BD Announces Findings Supporting the Safety of Lutonix Paclitaxel-Coated Balloon

September 28, 2019—BD (Becton, Dickinson and Company) announced that findings from a company-initiated, independent analysis of its Lutonix 035 drug-coated balloon (DCB) femoropopliteal clinical program were published online by Kenneth Ouriel, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions and simultaneously presented in a late-breaking trial session at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 25–29 in San Francisco, California.

According to the company, the independent analysis evaluated safety outcomes for the Lutonix 035 DCB (n = 1,093) versus standard percutaneous transluminal angioplasty (n = 250). The study used patient-level data and propensity matching from three Lutonix DCB randomized controlled trials: LEVANT 1, LEVANT 2, and LEVANT Japan, as well as the Continued Access cohort of the LEVANT 2 trial. The investigators reported that the findings confirmed there was no statistically significant increase in mortality with use of the Lutonix 035 DCB.

Dr. Ouriel is President and CEO of Syntactx, the clinical research firm that conducted the independent analysis. He commented in BD's announcement, “While the FDA and Advisory Committee of Circulatory System Devices Panel in June identified a late mortality signal after treatment with paclitaxel-coated devices using a meta-analysis of randomized controlled trials at 5 years from multiple companies, they recognized the benefits of these devices, including fewer reinterventions. They agreed that the magnitude of the signal should be interpreted with caution due to multiple limitations in the available data."

He continued, "This large patient-level analysis found no statistically significant increase in mortality associated with Lutonix DCB treatment. Lutonix DCB remains a viable medical therapy for patients with peripheral arterial disease who demonstrate a high risk for restenosis and repeat femoropopliteal interventions."

Additionally, the company advised that a medical advisory committee composed of an interventionalist and oncologist reevaluated the cause of death in the LEVANT 1 and LEVANT 2 trials, including the LEVANT 2 Continued Access cohort. This independent review confirmed through adjudication that zero deaths were determined to be related to paclitaxel. Moreover, no clustering or pattern of death in any cardiovascular or noncardiovascular categories was observed, which would have indicated a causal relationship between paclitaxel and death, reported BD.