Abbott’s Esprit BTK Drug-Eluting Resorbable Scaffold Studied in Patients With CLTI

October 25, 2023—Abbott announced late-breaking data from the LIFE-BTK clinical trial evaluating the company’s Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system in patients with chronic limb-threatening ischemia (CLTI).

According to the company, 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 balloon angioplasty, the current standard of care.

The LIFE-BTK data were presented as a late-breaking clinical trial at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. The study was simultaneously published by Ramon L. Varcoe, MBBS, online in The New England Journal of Medicine.

Abbott stated that the LIFE-BTK trial, which enrolled 261 people worldwide, 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 of primary patency plus limb salvage was met 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 of freedom from above-the-ankle amputation, major reintervention at 6-months, and death within 30-days showed that Esprit BTK was noninferior to balloon angioplasty.

As summarized by Abbott, the 1-year LIFE-BTK results showed the following:

• Esprit BTK in patients with CLTI had a significantly greater freedom from the primary efficacy clinical events versus balloon angioplasty (74.5% vs 43.7%).
• The trial’s powered secondary endpoints revealed that Esprit BTK was superior to balloon angioplasty at reducing vessel renarrowing (25.8% improvement) and sustaining openness of the vessels (14.2% improvement).

The company advised the Esprit BTK is an investigational device, limited by United States law to investigational use only. 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 FDA.

“Millions of people suffer from peripheral artery disease (PAD). Yet, in the United States, there are currently no approved drug-eluting stents, drug-coated balloons, or bare metal stents available for use below-the-knee,” commented Brian DeRubertis, MD. “This underscores a pressing and substantial need for improved treatment options for people with CLTI and PAD. Results from the LIFE-BTK trial highlight the efficacy of Esprit BTK and its potential to deliver significant benefits in terms of opening blocked arteries below-the-knee and providing sustained treatment over time.”

Dr. DeRubertis, who is from New York Presbyterian-Weill Cornell Medical Center in New York, New York, is one of the principal investigators in the trial.