LIFE-BTK Trial Shows Durable 3-Year Benefits of Dissolving Scaffold in Below-the-Knee CLTI
核心洞察
The everolimus-eluting Esprit BTK (搜索) resorbable scaffold demonstrated a 33% relative improvement in the composite primary efficacy endpoint compared to balloon angioplasty at 3 years (59.5% vs 44.8%, P = 0.0025).
Binary restenosis rates were significantly lower with the scaffold versus angioplasty (38% vs 49%, P = 0.018), with clinically driven target lesion revascularization trending lower (10.2% vs 18.4%, P = 0.052).
The scaffold maintained comparable safety outcomes to angioplasty with no evidence of inflammatory processes or scaffold thrombosis, even as the device structure completely dissolved by 3 years.
The everolimus-eluting Esprit BTK (搜索) drug-eluting resorbable scaffold continues to demonstrate superior efficacy compared to percutaneous transluminal angioplasty (PTA) in patients with chronic limb-threatening ischemia (搜索) (CLTI (搜索)) at 3 years, even after the device structure has completely dissolved, according to results from the LIFE-BTK trial presented at VIVA 2025.
The randomized controlled trial evaluated the long-term performance of the Esprit BTK (搜索) scaffold versus PTA in patients with CLTI (搜索) and infrapopliteal artery disease (搜索). At 3 years, the scaffold demonstrated a 33% relative improvement in the composite primary efficacy endpoint of primary patency and limb salvage compared to PTA (59.5% vs 44.8%; P = 0.0025 log rank test).
Sustained Clinical Benefits Despite Device Dissolution
The 3-year data mark a significant milestone as the scaffold structure has mostly dissolved by this timepoint, with only visible remnants remaining in some patients. According to principal investigator Sahil Parikh, MD, from NewYork-Presbyterian/Columbia University Irving Medical Center (搜索), "There is little evidence that it was there. There was a little bit of concern over what happens when the structure collapses with time and the answer is nothing. It should behave like a normal artery, including with respect to reintervention."
The scaffold was associated with significantly lower rates of binary restenosis (38% vs 49%; P = 0.018 log rank test) and lower clinically driven target lesion revascularization rates, though the latter did not reach statistical significance (10.2% vs 18.4%; P = 0.052 log rank test).
Safety Profile Remains Favorable
Safety outcomes remained comparable between treatment arms throughout the 3-year follow-up period. The composite of freedom from major adverse limb events at 3 years and perioperative death at 30 days was similar between the scaffold and PTA groups (90.8% vs 94.2%; P = 0.23 log rank test). Importantly, no safety issues emerged with the dissolving scaffold, with no evidence of inflammatory processes or scaffold thrombosis.
Subgroup Analysis Reveals Treatment Optimization Opportunities
Subgroup analyses showed that the efficacy of the scaffold was consistent across most patient and lesion subgroups. However, significantly greater benefit was observed in patients with Rutherford-Becker class 4 disease and those not requiring inflow lesion treatment. Additional trends favoring the scaffold emerged in patients with none/mild calcification, mixed wound etiology, 'Other' race, and in those treated outside the United States.
These findings suggest potential for personalized treatment strategies based on baseline clinical and anatomical characteristics, according to the investigators.
Study Design and Patient Population
The LIFE-BTK trial enrolled 261 patients (mean age 72.6 years; 32% female) with Rutherford class 4 or 5 CLTI (搜索) and infrapopliteal artery stenosis or occlusion. The protocol mandated that all lesions be located in separate arteries in the proximal two-thirds of the infrapopliteal space and have runoff to the ankle free of clinically significant disease.
The mean treated lesion length was 43.7 mm in the scaffold group and 44.7 mm in the angioplasty group, with a total scaffold length per patient of 170 mm or less. Most patients had mild/no calcification, with more than one-quarter in both arms having moderate calcification.
Implications for Clinical Practice
Discussant Eric Secemsky, MD, from Beth Israel Deaconess Medical Center, described LIFE-BTK as "revolutionary" for below-the-knee interventions. Having data suggesting a greater than 50% chance that patients will be alive with a patent vessel and without needing an amputation at 3 years "completely changes how we train our fellows and how we take care of this disease pathology," he said.
The scaffold provides tangible hope for patients that the device can help them avoid repeat peripheral procedures, which is especially important for younger, working patients who need to stay out of the hospital and maintain their employment.
Future Directions
The 3-year mark signifies the end of protocol-mandated imaging follow-up for LIFE-BTK patients, but clinical follow-up will continue for surviving patients at years 4 and 5. A postapproval study at 50 US sites has almost completed enrollment to evaluate real-world outcomes and pathophysiologic changes.
The investigators expect to see longer lesions and greater degrees of calcification in the real-world population than were allowed in the trial, which will require more intense lesion preparation. As Parikh noted, "That's going to be important because we don't really have a good sense of how lesion preparation factors into this yet."
The Esprit BTK (搜索) scaffold, which consists of a bioresorbable poly-L lactide backbone with thin struts and everolimus coating, was approved by the US Food and Drug Administration (搜索) in 2024 and received CE Mark in 2025. It remains the only completely dissolvable therapy for peripheral interventions.