Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia: 3-Year Results From the LIFE-BTK Trial.

Authors

• Sahil A Parikh
• Brian G DeRubertis
• Marc P Bonaca
• Prakash Krishnan
• Richard H Pin
• Jen-Kuang Lee
• David C Metzger
• Raghu Kolluri, OhioHealth
• Mehdi H Shishehbor
• Andrew H Holden
• Osamu Iida
• Ehrin Armstrong
• Steven W C Kum
• David J O'Connor
• Danielle R Bajakian
• Lawrence A Garcia
• Shih-Wa Ying
• Jin Wang
• Karine Ruster
• Brad J Martinsen
• Zsuzsanna Igyarto
• Ramon L Varcoe

Document Type

Article

Publication Title

Journal of the American College of Cardiology

Abstract

Background: Chronic limb-threatening ischemia (CLTI) caused by infrapopliteal disease is a major therapeutic challenge, with percutaneous transluminal angioplasty (PTA) associated with high rates of restenosis and reintervention. The LIFE-BTK trial previously demonstrated superior efficacy of the Esprit (Abbott Vascular) BTK drug-eluting resorbable scaffold (DRS) over PTA at 1 year, with sustained benefits at 2 years, with comparable safety at both time points. This report presents the 3-year outcomes.

Objectives: We aimed to compare the 3-year safety and efficacy of DRS vs PTA in patients with CLTI and infrapopliteal artery disease.

Methods: In this randomized trial, 261 patients with CLTI were assigned 2:1 to DRS or PTA. The primary efficacy endpoint was freedom from above-ankle amputation in the target limb, target vessel occlusion, clinically driven target lesion revascularization (CD-TLR), and binary restenosis of the target lesion. The primary safety endpoint was freedom from major adverse limb events and perioperative death.

Results: A total of 57% of patients completed the 3-year follow-up. By Kaplan-Meier analysis, the 3-year primary efficacy endpoint was higher with DRS than PTA (59.5% vs 44.8%; P = 0.0025), binary restenosis occurred less frequently with DRS (38.0% vs 49.0%), and CD-TLR was numerically lower with DRS (10.2% vs 18.4%). Limb salvage remained high and comparable (93.8% vs 95.7%), as did the primary safety endpoint (90.8% vs 94.2%). In multivariable Cox regression at 3 years, treatment with DRS was associated with a lower hazard of CD-TLR compared with PTA (HR: 0.46 [95% CI: 0.22-0.97]), with previous minor amputation, greater preintervention stenosis, higher residual stenosis after predilatation, and use of postprocedure dual antiplatelet therapy being independent predictors of CD-TLR. Subgroup analyses showed that outcomes generally favored DRS for patency and reintervention across most patient and lesion characteristics.

Conclusions: At 3 years, DRS demonstrated sustained advantages over PTA in preserving vessel patency, with lower restenosis and fewer reinterventions while maintaining a comparable safety profile. These findings support the use of DRS in selected patients with CLTI and infrapopliteal disease. (Pivotal Investigation of Safety and Efficacy of Drug-Eluting Resorbable Scaffold Treatment-Below the Knee [LIFE-BTK]; NCT04227899).

First Page

95

Last Page

109

DOI

10.1016/j.jacc.2026.04.008

Publication Date

7-7-2026

Recommended Citation

Parikh SA, DeRubertis BG, Bonaca MP, Krishnan P, Pin RH, Lee JK, Metzger DC, Kolluri R, Shishehbor MH, Holden AH, Iida O, Armstrong E, Kum SWC, O'Connor DJ, Bajakian DR, Garcia LA, Ying SW, Wang J, Ruster K, Martinsen BJ, Igyarto Z, Varcoe RL. Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia: 3-Year Results From the LIFE-BTK Trial. J Am Coll Cardiol. 2026 Jul 7;88(1):95-109. doi: 10.1016/j.jacc.2026.04.008. Epub 2026 May 13. PMID: 42126372.