FRANKLIN LAKES, N.J., Nov. 7, 2018 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the safety and efficacy data from the LUTONIX® Drug-Coated Balloon (DCB) IDE, level 1 clinical trial for a below-the-knee (BTK) indication.
The clinical study is a prospective, global, multicenter, randomized, controlled trial comparing the LUTONIX® 014 DCB to standard angioplasty for the treatment of narrowed or obstructed arteries below the knee. The study used both proportional/binary and Kaplan Meier analyses to assess safety and efficacy. The primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb through 30 days—was met showing statistically significant safety equivalence between the LUTONIX® 014 DCB and standard PTA catheter, in both the proportional/binary and Kaplan Meier analyses.
"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, MD, FACC, FSCAI, Advanced Cardiac and Vascular Amputation Centers, Grand Rapids, Mich. "The initial results are extremely encouraging and give new hope to patients with CLI."
The primary efficacy endpoint was assessed using 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.
These late-breaking data were presented at the Vascular Interventional Advances (VIVA) 2018 Annual Conference in Las Vegas. The trial included approximately 450 participants of which 91 percent 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.i CLI is associated with a six-month major amputation rate ranging from 10 percent to 40 percent and with mortality rates as high as 50 percent at five years.ii
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.
About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to better diagnose disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.
i Yost, Mary. United States Critical Limb Ischemia by Rutherford Category Prevalence and Markets in Patients and Limbs, The Sage Group. 2018.
ii Teraa M, et al. Critical Limb Ischemia: Current Trends and Future Directions J Am Heart Assoc. 2016;5:e002938.