November 7, 2018—BD (Becton, Dickinson and Company) announced the safety and efficacy data from the level 1 investigational device exemption clinical trial of the company's Lutonix drug-coated balloon (DCB) for a below-the-knee (BTK) indication. These late-breaking data were presented at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.
According to the company, the prospective, global, multicenter, randomized controlled trial compared the Lutonix 014 DCB to standard angioplasty for the treatment of narrowed or obstructed arteries below the knee. The clinical study was composed of approximately 450 participants, of which 91% had critical limb ischemia (CLI). Investigators used both proportional/binary and Kaplan-Meier analyses to assess safety and efficacy.
The investigators found that the study's primary safety endpoint (freedom from a composite of all-cause death and above-the-ankle or major reintervention of the treated limb through 30 days) was met and showed statistically significant safety equivalence between the Lutonix 014 DCB and a standard percutaneous transluminal angioplasty (PTA) catheter in both the proportional/binary and Kaplan-Meier analyses.
The primary efficacy endpoint was assessed using a composite measurement of limbs saved from amputation and primary patency. By proportional/binary analysis at 6 months, there was an improvement in primary efficacy of 10.2% for DCB compared to PTA (73.7% vs 63.5%; P = .0273, not significant). As measured by Kaplan-Meier analysis, the primary efficacy endpoint demonstrated a significant difference of 14.6% for DCB compared to PTA (85.3% vs 70.7%; P < .001). Additional analyses are planned for 12-, 24- and 36-month follow-up.
Jihad Mustapha, MD, commented in the company's announcement, "The 6-month clinical data from the Lutonix BTK trial represent the beginning of a paradigm shift in the treatment of patients with CLI. The initial results are extremely encouraging and give new hope to patients with CLI." Dr. Mustapha is with Advanced Cardiac and Vascular Amputation Centers in Grand Rapids, Michigan.
The Lutonix 014 DCB has been commercially available in Europe, Canada, and Australia for treatment of the below-the-knee arteries associated with CLI since 2013, advised the company.