Abbott Releases Late-Breaking Data on Its Esprit BTK System

Abbott announced late-breaking data from the second year of the LIFE-BTK clinical trial. Data demonstrated the long-term effectiveness of the Esprit BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK) in people with the most severe form of peripheral artery disease (PAD) below the knee (BTK). The data showed that Abbott’s Esprit BTK System offered sustained benefits over balloon angioplasty (a common treatment for PAD) with fewer repeat procedures in two years.

The Esprit BTK System is an FDA-approved, first-of-its-kind dissolvable stent to treat PAD below the knee. It consists of a material similar to dissolving sutures that help heal the vessel once the blockage is opened and provides support until the vessel is strong enough to remain open on its own.

“The positive results at two years reinforce Esprit BTK’s potential to revolutionize the treatment of peripheral artery disease below the knee,” said Jennifer Jones-McMeans, divisional vice president of global clinical affairs at Abbott’s vascular business. “We’re proud to be at the forefront of developing innovative treatment options for the millions of people living with PAD. By eliminating the need for multiple interventions and in some cases, amputation, we’re ultimately helping people live fuller, better lives.”

The LIFE-BTK trial evaluated if the Esprit BTK could offer greater long-term benefits than balloon angioplasty, the current standard of care for PAD below the knee. Balloon angioplasty offers poor short- and long-term outcomes and can result in the vessels becoming blocked again, requiring additional interventions.

The data from the trial showed strong two-year results when compared to other therapies. The trial’s primary efficacy endpoint evaluated the ability of the vessel to stay open and lengthen the time until another intervention is needed.

The two-year data from the LIFE-BTK trial, which evaluated Esprit BTK in more than 260 people worldwide with PAD below the knee, was presented as a late-breaking clinical trial at VIVA 2024 in Las Vegas.

Key Results

• The trial showed sustained efficacy at 24 months, demonstrating that Esprit BTK’s long-term durability is effective in reducing reclosures and promoting the vessel to stay open.
• At one year, the trial’s powered secondary endpoints revealed that Esprit BTK had a higher rate of reducing vessel re-narrowing (35.2% improvement) compared to balloon angioplasty.
• Compared to balloon angioplasty, people treated with Esprit BTK had significantly greater freedom from chronic limb-threatening ischemia (a severe form of PAD), which was the primary efficacy clinical event, 61.5% vs 32.8%. 
• 90.3% of patients in the Esprit BTK arm did not require a reintervention at 24 months.

Abbott also launched the Esprit BTK Post-Approval Study (PAS) to assess the continued safety and effectiveness of Esprit BTK in treating chronic limb-threatening ischemia (CLTI) patients with blocked arteries below the knee in a real-world setting. The first patient was enrolled by Bernardino L. Rocha, M.D., a vascular surgeon at SSM Health Heart & Vascular Care in Oklahoma City, Oklahoma.