Purpose: 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. Materials and Methods: 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 I2 statistic. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: 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; I2=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). Conclusion: 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.
Keywords: arteriovenous fistula; arteriovenous graft; balloon angioplasty; drug-coated balloon; drug-eluting stents; failing dialysis access; hemodialysis; mortality; paclitaxel; stenosis.
Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled TrialsK Dinh et al. J Endovasc Ther 1526602820904783. PMID 32066315.There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons o …
Clinical Effectiveness and Cost Effectiveness of Intracoronary Brachytherapy and Drug Eluting Stents [Internet]B Mørland et al. PMID 29320006. - ReviewEvidenstables with data from included studies and results of assessment are shown in attachment 4 (in English).
Paclitaxel-coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-month Interim Results From a Prospective Randomized Controlled TrialK Katsanos et al. J Endovasc Ther 19 (2), 263-72. PMID 22545894. - Randomized Controlled TrialPCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.
Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery DiseaseK Ouriel et al. JACC Cardiovasc Interv 12 (24), 2515-2524. PMID 31575518.Analyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of …
Systematic Review and Meta-analysis of Randomized Controlled Trials of Paclitaxel-Coated Balloon Angioplasty in the Femoropopliteal Arteries: Role of Paclitaxel Dose and BioavailabilityK Katsanos et al. J Endovasc Ther 23 (2), 356-70. PMID 26823485. - ReviewPCBs reduce by more than half the rates of restenosis and TLR in the femoropopliteal artery regardless of stent placement. Biologic effect size may vary according to pacl …
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Use of Paclitaxel Eluting Stents in Arteriovenous Fistulas: A Pilot StudyK Dinh et al. Vasc Specialist Int 35 (4), 225-231. PMID 31915667.This study demonstrates acceptable short-term patency for DESs in the treatment of AVF stenosis. Dual antiplatelet therapy is probably mandatory in the short term.