Holden Andrew, Varcoe Ramon, DeRubertis Brian, Garcia-Garcia Hector M, Khatib Yazan, Metzger Chris, Krishnan Prakash, Cawich Ian, Kum Steven, Popiel Anette, Rapoza Richard, Jones-McMeans Jennifer M, Parikh Sahil
Department of Interventional Radiology, Auckland City Hospital, University of Auckland, Auckland, New Zealand.
Prince of Wales Hospital, University of New South Wales, Randwick, NSW, Australia.
J Endovasc Ther. 2025 Dec 15:15266028251399144. doi: 10.1177/15266028251399144.
As the most severe manifestation of peripheral arterial disease, patients with chronic limb-threatening ischemia (CLTI) are at significant risk for adverse outcomes, such as amputation and mortality. A standard endovascular therapy for below the knee (BTK) intervention, percutaneous transluminal angioplasty (PTA), has shown high rates of restenosis and frequent re-interventions. Alternative technologies, such as drug-eluting stents (DES) and drug-coated balloons, have not consistently demonstrated superiority over PTA and have not received US regulatory approval. Esprit BTK, recently approved by the Food and Drug Administration (FDA), is a novel drug-eluting resorbable scaffold (DRS) designed for treatment of infrapopliteal artery disease in patients with CLTI. The Esprit BTK DRS has shown superior efficacy and non-inferior safety compared with PTA. This technology is an evolution of the coronary Absorb bioresorbable vascular scaffold (BVS) sought to improve upon the limitations of metallic DES. Coronary use of Absorb BVS provided both technical and clinical insights that informed the design and adaptation of bioresorbable scaffolds for infrapopliteal applications. Findings from the ABSORB coronary clinical trials and Absorb BTK studies for treating infrapopliteal atherosclerotic disease, including procedural and implantation best practices, were incorporated and implemented into the development of the Esprit BTK DRS and LIFE-BTK randomized controlled trial protocol.Clinical ImpactThe Esprit BTK drug-eluting resorbable scaffold is the first Food and Drug Administration (FDA)-approved bioresorbable device for infrapopliteal artery disease in patients with chronic limb-threatening ischemia (CLTI). In the LIFE-BTK randomized trial, it demonstrated superior efficacy and non-inferior safety versus angioplasty. Designed with thinner struts and optimized for BTK anatomy, Esprit BTK incorporates learnings from Absorb bioresorbable vascular scaffold and emphasizes intravascular imaging and procedural best practices. These innovations address clinical challenges, offering clinicians a novel, evidence-based alternative to percutaneous transluminal angioplasty with the potential to improve long-term outcomes in patients with CLTI.
作为外周动脉疾病最严重的表现形式，慢性肢体威胁性缺血（CLTI）患者面临截肢和死亡等不良后果的重大风险。经皮腔内血管成形术（PTA）作为一种用于膝下（BTK）干预的标准血管内治疗方法，已显示出较高的再狭窄率和频繁的再次干预率。药物洗脱支架（DES）和药物涂层球囊等替代技术并未始终如一地证明其优于PTA，且未获得美国监管部门的批准。最近获得美国食品药品监督管理局（FDA）批准的Esprit BTK是一种新型药物洗脱可吸收支架（DRS），专为治疗CLTI患者的腘下动脉疾病而设计。与PTA相比，Esprit BTK DRS已显示出卓越的疗效和非劣效的安全性。这项技术是冠状动脉Absorb生物可吸收血管支架（BVS）的演变，旨在改进金属DES的局限性。冠状动脉使用Absorb BVS提供了技术和临床见解，为腘下应用的生物可吸收支架的设计和调整提供了参考。ABSORB冠状动脉临床试验和用于治疗腘下动脉粥样硬化疾病的Absorb BTK研究的结果，包括手术和植入的最佳实践，被纳入并应用于Esprit BTK DRS的开发和LIFE - BTK随机对照试验方案中。临床影响Esprit BTK药物洗脱可吸收支架是首个获得美国食品药品监督管理局（FDA）批准的用于慢性肢体威胁性缺血（CLTI）患者腘下动脉疾病的生物可吸收装置。在LIFE - BTK随机试验中，它与血管成形术相比显示出卓越的疗效和非劣效的安全性。Esprit BTK采用更细的支架设计，并针对BTK解剖结构进行了优化，融合了从Absorb生物可吸收血管支架中学到的经验，并强调血管内成像和手术最佳实践。这些创新解决了临床挑战，为临床医生提供了一种基于证据的新型替代方案，以替代经皮腔内血管成形术，有可能改善CLTI患者的长期预后。
