DeRubertis Brian G, Varcoe Ramon L, Krishnan Prakash, Bonaca Marc P, O'Connor David J, Pin Richard, Metzger David C, Holden Andrew, Lee Jen-Kuang, Iida Osamu, Armstrong Ehrin J, Kum Steven W C, Kolluri Raghu, Bajakian Danielle R, Garcia Lawrence A, Shishehbor Mehdi H, Yu Shawn, Ruster Karine, Martinsen Brad J, Igyarto Zsuzsanna, Parikh Sahil A
Division of Vascular and Endovascular Surgery, New York Presbyterian-Weill Cornell Medical Center, New York, NY (B.G.D.).
The Prince of Wales Hospital and University of New South Wales, Randwick, NSW, Australia (R.L.V.).
Circulation. 2025 Oct 14;152(15):1076-1086. doi: 10.1161/CIRCULATIONAHA.125.075080. Epub 2025 Sep 10.
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.
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.
At 2 years, the primary efficacy end point was observed in 68.8% of the DRS group versus 45.4% of the PTA group (=0.0004). Limb salvage rates were 94.7% for DRS and 97.3% for PTA (=0.34). Binary restenosis occurred in 28.5% of DRS patients versus 48.2% of PTA patients (=0.005), and clinically driven target lesion revascularization rates were 9.7% versus 18.6%, respectively (=0.034). The primary safety end point was observed in 91.6% of the DRS group versus 95.6% of the PTA group (=0.16). Scaffold treatment was an independent predictor of efficacy (odds ratio, 0.27; =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.
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.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04227899.
对于慢性肢体威胁性缺血（CLTI）患者的腘动脉以下疾病，治疗选择有限，该病症与肢体丧失的高风险相关。采用经皮腔内血管成形术（PTA）对病变的腘动脉以下血管进行介入治疗，再狭窄和再次干预的发生率很高。在LIFE-BTK随机对照试验（膝下BRS治疗安全性和有效性的关键研究）中，对于主要为非复杂性、轻度至中度钙化病变的特定CLTI人群，药物洗脱可吸收支架（DRS）在12个月时显示出优于PTA的疗效。本报告展示了Esprit BTK DRS系统在LIFE-BTK随机试验中的2年安全性和有效性结果，该试验比较了DRS与PTA治疗腘动脉以下血管和CLTI的效果。
LIFE-BTK试验是一项多中心、受试者盲法、随机对照试验，纳入261例CLTI患者，以2:1的比例随机分组，分别接受DRS或PTA治疗。修订后的主要疗效终点是无目标肢体截肢、目标血管闭塞、临床驱动的目标病变血运重建或二元再狭窄。主要安全终点是无严重肢体不良事件和围手术期死亡。分析了疗效和临床驱动的目标病变血运重建的预测因素以及亚组评估。
在2年时，DRS组68.8%的患者达到主要疗效终点，而PTA组为45.4%（P = 0.0004）。DRS组的肢体挽救率为94.7%，PTA组为97.3%（P = 0.34）。DRS患者的二元再狭窄发生率为28.5%，PTA患者为48.2%（P = 0.005），临床驱动的目标病变血运重建率分别为9.7%和18.6%（P = 0.034）。DRS组91.6%的患者达到主要安全终点，PTA组为95.6%（P = 0.16）。支架治疗是疗效的独立预测因素（优势比，0.27；P = 0.0003），并且显示出临床驱动的目标病变血运重建风险降低的趋势，尽管这未达到统计学意义。其他预测因素包括病变长度、卢瑟福 - 贝克尔5级、完全闭塞、既往截肢、干预前狭窄和伤口数量。亚组分析表明在各种患者群体中疗效一致。
在2年时，与PTA相比，Esprit BTK DRS在维持动脉通畅、预防再狭窄和降低血运重建率方面显示出更好的疗效，同时保持了相当的安全性。这些发现支持Esprit BTK支架作为适合选择的腘动脉疾病和CLTI患者的一种有前景的治疗选择。
