Advertisement

August 27, 2019

Meta-Analysis Evaluates Mortality After Paclitaxel-Coated Device Use in Dialysis Access

August 28, 2019—Krystal Dinh, BMed, et al, published findings from an investigation of 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. The study is available online ahead of print in Journal of Endovascular Therapy (JEVT).

The investigators performed a systematic review and meta-analysis of randomized controlled trials (last search date of the review, February 28, 2019) to assess the mortality outcomes associated with paclitaxel-coated devices in the treatment of patients with a failing dialysis access. The primary endpoint was all-cause mortality.

As summarized in JEVT, this analysis included eight studies comparing paclitaxel-coated balloon (PCB) angioplasty (n = 327) and PTA (n = 331) in the treatment of failing dialysis access. No studies 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.

At the pooled mean follow-up of 13.5 months (median, 12 months; range, 6–24 months), all-cause mortality was similar in the PCB group and the PTA group (13.8% vs 11.2%; relative risk [RR], 1.26; 95% confidence interval [CI], 0.85–1.89; P = .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 (eight studies): 5.2% vs 4.8%; RR, 1.24; 95% CI, 0.62–2.47; P = .55
  • 12-month (six studies): 6.3% vs 6%; RR, 1.06; 95% CI, 0.43–2.63; P = .9
  • 24-month (three studies): 19% vs 13.5%; RR, 1.38; 95% CI, 0.9–2.12; P = .14

The analysis found no difference in short- to midterm mortality among patients treated with a PCB compared with PTA. With proven benefit and no evidence of harm, the ongoing use of PCBs for the failing dialysis access is recommended, concluded the investigators in JEVT.

Professor Ramon L. Varcoe, MBBS, the study's senior investigator, discussed the implications of the findings with Endovascular Today. He is Associate Professor of Vascular Surgery at Prince of Wales Private Hospital in Randwick, New South Wales, Australia.

Prof. Varcoe commented to Endovascular Today, "With a safety signal observed for claudicants receiving treatment with paclitaxel-coated devices, we felt it was important to explore this in the group of patients with end-stage renal disease receiving treatment for the failing dialysis access. This is a very different group of patients, who have a higher risk of cardiovascular disease, infection, and complications that may arise from the comorbidities that accompany their illness. We found no association between paclitaxel device use and mortality in this group, which may reflect those patient differences, their shorter life expectancy, the morbidity that comes from repeat intervention and/or the need for indwelling venous catheters. This finding is reassuring given what we know about how effective these devices are in reducing reintervention rates, and it opens the way for physicians to continue to use these valuable tools in ensuring best outcomes for their patients."

To see all of the articles in our continuing coverage of the paclitaxel safety data review, please visit this page.

Advertisement


August 28, 2019

Enrollment Completed in Pivotal TRANSCEND Clinical Trial for Surmodics' SurVeil DCB

August 28, 2019

Enrollment Completed in Pivotal TRANSCEND Clinical Trial for Surmodics' SurVeil DCB