Elsevier

JACC: Cardiovascular Interventions

Volume 13, Issue 17, 14 September 2020, Pages 2052-2061
JACC: Cardiovascular Interventions

Peripheral
Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World

https://doi.org/10.1016/j.jcin.2020.04.050Get rights and content
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Abstract

Objectives

This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice.

Background

A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.

Methods

A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed.

Results

Overall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007).

Conclusions

In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.

Key Words

angioplasty
drug-coated balloon
femoropopliteal artery
mortality
paclitaxel

Abbreviations and Acronyms

DCB
drug-coated balloon
PAD
peripheral artery disease
POBA
plain old balloon angioplasty
RBC
Rutherford-Becker class
RCT
randomized controlled trial

Cited by (0)

Dr. Noory has received honoraria from BARD, Boston Scientific, Abbott, and Medtronic. Dr. Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, Gore and Associates, Medtronic, Philips-Spectranetics, BIBA Medical, and Shockwave; has served as a consultant for Boston Scientific, Gore and Associates, Medtronic, Veryan, CSI Medical, Intact Vascular, Shockwave, Bayer, and Vesper Medical; has received research, clinical trial, or drug study funds received from 480 Biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore and Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, and B. Braun; and owns common stock in QT Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.