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A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access

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Abstract Objective The comparison between paclitaxel-coated balloon (PCB) and plain old balloon angioplasty (POBA) for hemodialysis (HD) access stenosis/occlusion has not been well investigated. The objectives of this systematic review… Click to show full abstract

Abstract Objective The comparison between paclitaxel-coated balloon (PCB) and plain old balloon angioplasty (POBA) for hemodialysis (HD) access stenosis/occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare the all-cause mortality, HD access primary patency and circuit primary patency following endovascular maintenance procedures using PCB versus POBA. Methods MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for the stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI). Results A total of 16 studies were included in this meta-analysis, 12 randomized clinical trials (RCTs) and 4 cohort studies involving 1,086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6-, 12- and 24-month post-intervention were similar between PCB and POBA groups [6-month: (OR 1.06, 95% CI 0.38, 2.96, p = .907, I2 = 19.2%); 12-month: (OR 1.20, 95% CI 0.66, 2.16, p = .554, I2=0%); 24-month: (OR 1.43, 95% CI 0.83, 2.45, p = .195, I2=0%)]. There was a significant improvement of primary patency in PCB group compared with POBA group (HR 0.47, 95% CI 0.33, 0.69, p Conclusions This systemic review and meta-analysis demonstrate that paclitaxel-coated balloon angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for hemodialysis access maintenance, with no evidence of increasing all-cause mortality based on short- and mid-term follow-ups. Further large cohort study is needed to investigate long-term mortalities.

Keywords: meta analysis; access; patency; paclitaxel coated; hemodialysis access

Journal Title: Journal of Vascular Surgery
Year Published: 2020

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