LIFE-BTK Trial Outcomes of Abbott’s Esprit BTK Scaffold in CLTI Presented With Wound Assessment Data

October 31, 2023—Results from Abbott’s LIFE-BTK randomized clinical trial (RCT) evaluating the company’s Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system in patients with chronic limb-threatening ischemia (CLTI) demonstrated that the Esprit BTK device reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current state of care.

The findings were presented by Raghu Kolluri, MD, during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

According to The VIVA press release, Abbott’s LIFE-BTK trial met its primary safety and efficacy endpoints of opening blocked BTK arteries and maintaining patency compared to balloon angioplasty alone.

Additionally, the trial collected comprehensive wound data from the CLTI population. In LIFE-BTK, wound assessment was not a prespecified powered primary or secondary endpoint but rather a prespecified descriptive endpoint. This is important, noted the press release, because there is not much evidence from other trials assessing wounds. CLTI can lead to nonhealing wounds because of reduced blood flow to the affected limb. Wound care is critical to prevent infections, promote healing, prevent further tissue damage, and minimize amputation rates.

As summarized in The VIVA press release, LIFE-BTK provided the largest ischemic wound data set to date, which was collected systematically and adjudicated independently in a blinded fashion. The wound data were assessed by experts at the wound core laboratory. The healing of the index wounds showed improvement in both arms, and the occurrence of new wounds was comparable, with no statistical difference between arms. This result highlights the fact that revascularization is not the sole factor influencing wound healing.

Additionally, it has been further demonstrated that the resorbable scaffold with an olimus-based antiproliferation drug was not associated with any disruption in wound healing over a period of time.

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