Patients with chronic limb-threatening ischemia (CLTI) are among the most challenging in endovascular revascularization. While endovascular treatment offers a less invasive alternative to surgery, high rates of restenosis and reocclusion limit the durability of outcomes. In this context, bioresorbable scaffolds can restore patency and distal flow without leaving a permanent metallic structure, promoting more physiological vascular remodeling.
The LIFE-BTK Trial was a prospective, multicenter, randomized study designed to compare the safety and efficacy of the everolimus-eluting bioresorbable scaffold Esprit BTK (Abbott) versus conventional percutaneous transluminal angioplasty (PTA) in patients with CLTI and infrapopliteal lesions.
A total of 261 patients were randomized 2:1 (173 to Esprit BTK and 88 to PTA), with a planned five-year follow-up. Inclusion criteria featured patients with Rutherford 4 or 5, up to two de novo or post-PTA restenotic lesions, and a total lesion length ≤170 mm. Target vessel diameter had to range from 2.5 to 4.0 mm.
At three years of follow-up, the study has demonstrated a sustained clinical advantage of the Esprit BTK scaffold over conventional angioplasty, with a 33% improvement in the composite endpoint of limb salvage and primary patency (68.8% vs. 45.4% with PTA).
This difference was consistent with results at one year (74.2% vs. 47.9%) and two years (68.8% vs. 45.4%), supporting the durability of the observed benefit.
In the analysis of the primary endpoint components, there were lower binary restenosis rates (23% vs. 61%) and a 45-% reduction in clinically driven target lesion revascularizations (CD-TLR) with Esprit BTK.
The incidence of major limb events or perioperative death (MALE + POD) was low and comparable between groups, with no increase in major amputations or device-related complications.
Conclusions
The LIFE-BTK findings establish Esprit BTK as the first resorbable scaffold approved for infrapopliteal use, providing a durable therapeutic alternative for patients with CLTI requiring distal revascularization.
Presented by Sahil A. Parikh at TCT 2025 Late-Breaking Clinical Trials, October 26, San Francisco, USA.
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