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Lutonix Safety Data Shows No Increase in Death with DCB vs PTA

Lutonix Safety Data Shows No Increase in Death with DCB vs PTA

Author Information:

Debra L. Beck


Hollywood, FL (January 23, 2020) – In a pooled analysis that included more than 1000 patients treated with the Lutonix 035 drug-coated balloon (DCB) (BD), no increase in mortality risk was seen compared to those treated with uncoated balloon angioplasty.   

“I would venture to say from this study that we've seen that there is continued meaningful benefit from the Lutonix system relative to risk in patients with PAD,” said presenter Constantino Pena, MD, of the Miami Cardiac & Vascular Institute.

At 5 years, the hazard ratio for survival in the aggregated Lutonix trials was 1.01 with no adjustment, and 1.16 in a propensity analysis (both P values were non-significant).

Patients in both groups who underwent any subsequent intervention had higher survival rates than those who did not undergo reinterventions.

Dr. Pena noted that, rather than there being a signal of greater harm with greater paclitaxel exposure (from reintervention), it seemed to be protective, and this was seen in both arms. “Subsequent intervention involves addition interactions with health care providers,” he noted.

This safety analysis was conducted by the independent contract research organization Syntactx, and used updated data on the Lutonix DCB, including data the company recovered on 29 subjects previously lost to follow-up. This effort yielded a follow-up rate of 88% at 5 years for LEVANT 2.

The researchers sliced and diced the data several different ways — looking at whether there might be a clustering of causes of death which suggest a common mechanism for paclitaxel-associated mortality; assessing whether there might be patient- or treatment-related variables associated with increased risk, or a dose-risk relationship — and no matter which way they looked at the data, no statistically significant increase in the hazard ratio for mortality was seen, said Dr. Pena.

There were several baseline covariates that were found to predict mortality, including the usual culprits: age, prior treatment of target lesion, arrhythmia, and diabetes. “However, the use of DCB as compared to PTA was not a significant predictor of mortality,” reported Dr. Pena.

Of note, no dose-response relationship was identified when adjusted for key predictors of mortality.

Lutonix was the first DCB approved by the FDA. To date, more than 400,000 patients have been treated worldwide with this device, including about 3,400 in clinical trials.

LEVANT 2 is the largest cohort of 5-year follow-up data in patients treated with DCBs.

The Lutonix Syntactyx Safety Analysis presented at ISET assessed safety outcomes of femoropopliteal drug-coated balloon angioplasty using patient-level data from the Lutonix clinical program. To this end, the researchers evaluated data on DCB angioplasty (n=1093) and uncoated balloon angioplasty (n=250) outcomes from 3 different trials: 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.

This pooled analysis was published in the December 2019 issue of JACC Cardiovascular Interventions.1


  1. Ouriel K, Adelman MA, Rosenfield K, et al. Safety of paclitaxel-coated balloon angioplasty for femoropopliteal peripheral artery disease. J Am Coll Cardiol Intv. 2019; 12: 2515-2524.
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