Journal of the American College of Cardiology · 2026
Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia: 3-Year Results From the LIFE-BTK Trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Parikh Sahil A, DeRubertis Brian G, Bonaca Marc P, Krishnan Prakash, Pin Richard H, Lee Jen-Kuang, Metzger David C, Kolluri Raghu, Shishehbor Mehdi H, Holden Andrew H, Iida Osamu, Armstrong Ehrin, Kum Steven W C, O'Connor David J, Bajakian Danielle R, Garcia Lawrence A, Ying Shih-Wa, Wang Jin, Ruster Karine, Martinsen Brad J, Igyarto Zsuzsanna, Varcoe Ramon L
Аннотация
BACKGROUND: Chronic limb-threatening ischemia (CLTI) caused by infrapopliteal disease is a major therapeutic challenge, with percutaneous transluminal angioplasty (PTA) associated with high rates of restenosis and reintervention. The LIFE-BTK trial previously demonstrated superior efficacy of the Esprit (Abbott Vascular) BTK drug-eluting resorbable scaffold (DRS) over PTA at 1 year, with sustained benefits at 2 years, with comparable safety at both time points. This report presents the 3-year outcomes.
OBJECTIVES: We aimed to compare the 3-year safety and efficacy of DRS vs PTA in patients with CLTI and infrapopliteal artery disease.
METHODS: In this randomized trial, 261 patients with CLTI were assigned 2:1 to DRS or PTA. The primary efficacy endpoint was freedom from above-ankle amputation in the target limb, target vessel occlusion, clinically driven target lesion revascularization (CD-TLR), and binary restenosis of the target lesion. The primary safety endpoint was freedom from major adverse limb events and perioperative death.
RESULTS: A total of 57% of patients completed the 3-year follow-up. By Kaplan-Meier analysis, the 3-year primary efficacy endpoint was higher with DRS than PTA (59.5% vs 44.8%; P = 0.0025), binary restenosis occurred less frequently with DRS (38.0% vs 49.0%), and CD-TLR was numerically lower with DRS (10.2% vs 18.4%). Limb salvage remained high and comparable (93.8% vs 95.7%), as did the primary safety endpoint (90.8% vs 94.2%). In multivariable Cox regression at 3 years, treatment with DRS was associated with a lower hazard of CD-TLR compared with PTA (HR: 0.46 [95% CI: 0.22-0.97]), with previous minor amputation, greater preintervention stenosis, higher residual stenosis after predilatation, and use of postprocedure dual antiplatelet therapy being independent predictors of CD-TLR. Subgroup analyses showed that outcomes generally favored DRS for patency and reintervention across most patient and lesion characteristics.
CONCLUSIONS: At 3 years, DRS demonstrated sustained advantages over PTA in preserving vessel patency, with lower restenosis and fewer reinterventions while maintaining a comparable safety profile. These findings support the use of DRS in selected patients with CLTI and infrapopliteal disease. (Pivotal Investigation of Safety and Efficacy of Drug-Eluting Resorbable Scaffold Treatment-Below the Knee [LIFE-BTK]; NCT04227899).
OBJECTIVES: We aimed to compare the 3-year safety and efficacy of DRS vs PTA in patients with CLTI and infrapopliteal artery disease.
METHODS: In this randomized trial, 261 patients with CLTI were assigned 2:1 to DRS or PTA. The primary efficacy endpoint was freedom from above-ankle amputation in the target limb, target vessel occlusion, clinically driven target lesion revascularization (CD-TLR), and binary restenosis of the target lesion. The primary safety endpoint was freedom from major adverse limb events and perioperative death.
RESULTS: A total of 57% of patients completed the 3-year follow-up. By Kaplan-Meier analysis, the 3-year primary efficacy endpoint was higher with DRS than PTA (59.5% vs 44.8%; P = 0.0025), binary restenosis occurred less frequently with DRS (38.0% vs 49.0%), and CD-TLR was numerically lower with DRS (10.2% vs 18.4%). Limb salvage remained high and comparable (93.8% vs 95.7%), as did the primary safety endpoint (90.8% vs 94.2%). In multivariable Cox regression at 3 years, treatment with DRS was associated with a lower hazard of CD-TLR compared with PTA (HR: 0.46 [95% CI: 0.22-0.97]), with previous minor amputation, greater preintervention stenosis, higher residual stenosis after predilatation, and use of postprocedure dual antiplatelet therapy being independent predictors of CD-TLR. Subgroup analyses showed that outcomes generally favored DRS for patency and reintervention across most patient and lesion characteristics.
CONCLUSIONS: At 3 years, DRS demonstrated sustained advantages over PTA in preserving vessel patency, with lower restenosis and fewer reinterventions while maintaining a comparable safety profile. These findings support the use of DRS in selected patients with CLTI and infrapopliteal disease. (Pivotal Investigation of Safety and Efficacy of Drug-Eluting Resorbable Scaffold Treatment-Below the Knee [LIFE-BTK]; NCT04227899).