Abbott announces late-breaking data from LIFE-BTK clinical trial

Abbott announced late-breaking data from the LIFE-BTK clinical trial evaluating the Esprit BTK Everolimus Eluting Resorbable Scaffold System in people with chronic limb-threatening ischemia. CLTI is a severe stage of peripheral artery disease due to advanced arterial blockage in the lower extremities. The LIFE-BTK trial met both of its primary safety and effectiveness endpoints, demonstrating that Esprit BTK reduces disease progression and helps improve medical outcomes compared to the current standard of care, balloon angioplasty. Data from LIFE-BTK was presented as a late-breaking clinical trial at the 35th Transcatheter Cardiovascular Therapeutics Conference in San Francisco and simultaneously published in the New England Journal of Medicine. The LIFE-BTK trial enrolled 261 people worldwide. The study aimed to investigate whether Esprit BTK could offer greater benefits than the current option of balloon angioplasty to open blocked arteries in the leg and to keep the arteries open. The trial’s primary efficacy endpoint evaluated primary patency plus limb salvage. The trial met the efficacy endpoint and showed that Esprit BTK is superior to balloon angioplasty in lowering the risk of total obstruction of the target vessel, narrowing of the target lesion, major amputation and repeat interventions of the target lesion. The primary safety endpoint evaluating freedom from above-the-ankle amputation, major reintervention at six-months and death within 30-days showed that Esprit BTK was non-inferior to balloon angioplasty. Based on the strength of the LIFE-BTK trial results, Abbott intends to submit the Esprit BTK Everolimus Eluting Resorbable Scaffold System for review by the U.S. Food and Drug Administration.