ISET 24 - Dr Sahil Parikh (Columbia University College of Physicians and Surgeons, US) joins us to discuss the LIFE-BTK Study (NCT04227899) in context, considering the changing landscape of below-the-knee (BTK) interventions and potential uses of resorbable scaffold technology in 2024.
Sponsored by Abbott, LIFE-BTK is a pivotal randomized controlled trial evaluating the safety and efficacy of the everolimus-eluting Esprit BTK System for treating critical limb ischemia (CLI). 255 participants were enrolled in the trial and were randomized 2:1 to receive either the Esprit Device or balloon angioplasty.
The primary endpoint was a composite of limb salvage and primary patency at one year, including freedom from amputation, total occlusion of the target vessel, and clinically-driven target lesion revascularization. This outcome was met in 74% of patients in the everolimus-eluting resorbable scaffold group, as compared to 44% in the angioplasty group. In terms of safety outcomes, freedom from major adverse limb events at 6 months occurred in 97% of the everolimus-eluting resorbable scaffold group, as compared to 100% of the angioplasty group.
Interview Questions:
1. What was the landscape for BTK interventions at the outset of LIFE-BTK, and how has this changed since?
2. Could you tell us a bit about the timeline of resorbable scaffold technology, and where we are now?
3. Please remind us of the study design, patient population and inclusion criteria of LIFE-BTK.
4. What are the key results from this study, and were there any safety signals?
5. How do you view the results of this study in light of the findings of BASIL 2 and BEST-CLI?
6. What are the next steps for the use of this technology?
Recorded remotely from New York, 2024.
Support: This is an independent interview conducted by Radcliffe Vascular.
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