Objective

To perform an individual patient data level meta-analysis of randomised controlled trials comparing drug coated balloon angioplasty (DCB) against conventional percutaneous transluminal angioplasty (PTA) in the treatment of dysfunctional haemodialysis venous access.

Methods

A search was conducted from inception to 13 November 2020. Kaplan–Meier curves comparing DCB with PTA by target lesion primary patency (TLPP) and access circuit primary patency (ACPP) were graphically reconstructed to retrieve patient level data. One stage meta-analyses with Cox models with random effects shared frailties were conducted to determine hazard ratios (HRs). Dynamic restricted mean survival times (RMST) were conducted in view of violation of the proportional hazards assumption. Conventional two stage meta-analyses and network meta-analyses under random effects Frequentist models were conducted to determine overall and comparative outcomes of paclitaxel concentrations used. Where outliers were consistently detected through outlier and influence analyses, sensitivity analyses excluding those studies were conducted.

Results

Among 10 RCTs (1 207 patients), HRs across all models favoured DCB (one stage shared frailty HR 0.62, 95% CI 0.53 – 0.73, p < .001; two stage random effects HR 0.60, 95% CI 0.42 – 0.86, p = .018, I² = 65%) for TLPP. Evidence of time varying effects (p = .005) was found. TLPP RMST was + 3.54 months (25.0%) longer in DCB treated patients compared with PTA (p = .001) at three years. TLPP at six months, one year, and two years was 75.3% vs. 58.1%, 51.1% vs. 37.1%, and 31.4% vs. 26.0% for DCB and PTA, respectively. The P-Scores within the Frequentist network meta-analysis suggest that higher concentrations of paclitaxel were associated with better TLPP and ACPP. Among six RCTs (854 patients), the one stage model favoured DCB (shared frailty HR 0.72, 95% CI 0.60 – 0.87, p < .001) for ACPP. Conversely, the two stage random effects model demonstrated no significant difference (HR 0.76, 95% CI 0.35 – 1.67, p = .41, I² = 81%). Sensitivity analysis excluding outliers significantly favoured DCB (HR 0.61, 95% CI 0.41 – 0.91, p = .027, I² = 62%).

Conclusion

Overall evidence suggests that DCB is favoured over PTA in TLPP and ACPP.

中文翻译：

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用于功能障碍性血液透析静脉通路的药物涂层球囊：随机对照试验的患者水平 Meta 分析

客观的

对比较药物涂层球囊血管成形术 (DCB) 与传统经皮腔内血管成形术 (PTA) 治疗功能障碍血液透析静脉通路的随机对照试验进行个体患者数据级荟萃分析。

方法

从开始到 2020 年 11 月 13 日进行了搜索。通过图形重建通过目标病变初级通畅 (TLPP) 和通路初级通畅 (ACPP) 比较 DCB 与 PTA 的 Kaplan-Meier 曲线以检索患者水平数据。对具有随机效应共享弱点的 Cox 模型进行了一级荟萃分析，以确定风险比 (HR)。鉴于违反比例风险假设，进行了动态限制平均生存时间 (RMST)。进行了随机效应频率模型下的常规两阶段荟萃分析和网络荟萃分析，以确定所用紫杉醇浓度的总体和比较结果。在通过异常值和影响分析一致检测到异常值的情况下，进行了排除这些研究的敏感性分析。

结果

在 10 个 RCT（1 207 名患者）中，所有模型的 HR 都支持 DCB（一个阶段共享虚弱 HR 0.62，95% CI 0.53 – 0.73，p < .001；两阶段随机效应 HR 0.60，95% CI 0.42 – 0.86，p  = .018, I ²  = 65%) 对于 TLPP。发现了时变效应的证据 ( p  = .005)。与 PTA ( p  = .001)相比，DCB 治疗患者的 TLPP RMST 在三年时长 + 3.54 个月 (25.0%) 。六个月、一年和两年的 TLPP 分别为 75.3%对58.1%、51.1%对37.1% 和 31.4%对31.4% 。DCB 和 PTA 分别为 26.0%。频率主义网络荟萃分析中的 P 分数表明，较高浓度的紫杉醇与更好的 TLPP 和 ACPP 相关。在六项 RCT（854 名患者）中，一期模型支持 DCB（共享虚弱 HR 0.72，95% CI 0.60 – 0.87，p < .001）用于 ACPP。相反，两阶段随机效应模型显示没有显着差异（HR 0.76，95% CI 0.35 – 1.67，p  = .41，I ²  = 81%）。排除异常值的敏感性分析显着支持 DCB（HR  0.61，95 % CI 0.41 – 0.91，p = .027，I ²  = 62%）。

结论

总体证据表明，在 TLPP 和 ACPP 中，DCB 优于 PTA。