Paclitaxel in real-life data is not associated with reduced survival but has limited benefit in preventing amputation

BACKGROUND: Recent meta-analysis of randomized-controlled trials reported an increased risk of long-term mortality in patients treated with paclitaxel-coated devices (PCD) for femoropopliteal arteries (FP) lesions. However, real-life data on the subject is contradictory and data from CLTI patients is missing. The authors aim to evaluate the impact of PCD for the treatment of FP lesions on long-term mortality and amputation on a real-life cohort up to 5 years.

METHODS: All patients treated for FP lesions with endovascular devices from January 2013 to December 2016 were included, irrespective of clinical presentation. Primary endpoint is overall survival. Secondary endpoints are freedom-from major amputation and amputation-free survival. Survival estimates were obtained using Kaplan-Meier plots and a multivariable model was constructed to correct for relevant baseline differences.

RESULTS: From 2013 to 2016, 351 patients with FP lesions were treated, 250 with uncoated devices (nPCD) and 101 with PCD. Patients treated with nPCD were significantly older, more often female and with more severe degrees of ischemia. Median follow-up was 55(20-71) months. Overall survival and amputation-free survival were significantly higher in patients treated with PCD. Survival at one-year was 79% vs. 92%, at two-years 69% vs. 79% and at five-years 50% vs. 65% (P=.02). AFS was 43% vs. 57% at 5-years(P=.016). Freedom-from major amputation was similar between groups. After correction for relevant baseline differences on multivariable analysis, the survival advantage for patients treated with PCD was lost at 2 and 5 years.

CONCLUSIONS: Our results do not confirm the findings of increased mortality associated with PCD. However, no improvement in amputation rate was found. For the time, our institutional data does not support withholding PCD to reduce mortality but suggests that the benefit in preventing amputation is not significant.