Abbott’s Espirit BTK System Outperforms Angioplasty in PAD Patients With Chronic Limb-Threatening Ischemia

Abbott has announced late-breaking data from the LIFE-BTK clinical trial, showcasing the potential of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK) in treating people with chronic limb-threatening ischemia (CLTI), a severe stage of peripheral artery disease (PAD). The trial, which addresses the unmet medical needs of a large patient population, met its primary safety and effectiveness endpoints, signaling that Esprit BTK has the capacity to significantly reduce the progression of the disease and improve clinical outcomes compared to the current standard of care, which is balloon angioplasty. The data from the LIFE-BTK trial was presented as a late-breaking clinical trial at the 35th Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco and was simultaneously published in the New England Journal of Medicine.

Peripheral artery disease (PAD) affects more than 200 million people worldwide, with nearly 11% of them experiencing CLTI, a severe form of PAD. CLTI arises when blocked vessels impede blood flow to the lower extremities, leading to severe pain, non-healing wounds, and, in some cases, the need for limb amputation. Currently, balloon angioplasty is one of the approved treatment options for people in the U.S. with CLTI. However, this procedure often requires additional treatment in the future because the vessels become blocked again over time.

Abbott’s Esprit BTK is a drug-eluting resorbable scaffold made from materials similar to dissolving sutures. Unlike permanent metal stents, Esprit BTK offers temporary support to the cleared vessel for a few months, after which the vessel can stay open on its own.

The LIFE-BTK trial, which enrolled 261 participants from around the world, aimed to determine whether Esprit BTK could outperform the current standard of care, balloon angioplasty, in reopening and maintaining open arteries in the leg. The trial’s primary efficacy endpoint, which evaluated primary patency plus limb salvage, showed that Esprit BTK was 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 results of the one-year LIFE-BTK clinical trial demonstrated that Esprit BTK had significantly higher freedom from primary efficacy clinical events (74.5%) for people with CLTI compared to balloon angioplasty (43.7%).  The primary safety endpoint showed that Esprit BTK was non-inferior to balloon angioplasty, which means they performed similarly.

The trial also revealed that Esprit BTK was better at reducing vessel re-narrowing and maintaining the openness of the vessels. Abbott plans to submit the Esprit BTK Everolimus Eluting Resorbable Scaffold System for review by the U.S. Food and Drug Administration (FDA).