Department of Vascular Surgery, Westmead Hospital, Westmead, New South Wales, Australia.
Department of Surgery, Westmead Hospital, Westmead, New South Wales, Australia.
J Endovasc Ther. 2019 Oct;26(5):600-612. doi: 10.1177/1526602819872154. Epub 2019 Aug 28.
To report the risk of all-cause mortality in patients who underwent dialysis access treatment using paclitaxel-coated devices compared with percutaneous transluminal angioplasty (PTA) with an uncoated balloon. A systematic review and meta-analysis of randomized controlled trials were performed to investigate the mortality outcomes associated with paclitaxel-coated devices in the treatment of patients with a failing dialysis access (last search date February 28, 2019). The primary endpoint was all-cause mortality. This analysis included 8 studies comparing paclitaxel-coated balloon (PCB) angioplasty (n=327) and PTA (n=331) in the treatment of failing dialysis access. None investigated paclitaxel-coated stents. Mortality data were pooled using a random effects model. Statistical heterogeneity was evaluated with a chi-square test and the statistic. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). At the pooled mean follow-up of 13.5 months (median 12, range 6-24) all-cause mortality was similar in the PCB group (13.8%) compared with PTA (11.2%; RR 1.26, 95% CI 0.85 to 1.89, p=0.25; =0%). Subgroup analysis, stratified according to length of follow-up, confirmed that there were no statistically significant differences in mortality at short- and midterm follow-up [6-month (8 studies): 5.2% vs 4.8%, RR 1.24, 95% CI 0.62 to 2.47, p=0.55; 12-month (6 studies): 6.3% vs 6.0%, RR 1.06, 95% CI 0.43 to 2.63, p=0.90; and 24-month (3 studies): 19.0% vs 13.5%, RR 1.38, 95% CI 0.90 to 2.12, p=0.14). The analysis found no difference in short- to midterm mortality among patients treated with a drug-coated balloon compared with PTA. With proven benefit and no evidence of harm, the authors recommend ongoing use of PCB for the failing dialysis access.
报告紫杉醇涂层设备与经皮腔内血管成形术（PTA）治疗透析通路患者的全因死亡率风险，比较未涂层球囊。系统评价和荟萃分析随机对照试验，调查紫杉醇涂层设备治疗失败透析通路（最后检索日期 2019 年 2 月 28 日）相关的死亡率结局。主要终点是全因死亡率。该分析包括 8 项比较紫杉醇涂层球囊（PCB）血管成形术（n=327）和 PTA（n=331）治疗失败透析通路的研究。均未研究紫杉醇涂层支架。使用随机效应模型汇总死亡率数据。使用卡方检验和 I ² 统计评估统计异质性。汇总统计以相对危险比（RR）表示，置信区间（CI）为 95%。在平均 13.5 个月（中位数 12 个月，范围 6-24 个月）的汇总随访中，PCB 组（13.8%）与 PTA 组（11.2%）的全因死亡率相似（RR 1.26，95%CI 0.85 至 1.89，p=0.25； I ² =0%）。根据随访时间长短进行的亚组分析证实，短期和中期随访的死亡率无统计学差异[6 个月（8 项研究）：5.2%比 4.8%，RR 1.24，95%CI 0.62 至 2.47，p=0.55；12 个月（6 项研究）：6.3%比 6.0%，RR 1.06，95%CI 0.43 至 2.63，p=0.90；24 个月（3 项研究）：19.0%比 13.5%，RR 1.38，95%CI 0.90 至 2.12，p=0.14）。分析发现，与 PTA 相比，药物涂层球囊治疗的患者短期至中期死亡率无差异。鉴于已证实的获益和无危害证据，作者建议继续使用 PCB 治疗失败的透析通路。
