Infra-popliteal Bioresorbable Stents: The NEJM LIFE-BTK Trial

Show notes

This episode breaks down LIFE-BTK, the 2024 New England Journal of Medicine randomized trial testing whether a drug-eluting resorbable scaffold beats plain balloon angioplasty for infrapopliteal artery disease in chronic limb-threatening ischemia.

• The Premise: Below the knee has been a graveyard of failed devices. A scaffold that resists recoil, elutes an antiproliferative drug, then dissolves promises structural support without a permanent metal cage.
• Efficacy: In 261 CLTI patients randomized 2:1, one-year freedom from the primary composite was 74% with the scaffold versus 44% with angioplasty, though the separation was driven largely by binary restenosis (76% versus 50%).
• Acute Mechanics: Core-lab technical success was 91% versus 70%, with bailout stenting needed in 6% of angioplasty cases and none in the scaffold arm.
• The Catch: Every major safety event was in the scaffold arm, including two perioperative deaths and four above-ankle amputations, three in limbs with patent scaffolds. Wound healing was numerically lower (45% versus 56%).
• Durability: As the scaffold resorbs, the benefit holds. At three years the composite endpoint remained higher for the scaffold, 59.5% versus 44.8%.
• Caveats: Only about 3% of screened patients enrolled, lesions were short and lightly calcified, vessel prep was mandatory only in the scaffold arm, and DAPT ran 12 months versus 1, all favoring the scaffold.

Tune in to learn how the first fully resorbable below-the-knee scaffold stacked up against angioplasty, and where the trial's design should temper how you apply it.

This podcast is generated using an AI model that has been trained in the context of endovascular surgery and interventional radiology in addition context of the article cited below. The content was reviewed and edited by multiple healthcare professionals in the field.

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. https://doi.org/10.1056/NEJMoa2305637