Outcome after revascularization with paclitaxel-coated devices in patients with chronic limb-threatening ischemia

Objective: Data regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. Methods: We retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. Results: Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P < .001), primary patency (80.3% vs 76.9%; P < .001), and freedom from MALE (72.6% vs 67.9%; P < .001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P < .001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P < .001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P < .001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P = .07), but significant in the de-novo treated patients (73.9% vs 70.7%; P = .02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P = .02). Conclusions: FPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome.