.83；p = 0.020）。两组间全因死亡率和非计划性大截肢率无显著差异。Cox比例风险多变量分析显示，PCB与预防复发性再狭窄独立相关（HR：0.17；95% CI：0.06 - 0.41；p < 0.001）。
在5年时，接受PCB治疗的股腘动脉ISR病变患者的复发性再狭窄显著低于接受非PCB治疗的患者。
证据水平：2b级，非随机对照队列/随访研究。
