Document Type
Article
Publication Title
Circulation
Abstract
BACKGROUND: Limited treatment options exist for infrapopliteal disease in patients with chronic limb-threatening ischemia (CLTI), a condition associated with a high risk of limb loss. Interventional management of diseased infrapopliteal vessels with percutaneous transluminal angioplasty (PTA) is associated with high rates of restenosis and reintervention. In the LIFE-BTK randomized controlled trial (Pivotal Investigation of Safety and Efficacy of BRS Treatment-Below the Knee), the drug-eluting resorbable scaffold (DRS) demonstrated superior 12-month efficacy compared with PTA in a selected CLTI population with predominantly noncomplex, mildly to moderately calcified lesions. This report presents the 2-year safety and efficacy outcomes of the Esprit BTK DRS system in the LIFE-BTK randomized trial comparing DRS with PTA for treatment of infrapopliteal vessels and CLTI.
METHODS: The LIFE-BTK trial was a multicenter, subject-blinded, randomized controlled trial enrolling 261 patients with CLTI who were randomized 2:1 to receive either DRS or PTA. The revised primary efficacy end point was freedom from target limb amputation, target vessel occlusion, clinically driven target lesion revascularization, or binary restenosis. The primary safety end point was freedom from major adverse limb events and perioperative death. Predictors of efficacy and clinically driven target lesion revascularization were analyzed along with subgroup assessments.
RESULTS: At 2 years, the primary efficacy end point was observed in 68.8% of the DRS group versus 45.4% of the PTA group (
CONCLUSIONS: At 2 years, the Esprit BTK DRS demonstrated improved efficacy compared with PTA in maintaining arterial patency, preventing restenosis, and reducing revascularization rates while maintaining a comparable safety profile. These findings support the Esprit BTK scaffold as a promising treatment option for appropriately selected patients with infrapopliteal artery disease and CLTI.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04227899.
First Page
1076
Last Page
1086
DOI
10.1161/CIRCULATIONAHA.125.075080
Publication Date
10-14-2025
Recommended Citation
DeRubertis BG, Varcoe RL, Krishnan P, Bonaca MP, O'Connor DJ, Pin R, Metzger DC, Holden A, Lee JK, Iida O, Armstrong EJ, Kum SWC, Kolluri R, Bajakian DR, Garcia LA, Shishehbor MH, Yu S, Ruster K, Martinsen BJ, Igyarto Z, Parikh SA. Drug-Eluting Resorbable Scaffold Versus Balloon Angioplasty for Below-the-Knee Peripheral Artery Disease: 2-Year Results From the LIFE-BTK Trial. Circulation. 2025 Oct 14;152(15):1076-1086. doi: 10.1161/CIRCULATIONAHA.125.075080. Epub 2025 Sep 10. PMID: 40927852; PMCID: PMC12513053.