Pivotal Investigation of Safety and Efficacy of Drug-Eluting Resorbable Scaffold Treatment-Below the Knee - LIFE-BTK

Oct 26, 2025
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Fred M. Kusumoto, MD, FACC
Trial Sponsor:
Abbott
Date Presented:
10/26/2025
Date Published:
01/04/2024
Date Updated:
10/26/2025
Original Posted Date:
10/25/2023
References

Highlighted text has been updated as of Oct. 26, 2025.

Contribution To Literature:

The LIFE-BTK trial showed that an everolimus-eluting resorbable scaffold reduces lower extremity limb events compared with balloon angioplasty. Results were sustained at 3 years.

Description:

The goal of the trial was to evaluate the use of an everolimus-eluting resorbable scaffold compared with balloon angioplasty among patients with chronic limb-threatening ischemia and infrapopliteal artery disease.

Study Design

  • Randomized
  • Parallel
  • Blinded

Patients with chronic limb-threatening ischemia and infrapopliteal artery disease were randomized to an everolimus-eluting resorbable scaffold (n = 173) vs. balloon angioplasty (n = 88).

  • Total number of enrollees: 261
  • Duration of follow-up: 1 year; 3 years
  • Mean patient age:72 years
  • Percentage female: 32%
  • Percentage with diabetes: 70%

Inclusion criteria:

  • Patients ≥18 years of age with chronic limb-threatening ischemia and infrapopliteal artery disease
  • Chronic limb-threatening ischemia defined as Rutherford-Becker class 4 or 5

Principal Findings:

The primary efficacy outcome, freedom from amputation above the ankle, occlusion of the target vessel, clinically driven revascularization of the target lesion, or binary restenosis of the target lesion at 1 year, was: 74% in the everolimus-eluting resorbable scaffold group vs. 44% in the angioplasty group (p < 0.0001="" for="" />

The primary safety outcome, freedom from major adverse limb events at 6 months, occurred in 97% of the everolimus-eluting resorbable scaffold group vs. 100% of the angioplasty group (p < 0.0001="" for="" />

Secondary outcomes:

  • Freedom from amputation above ankle of target limb, occlusion of target vessel, or clinically driven revascularization of target lesion at 1 year: 83% with everolimus-eluting resorbable scaffold group vs. 70% with angioplasty

Three-year follow-up:

The primary efficacy outcome was 59.5% in the everolimus-eluting resorbable scaffold group and 44.8% in the angioplasty group (p=0.025). The safety profile for the everolimus group was maintained at 3 years compared with angioplasty. The between-group difference for clinically driven target lesion revascularization remained substantial, with a 45% reduction in the everolimus group vs. angioplasty.

Interpretation:

Among patients with chronic limb-threatening ischemia, an everolimus-eluting resorbable scaffold reduces lower extremity limb outcomes compared with balloon angioplasty. Safety outcomes were similar between treatment groups. An everolimus-eluting resorbable scaffold may represent a novel strategy for chronic limb-threatening ischemia due to infrapopliteal artery disease.

Results at 3 years demonstrated that the everolimus scaffold provides sustained clinical advantage over angioplasty, with a 33% relative improvement for the composite endpoint of limb salvage and primary patency, driven by lower rates of binary restenosis and clinically driven target lesion revascularization. The researchers note that these findings support the everolimus-eluting resorbable scaffold as a durable and effective endovascular treatment option for this patient population, offering long-term vessel preservation and reducing the need for reintervention.

References:

Presented by Dr. Sahil A. Parikh at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2025), San Francisco, CA, Oct. 26, 2025.

Varcoe RL, DeRubertis BG, Kolluri R, et al. Drug-Eluting Resorbable Scaffold Versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med 2024;390:9-19.

Editorial: Beckman JA. Coming of Age for Device Therapy in Peripheral Artery Disease. N Engl J Med 2024;390:78-79.

Presented by Dr. Ramon L. Varcoe at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 25, 2023.

Clinical Topics: Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Invasive Cardiovascular Angiography and Intervention

Keywords: Peripheral Arterial Disease, Peripheral Intervention, TCT23, Transcatheter Cardiovascular Therapeutics, TCT25


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