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. 2021 Aug 23;4(1):65.
doi: 10.1186/s42155-021-00255-1.

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

Gérald Gahide  1   2   3 , Samuel C Phaneuf  4   5 , Mathilde Cossette  4   5 , Amine Banine  4   5 , Martina Budimir  4   5 , Kourosh Maghsoudloo  4   5 , Phillip Fei  4   5 , Bo Yi Dou  4   5 , Maxime Bouthillier  4   5 , Charles Alain  4   5 , Simon Bradette  4   5 , Maxime Noel-Lamy  4   5 , Francois Belzile  4   5 , Bao The Bui  4   5 , Marc Antoine Despatis  5   6 , Jean Francois Vendrell  4   5
Affiliations

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

Gérald Gahide et al. CVIR Endovasc. .

Abstract

Objective: To compare the mortality rates of patients with claudication and de novo femoropopliteal lesions treated with and without paclitaxel coated devices (PCD).

Background: A 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.

Methods: Comparison of two historical cohorts of patients presenting with claudication and de novo femoropopliteal lesions treated with and without PCD between 2008 and 2018.

Results: 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). 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.

Conclusion: 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. The current study suggests that additional prospective randomized studies properly powered to study mortality are necessary.

Keywords: Claudication; Drug coated balloon; Drug eluting stent; Mortality; Paclitaxel; Peripheral artery disease.

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Conflict of interest statement

Gerald Gahide is medical consultant for Boston Scientific. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the selection of the patients included in the study
Fig. 2
Fig. 2
Kaplan-Meier estimates of survival of the entire cohort for the POBA and DCB group through 5 years including the interval of confidence. (PCD: Paclitaxel Coated Devices; POBA: Plain Old Balloon Angioplasty)
Fig. 3
Fig. 3
Annotated Kaplan-Meier survival analysis with the relative risk-ratio (RR) at 1, 2 and 5 years of follow-up. (PCD: Paclitaxel Coated Devices; POBA: Plain Old Balloon Angioplasty)
See this image and copyright information in PMC

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