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May 3, 2020

Adjusted and Case-Matched Analysis Evaluates Association of Paclitaxel and Mortality After Peripheral Angioplasty

May 3, 2020—An adjusted and case-matched multicenter analysis of paclitaxel and mortality after peripheral angioplasty found that when relevant risk factors were taken into account, there were no associations between paclitaxel and midterm mortality in patients with peripheral arterial occlusive disease (PAOD).

The study by Athanasios Saratzis, MBBS, et al was published online ahead of print in European Journal of Vascular & Endovascular Surgery (EJVES).

The current investigation was conducted in the wake of recent findings that suggested paclitaxel-based drug-coated balloons (DCB) and drug-eluting stents (DES) may be associated with increased mortality in patients with PAOD. However, the earlier meta-analysis had a number of limitations that have been discussed at great length among the vascular community, noted the investigators.

The aim of Dr. Saratzis and colleagues was to assess the association between paclitaxel-based endovascular treatment (PTX) in the femoropopliteal segment and mortality, adjusting for relevant risk factors and including patients with chronic limb-threatening ischemia (CLTI).

As summarized in EJVES, this is a retrospective cohort study of a prospectively maintained multicenter database of patients with claudication or CLTI. The analysis included patients treated by femoropopliteal angioplasty with or without paclitaxel between January 1, 2014, and May 30, 2019.

Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case-matched (based on each individual’s Charlson index) analysis was performed to compare mortality rates between those who received paclitaxel and those who did not.

The analysis was composed of a total of 2,071 patients from three sites. Of these patients, 952 (46%) had CLTI and 1,119 (54%) had severe claudication (Rutherford stage 3). There were 966 patients (46.6%) treated with PTX.

At 24-month median follow-up, the investigators reported the following:

  • 456 (22.1%) patients died
  • Paclitaxel was not associated with mortality (hazard ratio [HR], 0.94; P = .46), using multivariable Cox regression
  • Paclitaxel was not associated with mortality even when assessed separately for those with intermittent claudication (HR, 1.3; P = .15) or CLTI (HR, 0.81; P = .06)
  • Paclitaxel was not associated with mortality in the case-matched analysis of 885 matched pairs of patients (HR 0.89; P = .17)

Additionally, paclitaxel dose and the use of a DCB or DES were not associated with mortality in any subanalysis, noted the investigators in EJVES.

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