Paclitaxel and mortality in patients with claudication and de novo femoropopliteal lesions: a historical cohort study

Gérald Gahide,Mathilde Cossette,Martina Budimir,Phillip Fei,Bao The Bui,Samuel C Phaneuf,Charles Alain,Amine Banine,Bo Yi Dou,Maxime Noel-Lamy,Marc Antoine Despatis,Simon Bradette,Francois Belzile,Kourosh Maghsoudloo,Jean Francois Vendrell,Maxime Bouthillier

doi:10.1186/s42155-021-00255-1

Gérald Gahide, Mathilde Cossette + Show 14 more

Open Access

https://doi.org/10.1186/s42155-021-00255-1

Copy DOI

Abstract

ObjectiveTo compare the mortality rates of patients with claudication and de novo femoropopliteal lesions treated with and without paclitaxel coated devices (PCD).BackgroundA recent meta-analysis, mostly including patients with claudication and de novo femoropopliteal lesions but also with recurrent stenoses and critical limb ischemia, has shown a significant excess mortality in patients treated with PCD.MethodsComparison of two historical cohorts of patients presenting with claudication and de novo femoropopliteal lesions treated with and without PCD between 2008 and 2018.ResultsAfter review of 5219 arteriograms in patients presenting with peripheral artery disease, 700 consecutive patients were included consisting in 72.6% of male (n = 508). Mean age was 68.1 ± 8.5 years. 45.7% of the patients (n = 320) had a treatment including a PCD. Mean femoropopliteal lesion length was 123 ± 91 mm including 44.6% of occlusions. Patients of the control group were censored at crossover to paclitaxel when applicable. Mortality rates at 1, 2 and 5 years were 4.6%, 7.5%, 19.4% and 1.6%, 6.2%, 16.6% in the non-PCD and PCD groups respectively. The relative risks of death when using PCD were 0.35 (p = 0.03), 0.83 (p = NS) and 0.86 (p = NS) at 1, 2 and 5 years respectively.ConclusionThere was no excess mortality in patients with claudication and de novo femoropopliteal lesions treated with paclitaxel coated devices at 1, 2 and 5 years of follow-up in this cohort. The current study suggests that additional prospective randomized studies properly powered to study mortality are necessary.

Highlights

A recent meta-analysis, mostly including patients with claudication and de novo femoropopliteal lesions and with recurrent stenoses and critical limb ischemia, has shown a significant excess mortality in patients treated with paclitaxel-coated devices (PCD)
After review of 5219 arteriograms in patients presenting with peripheral artery disease, 700 consecutive patients were included consisting in 72.6% of male (n = 508)
There was no excess mortality in patients with claudication and de novo femoropopliteal lesions treated with paclitaxel coated devices at 1, 2 and 5 years of follow-up in this cohort

Summary

Introduction

A recent meta-analysis, mostly including patients with claudication and de novo femoropopliteal lesions and with recurrent stenoses and critical limb ischemia, has shown a significant excess mortality in patients treated with PCD. The multidisciplinary VIVA physician group did an impressive work in close collaboration with industry. They comprehensively reanalyzed the data of 8 prospective randomized clinical trials (Rocha-Singh et al 2020). After this thorough reanalysis, they demonstrated a signal of excess mortality at 5 years in the PCD group. It is of importance to note that both meta-analyses were based upon studies that included patients with de novo claudication, recurrent stenoses and critical limb ischemia

Methods

Results

Discussion

Conclusion