紫杉醇涂层球囊治疗股腘动脉支架内再狭窄与术后患者死亡的关系:Meta分析

目的采用Meta分析评价紫杉醇涂层球囊治疗股腘动脉支架内再狭窄(ISR)与术后患者死亡的关系。方法检索PubMed、Cochrane、EMbase、中国知网、维普数据库、万方医学网中自建库至2021年9月1日关于紫杉醇涂层球囊治疗股腘动脉ISR的随机对照试验,根据纳入和排除标准筛选文献。以RevMan 5.3软件进行Meta分析。结果共纳入4项研究、351例股腘动脉ISR患者;其中试验组(n=183)均接受紫杉醇涂层药物球囊、对照组(n=168)均接受普通球囊干预;术后随访0.5~26.0个月,平均(18.5±7.6)个月。异质性分析显示文献间无明显异质性,故采用固定效应模型进行分析。试验组总死亡率为4.92%(9/183),对照组为4.76%(8/168),差异无统计学意义,风险比(RR)为1.0295%CI(0.41,2.52),P=0.96]。术后6个月内、6~12个月及12~24个月,试验组死亡率分别为2.90%(4/138)、2.33%(3/129)及2.70%(2/74),对照组分别为3.28%(4/122)、3.39%(4/118)及0(0/69),组间各时间段死亡率差异均无统计学意义,RR分别为0.8895%CI(0.27,2.94),P=0.84]、0.7195%CI(0.16,3.06),P=0.64]及4.7395%CI(0.24,95.09),P=0.31]。结论紫杉醇涂层球囊治疗股腘动脉ISR与术后患者死亡未见明显关联。

Correlation of treatment of in-stent restenosis of femoropopliteal artery via paclitaxel-coated balloon catheters and patient death after interventions: Meta-analysis

Objective To explore the correlation of paclitaxel-coated balloon-directed treatment for in-stent restenosis (ISR) and patient death after intervention with meta-analysis. Methods The randomized controlled trials of paclitaxel-coated balloon for treatment of femoral popliteal artery ISR were searched in PubMed, Cochrane, EMbase, CNKI, VIP database and Wanfang Med Online from the time of establishment to September 1, 2021, and the literature were screened according to the inclusion and exclusion criteria. Meta-analysis were performed using RevMan 5.3 software. Results Totally 4 studies were enrolled, including 351 patients with femoral-popliteal artery ISR. Paclitaxel-coated balloon intervention was applied in the study group (n=183), and common balloon intervention was applied in the control group (n=168). The following-up periods were 0.5 to 26.0 months, with an average of (18.5±7.6) months. Heterogeneity analysis results showed that there was no heterogeneity among 4 studies, so the fixed-effect model was used for analysis. The total mortality was 4.92% (9/183) in study group and 4.76% (8/168) in control group, which was not significant different, and the risk ratio (RR) was 1.02 (95%CI 0.41, 2.52], P=0.96). Within 6 months, 6 to 12 months and 12 to 24 months after intervention, the mortality rate was 2.90% (4/138), 2.33% (3/129) and 2.70% (2/74) in the study group, 3.28% (4/122), 3.39% (4/118) and 0 (0/69) in the control group, respectively. There was no significant difference of mortality between groups at all time periods. RR was 0.88 (95%CI 0.27, 2.94], P=0.84), 0.71 (95%CI 0.16, 3.06], P=0.64) and 4.73 (95%CI0.24, 95.09], P=0.31), respectively. Conclusion Paclitaxel-coated balloon for ISR of femoral-popliteal artery had no significant correlation with patients death after interventions.