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Paclitaxel-Coated Balloons for Femoropopliteal Disease
Study Questions:
What are the safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program?
Methods:
The investigators evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling.
Results:
There were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI], 0.68-1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI, 0.25-3.95) in LEVANT 1, 1.40 (95% CI, 0.62-3.14) in LEVANT 2, and 0.32 (95% CI, 0.05-1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI, 0.94-2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR, 1.03 per year; p < 0.0001), prior treatment of target lesion (HR, 1.67; p = 0.022), arrhythmia (HR, 1.65; p = 0.031), and diabetes (HR, 1.18; p = 0.047), without differences between the two arms. No dose-response relationship was identified when adjusted for key predictors of mortality.
Conclusions:
The authors concluded that in their analysis, there were no mortality differences between DCB angioplasty and PTA.
Perspective:
This analysis of individual patient-level data from the full LEVANT data set reports no increase in mortality with the use of DCBs. While this publication reports granular data specific to the Bard Lutonix DCB, there are currently multiple discordant analyses reporting both increased as well as no difference in mortality with DCBs. The August 7, 2019 Food and Drug Administration (FDA) recommendations provide excellent guidance for clinicians and state that physicians should discuss the risks and benefits of all available peripheral artery disease treatment options with patients. And for many patients, alternative treatment options to paclitaxel-coated devices provide a more favorable benefit-risk profile based on currently available information. Paclitaxel-eluting stents or balloons should continue to be used where benefits outweigh the risks. Given contradictory data, additional prospective studies are indicated to assess potential mortality risk with paclitaxel-eluting devices.
Clinical Topics: Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Interventions and Vascular Medicine
Keywords: Angioplasty, Angioplasty, Balloon, Arrhythmias, Cardiac, Diabetes Mellitus, Drug-Eluting Stents, Femoral Artery, Paclitaxel, Peripheral Arterial Disease, Risk Assessment, Secondary Prevention, Survival Rate, Stents, Vascular Diseases, Vascular Access Devices
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