The LIFE-BTK Study is a prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the investigational Esprit™ BTK Everolimus Eluting Resorbable Scaffold System vs percutaneous transluminal angioplasty (PTA)† for the treatment of infrapopliteal arterial disease in patients with chronic limb-threatening ischemia (CLTI).
Varcoe, R. Primary Outcomes of the Esprit™ BTK Drug-Eluting Resorbable Scaffold for the Treatment of Infrapopliteal Lesions: The LIFE-BTK Trial. Presented at TCT 2023
* clinicaltrials.gov/study/NCT04227899
** Follow up focused on index wound assessment
† defined as Percutaneous Transluminal Angioplasty
Varcoe, R. Primary Outcomes of the Esprit™ BTK Drug-Eluting Resorbable Scaffold for the Treatment of Infrapopliteal Lesions: The LIFE-BTK Trial. Presented at TCT 2023
AA: African American | NH: Native Hawaiian | PI: Pacific Islander | NA: North American Native/American Indian | AN: Alaska Native
Varcoe, R. Primary Outcomes of the Esprit™ BTK Drug-Eluting Resorbable Scaffold for the Treatment of Infrapopliteal Lesions: The LIFE-BTK Trial. Presented at TCT 2023
Results driven by reduced binary restenosis, total occlusion and CD-TLR as part of the composite endpoint.
The primary safety endpoint was met.
Varcoe, R. Primary Outcomes of the Esprit™ BTK Drug-Eluting Resorbable Scaffold for the Treatment of Infrapopliteal Lesions: The LIFE-BTK Trial. Presented at TCT 2023
NOTE: Post-hoc subgroup analysis by lesion length terciles was conducted where no pre-specified hypothesis testing was completed to provide a p-value.
Varco, Ramon L., et. al. "Supplementary Appendix." In "Drug-eluting resorbable scaffold versus angioplasty for infrapopliteal artery disease." New England Journal of Medicine. 390 (2024): 9-19.
Resorbable scaffold backbone comprised of 100% poly (L-lactide) (PLLA) and strut thickness of 99µm**
Coating comprised of the active pharmaceutical ingredient everolimus and resorbable poly (D,L- lactide) (PDLLA)
Four platinum markers of the same mass, two each embedded at the proximal and distal ends of the scaffold for radiopacity†
** ≤ 3.0 mm size; 3.5-3.75 mm sizes have 120 µm strut thickness.
† Platinum markers at proximal and distal ends remain for angiographic visualization
Data on file at Abbott.
Photos on file at Abbott.
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