Paclitaxel-coated Devices Improve Outcomes in Patients Presenting With Chronic Limb-Threatening Ischemia

Abstract

Paclitaxel (PTX)-coated devices decrease restenosis after femoropopliteal artery intervention. Recently, they have been linked to a potential increase in late mortality and amputation based on data of patients predominantly presenting with claudication. Outcome of PTX in patients with chronic limb-threatening ischemia (CLTI) are unknown. The objective of this study was to compare outcome of CLTI patients treated with and without PTX. Patients who underwent femoropopliteal artery interventions for CLTI from January 2016 to October 2020 (n = 35,533; 13,546 treated with PTX) in the Society for Vascular Surgery Vascular Quality Initiative were reviewed. Patients were divided based on PTX exposure and propensity matched to control for differences in symptoms, comorbidities, and perioperative medications. After matching there were 13,528 patients in each cohort. Primary outcome measures of overall survival (OS), limb salvage, freedom from target vessel revascularization (TVR), and freedom from major adverse limb events (MALE) were assessed using Kaplan-Meier survival analysis. After matching there were no significant differences in baseline characteristics. At 2-year follow-up, there was no significant difference in OS between PTX and no-PTX patients (81 vs 80%; P = .07). A significant benefit was observed with PTX treatment in limb salvage (90% vs 87%; P < .001) (Fig 1), freedom from MALE (73% vs 69%; P < .001) (Fig 2), and freedom from TVR (81% vs 78%; P < .001). Multivariable Cox regression analysis confirms that PTX is associated with improved limb salvage (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.69-0.83; P < .001), freedom from MALE (HR, 0.73; 95% CI, 0.68-0.78; P < .001), and freedom from TVR (HR, 0.72; 95% CI, 0.66-0.79; P < .001), with no difference in OS (HR, 0.95; 95% CI, 1.01-0.88; P = .11). At 2 years, CLTI patients treated with a PTX-coated device demonstrated improved limb salvage, freedom from TVR, and freedom from MALE with no difference in OS. This study suggests that the use of PTX-coated devices may be beneficial to patients presenting with CLTI and are not associated with adverse outcome as suggested by recent meta-analyses.Fig 2View Large Image Figure ViewerDownload Hi-res image Download (PPT)