Data from Pharmawand - Curated by EPG Health - Date added 08 November 2018
BD (Becton, Dickinson and Company) 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 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 ( critical limb ischemia), a severe form of vascular disease that seriously decreases blood flow to the lower leg arteries.0>