Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review

Krystal Dinh1, Miguel Lemos Gomes2, Shannon D Thomas2,3,4

  • 1Department of Vascular Surgery, Westmead Hospital, Sydney, NSW, Australia.

Insights

Paclitaxel-coated devices showed no significant difference in all-cause mortality compared to uncoated devices for patients with chronic limb-threatening ischemia (CLTI). This meta-analysis of randomized controlled trials suggests similar short- to midterm survival outcomes.

Area of Science:

  • Vascular Medicine and Interventional Cardiology
  • Biomaterials and Medical Devices

Background:

  • Chronic limb-threatening ischemia (CLTI) is a severe condition associated with high mortality and morbidity.
  • Paclitaxel-coated devices are utilized in peripheral artery disease (PAD) to improve outcomes, but their impact on mortality in CLTI patients requires evaluation.

Purpose of the Study:

  • To determine the risk of all-cause mortality in patients with CLTI treated with paclitaxel-coated devices versus uncoated controls.

Main Methods:

  • A systematic literature search of multiple databases (PubMed, Embase, Cochrane, etc.) was conducted up to November 5, 2019.
  • Included were randomized controlled trials (RCTs) comparing paclitaxel-coated devices to uncoated devices in PAD patients with at least 6-month follow-up, focusing on CLTI or CLTI subgroups.
  • All-cause mortality was the primary endpoint, analyzed using a random effects model, with results expressed as relative risk ratios (RR) and 95% confidence intervals (CI).

Main Results:

  • Eleven RCTs comprising 1450 patients (866 paclitaxel-coated, 584 uncoated) were analyzed; 94.3% of patients had CLTI.
  • The mean follow-up duration was 25.6 months.
  • There was no statistically significant difference in all-cause mortality between the paclitaxel-coated device group (18.6% deaths) and the uncoated control group (19.9% deaths), with an RR of 0.93 (95% CI 0.78 to 1.12, p=0.45).

Conclusions:

  • The study found no significant difference in short- to midterm all-cause mortality for CLTI patients treated with paclitaxel-coated devices compared to uncoated controls.
  • These findings suggest comparable survival rates between the two treatment strategies in this high-risk patient population.
Abstract

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