Drug-Eluting Resorbable Scaffold Versus Balloon Angioplasty for Below-the-Knee Peripheral Artery Disease: 2-Year Results From the LIFE-BTK Trial

Abstract

BACKGROUND: Limited treatment options exist for infrapopliteal disease in patients with chronic limb-threatening ischemia (CLTI), a condition associated with a high risk of limb loss. Interventional management of diseased infrapopliteal vessels with percutaneous transluminal angioplasty (PTA) is associated with high rates of restenosis and reintervention. In the LIFE-BTK randomized controlled trial (Pivotal Investigation of Safety and Efficacy of BRS Treatment-Below the Knee), the drug-eluting resorbable scaffold (DRS) demonstrated superior 12-month efficacy compared with PTA in a selected CLTI population with predominantly noncomplex, mildly to moderately calcified lesions. This report presents the 2-year safety and efficacy outcomes of the Esprit BTK DRS system in the LIFE-BTK randomized trial comparing DRS with PTA for treatment of infrapopliteal vessels and CLTI. METHODS: The LIFE-BTK trial was a multicenter, subject-blinded, randomized controlled trial enrolling 261 patients with CLTI who were randomized 2:1 to receive either DRS or PTA. The revised primary efficacy end point was freedom from target limb amputation, target vessel occlusion, clinically driven target lesion revascularization, or binary restenosis. The primary safety end point was freedom from major adverse limb events and perioperative death. Predictors of efficacy and clinically driven target lesion revascularization were analyzed along with subgroup assessments. RESULTS: At 2 years, the primary efficacy end point was observed in 68.8% of the DRS group versus 45.4% of the PTA group ( P =0.0004). Limb salvage rates were 94.7% for DRS and 97.3% for PTA ( P =0.34). Binary restenosis occurred in 28.5% of DRS patients versus 48.2% of PTA patients ( P =0.005), and clinically driven target lesion revascularization rates were 9.7% versus 18.6%, respectively ( P =0.034). The primary safety end point was observed in 91.6% of the DRS group versus 95.6% of the PTA group ( P =0.16). Scaffold treatment was an independent predictor of efficacy (odds ratio, 0.27; P =0.0003) and showed a trend toward reduced risk of clinically driven target lesion revascularization, though this did not reach statistical significance. Other predictors included lesion length, Rutherford-Becker class 5, total occlusion, previous amputation, preintervention stenosis, and number of wounds. Subgroup analyses demonstrated consistent efficacy across various patient populations. CONCLUSIONS: At 2 years, the Esprit BTK DRS demonstrated improved efficacy compared with PTA in maintaining arterial patency, preventing restenosis, and reducing revascularization rates while maintaining a comparable safety profile. These findings support the Esprit BTK scaffold as a promising treatment option for appropriately selected patients with infrapopliteal artery disease and CLTI. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04227899.