Varcoe Ramon L, Parikh Sahil A, DeRubertis Brian G, Jones-McMeans Jennifer M, Teraphongphom Nutte Tarn, Wang Jin, Kolluri Raghu, Weinberg Ido, Holden Andrew H, Garcia-Garcia Hector M, Kum Steven W C, Bonaca Marc P, Bajakian Danielle R, Garcia Lawrence A, Krishnan Prakash, Armstrong Ehrin, Shishehbor Mehdi H, Rundback John, Metzger D Chris
The Prince of Wales Hospital, University of New South Wales, Randwick, New South Wales, Australia.
Columbia University Vagelos College of Physicians and Surgeons, New York, New York.
J Soc Cardiovasc Angiogr Interv. 2023 May 19;2(4):100964. doi: 10.1016/j.jscai.2023.100964. eCollection 2023 Jul-Aug.
Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients.
The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years.
Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.
严重肢体缺血（CLTI）是一种严重病症，其特征为静息痛和缺血性组织损失，影响5%至10%的外周动脉疾病患者。在美国，美国食品药品监督管理局（FDA）批准用于膝下动脉（BTK）初级治疗的器械很少。不幸的是，由于内膜增生、弹性回缩以及因缺乏支架而未治疗的夹层，所有这些器械都存在较高的再狭窄率。Esprit BTK系统是一种可吸收的药物洗脱支架装置，有潜力满足因腘下动脉粥样硬化而患CLTI患者的未满足需求。LIFE-BTK（药物洗脱可吸收支架治疗膝下动脉安全性和有效性的关键性研究）随机对照试验（RCT）是一项前瞻性设计的上市前评估，用于评估Esprit BTK药物洗脱可吸收支架在这些患者治疗中的应用。
LIFE-BTK试验纳入261名CLTI受试者进行RCT，并另外纳入7名受试者进行药代动力学子研究。RCT的目的是评估Esprit BTK支架与经皮腔内血管成形术相比的安全性和有效性。主要疗效终点是12个月时保肢和原发性通畅的复合指标。主要安全终点分别是6个月和30天时无严重肢体不良事件和围手术期死亡。计划进行5年的临床随访。
如果我们要改善这类具有挑战性的患者群体的治疗效果，新器械必须在RCT中进行测试，以评估其与标准治疗相比的安全性和有效性。
