A Single-Center Experience of Paclitaxel in the Treatment of Femoropopliteal Disease—No Evidence for an Association With Mortality

Abstract

Purpose: Paclitaxel-coated devices have been increasingly used in endovascular treatment of femoropopliteal disease as they limit recurrence of lesions and improve patient outcomes. However, a recent meta-analysis reported that these devices increase mortality risk at 2 years post-intervention but did not account for confounding variables. Therefore, our goal was to evaluate mortality after paclitaxel treatment of femoropopliteal disease using patient-level data. Methods: We performed a retrospective review of all patients who received endovascular treatment for femoropopliteal lesions at our center between December 2009 and July 2017. There were 388 patients in the paclitaxel group and 314 control patients. Results: Survival analysis with hazard ratios showed no difference between mortality in the paclitaxel and control groups. Age, renal insufficiency, and chronic limb-threatening ischemia were significant predictors of mortality. We also used logistic regression to evaluate mortality at 1, 2, and 5 years post-intervention and found no difference between the paclitaxel and control groups at any time point, while age, renal insufficiency, and chronic limb-threatening ischemia at the time of intervention were all associated with the risk of death. Finally, we tallied the causes of death in our cohort and found no difference in the distribution of causes between groups. Conclusion: Our single-center, retrospective study provides no evidence of increased risk of death with paclitaxel treatment in femoropopliteal disease. Contrastingly, age, renal insufficiency, and chronic limb-threatening ischemia were the most important factors contributing to mortality and therefore should be included as potential confounders in future studies assessing mortality in femoropopliteal disease.

A Single-Center Study on the Outcomes of Target Limb Revascularization in Femoropopliteal Lesions Treated With Drug Coated Balloons and Bare Metal Stents

“…20,27 In addition, there remains a question about increased mortality risk with paclitaxel DCBs, although we have no evidence to support this in our patient population. 17 There were several limitations to our study. One limitation was the retrospective nature of the study in which clinical judgment may have introduced selection bias into treatment groups as discussed above.…”

“…13 However, our patient population does not show evidence of increased mortality. 17 Moreover, large studies that include patient-level data do not find an association with drug coated devices and death. [14][15][16] To summarize, the decision to treat femoropopliteal lesions either with BMSs or DCBs is complex.…”

“… 13 However, our patient population does not show evidence of increased mortality. 17 Moreover, large studies that include patient-level data do not find an association with drug coated devices and death. 14 – 16 …”

“… 20 , 27 In addition, there remains a question about increased mortality risk with paclitaxel DCBs, although we have no evidence to support this in our patient population. 17 …”

“…This dataset was analyzed in a previous study on the risk of mortality in our patient population. 17 For the purposes of this article, we used a subset of these data to compare lesions treated with BMSs and DCBs, excluding lesions treated with PBA and DESs. Exclusion criteria were patients who died during the follow-up period, patients lost to follow-up, patients who had the respective limb amputated within 60 days (revascularization was likely performed for post-op healing), lesions treated with DCBs that required bail-out stenting, and lesions with missing data.…”