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

Ramon L Varcoe; Sahil A Parikh; Brian G DeRubertis; Jennifer M Jones-McMeans; Nutte Tarn Teraphongphom; Jin Wang; Raghu Kolluri; Ido Weinberg; Andrew H Holden; Hector M Garcia-Garcia; Steven W C Kum; Marc P Bonaca; Danielle R Bajakian; Lawrence A Garcia; Prakash Krishnan; Ehrin Armstrong; Mehdi H Shishehbor; John Rundback; D Chris Metzger

doi:10.1016/j.jscai.2023.100964

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

J Soc Cardiovasc Angiogr Interv. 2023 May 19;2(4):100964. doi: 10.1016/j.jscai.2023.100964. eCollection 2023 Jul-Aug.

Authors

Ramon L Varcoe¹, Sahil A Parikh², Brian G DeRubertis³, Jennifer M Jones-McMeans⁴, Nutte Tarn Teraphongphom⁴, Jin Wang⁴, Raghu Kolluri⁵, Ido Weinberg⁶, Andrew H Holden⁷, Hector M Garcia-Garcia⁸, Steven W C Kum⁹, Marc P Bonaca¹⁰, Danielle R Bajakian², Lawrence A Garcia¹¹, Prakash Krishnan¹², Ehrin Armstrong¹³, Mehdi H Shishehbor¹⁴, John Rundback¹⁵, D Chris Metzger¹⁶

Affiliations

¹ The Prince of Wales Hospital, University of New South Wales, Randwick, New South Wales, Australia.
² Columbia University Vagelos College of Physicians and Surgeons, New York, New York.
³ NewYork-Presbyterian/Weill Cornell Medical Center, New York, New York.
⁴ Abbott Vascular, Santa Clara, California.
⁵ Syntropic Core Lab, Columbus, Ohio.
⁶ VasCore, Boston, Massachusetts.
⁷ Auckland Hospital, University of Auckland, Grafton, Auckland, New Zealand.
⁸ MedStar Washington Hospital Center, Washington, District of Columbia.
⁹ Department of Surgery, Changi General Hospital, Singapore.
¹⁰ Cardiovascular Division, CPC Clinical Research, University of Colorado School of Medicine, Aurora, Colorado.
¹¹ Vascular Care Group, Tufts University School of Medicine, Boston, Massachusetts.
¹² The Mount Sinai Hospital, New York, New York.
¹³ Advanced Heart and Vein Center, Denver, Colorado.
¹⁴ University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio.
¹⁵ Advanced Interventional and Vascular Services LLP, Teaneck, New Jersey.
¹⁶ Ballad Health, Kingsport, Tennessee.

Abstract

Background: Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients.

Methods: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years.

Conclusions: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.

Keywords: absorbable implants; angioplasty; arterial occlusive diseases; ischemia; lower extremity; peripheral arterial disease; polymers; stents.