BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee.
The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb through 30 days—was met in both the proportional and binary and Kaplan Meier analyses of patient survival following a medical procedure. BD presented the trial results during a late-breaking clinical trials session at the Vascular Interventional Advances (VIVA) conference in Las Vegas.
“The six-month clinical data from the Lutonix BTK trial represent the beginning of a paradigm shift in the treatment of patients with critical limb ischemia (CLI),” said Jihad Mustapha, M.D. of the Advanced Cardiac and Vascular Amputation Centers in Grand Rapids, Mich., in a prepared statement. “The initial results are extremely encouraging and give new hope to patients with CLI.”
The prospective, global, multicenter, randomized, controlled trial used a composite measurement of limbs saved from amputation and the openness of arteries, known as primary patency. By proportional/binary analysis, at six months there was an improvement in primary efficacy of 10.2% (DCB: 73.7% and PTA: 63.5%, p=0.0273, not-significant). The more commonly used Kaplan Meier analysis of the primary efficacy endpoint demonstrated a significant difference of 14.6% (DCB: 85.3%, PTA: 70.7%, p<0.001). Additional analyses are planned for 12-, 24- and 36-month follow-ups.
The trial included approximately 450 participants, of whom 91% had CLI, a severe form of vascular disease that seriously decreases blood flow to the lower leg arteries. An estimated 3.4 million people in the U.S. have CLI today, and the number is estimated to grow to nearly 3.8 million by 2020. CLI is associated with a six-month major amputation rate ranging from 10 % to 40% and with mortality rates as high as 50% at five years.
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.