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Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized

Ramon L Varcoe1, Sahil A Parikh2, Brian G DeRubertis3

  • 1The Prince of Wales Hospital, University of New South Wales, Randwick, New South Wales, Australia.

Journal of the Society for Cardiovascular Angiography & Interventions
|August 12, 2024
PubMed

Insights

The Esprit BTK scaffold shows promise for treating critical limb ischemia below the knee. This randomized controlled trial evaluates its safety and efficacy compared to standard angioplasty for peripheral artery disease patients.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Biomaterials Science

Background:

  • Critical limb-threatening ischemia (CLTI) affects 5-10% of peripheral artery disease patients, with limited FDA-approved below-the-knee (BTK) devices.
  • Existing BTK treatments face high restenosis rates due to intimal hyperplasia, elastic recoil, and dissection, highlighting a need for improved scaffolding.
  • The Esprit BTK system, a resorbable, drug-eluting scaffold, aims to address these limitations in infrapopliteal atherosclerosis.

Purpose of the Study:

  • To evaluate the safety and efficacy of the Esprit BTK drug-eluting resorbable scaffold.
  • To compare the Esprit BTK scaffold against percutaneous transluminal angioplasty in patients with CLTI.
  • To assess the potential of novel scaffold devices in improving outcomes for challenging vascular conditions.

Main Methods:

  • The LIFE-BTK randomized controlled trial (RCT) enrolled 261 subjects with CLTI.
  • The primary efficacy endpoint was a composite of limb salvage and primary patency at 12 months.
  • Primary safety endpoints included freedom from major adverse limb events (6 months) and peri-operative death (30 days), with 5-year follow-up planned.

Main Results:

  • The study is a prospective premarket evaluation of the Esprit BTK scaffold.
  • Results will determine the scaffold's effectiveness in limb salvage and maintaining artery patency.
  • Safety data will be collected on major adverse limb events and peri-operative mortality.

Conclusions:

  • Randomized controlled trials are crucial for evaluating novel devices like the Esprit BTK scaffold.
  • Testing against the standard of care is essential for improving outcomes in CLTI patients.
  • The LIFE-BTK trial will provide vital data on the safety and efficacy of resorbable scaffolds for BTK interventions.
Abstract

Keywords:
absorbable implantsangioplastyarterial occlusive diseasesischemialower extremityperipheral arterial diseasepolymersstents

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