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

Jan 04, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Trial Sponsor:
Abbott
Date Presented:
10/25/2023
Date Published:
01/04/2024
Date Updated:
01/04/2024
Original Posted Date:
10/25/2023
References

Contribution To Literature:

The LIFE-BTK trial showed that an everolimus-eluting resorbable scaffold reduces lower extremity limb events compared with balloon angioplasty.

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
  • 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 superiority).

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 noninferiority).

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

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.

References:

Highlighted text has been updated as of January 4, 2024.

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


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