Sex-Stratified Outcomes of Drug-Eluting Resorbable Scaffolds Versus Balloon Angioplasty for Below-the-Knee Revascularization: Insights From the LIFE-BTK Trial

Abstract

Background

Women with chronic limb-threatening ischemia remain historically underrepresented in peripheral artery disease trials and often exhibit distinct anatomic and clinical profiles. The LIFE-BTK randomized trial demonstrated superiority of an everolimus-eluting resorbable scaffold (DRS) over percutaneous transluminal angioplasty (PTA) for below-the-knee revascularization. This analysis assessed whether sex influenced baseline characteristics, procedural details, or clinical outcomes after DRS compared with PTA.

Methods

LIFE-BTK randomly assigned 261 patients (2:1 DRS/PTA) with Rutherford-Becker class 4-5 ischemia across 50 global sites. Sex-stratified outcomes at 1 and 2 years were evaluated using descriptive statistics, multivariate models, and Kaplan–Meier estimates. The primary efficacy end point was freedom from above-ankle amputation, target vessel occlusion, clinically-driven target lesion revascularization (CD-TLR), and binary restenosis. The primary safety end point was freedom from major adverse limb events and perioperative death. Both end points are presented here as event rates.

Results

Female patients (32% of cohort) were older and had smaller reference vessel diameters and lower ankle-brachial index values; male patients had higher tobacco use and cardiovascular comorbidities. At 1 year, DRS significantly reduced event rates for the primary efficacy end point vs PTA in both sexes (female: 23.5% vs 57.1%; male: 26.5% vs 56.0%). Benefits persisted at 2 years (female: 34.1% vs 68.4%; male: 40.7% vs 66.7%). Binary restenosis and CD-TLR were lower with DRS. Multivariate analysis showed sex was not significantly associated with outcomes, and no sex-by-treatment interaction was observed. Female patients demonstrated higher restenosis but lower CD-TLR rates, suggesting discordance between anatomic and clinical failure.

Conclusions

DRS provided durable benefit over PTA irrespective of sex. Although sex did not modify treatment effect, differences in vessel size, ischemia severity, and restenosis–reintervention patterns highlight the need for sex-specific surveillance and personalized below-the-knee treatment strategies.