医学
随机对照试验
临床终点
不利影响
再狭窄
严重肢体缺血
内科学
外科
支架
血运重建
心肌梗塞
作者
Ramon L. Varcoe,Sahil A. Parikh,Brian G. DeRubertis,Jennifer Jones-McMeans,Nutte Teraphongphom,Jin Wang,Raghu Kolluri,Ido Weinberg,Andrew Holden,Hector Garcia-Garcia,Steven Kum,Marc P. Bonaca,Danielle Bajakian,Lawrence A. Garcia,Krishnan Ramanathan,Ehrin J. Armstrong,Mehdi H. Shishehbor,John H. Rundback,David C. Metzger
标识
DOI:10.1016/j.jscai.2023.100964
摘要
Abstract
Background
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. Methods
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. Conclusions
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.
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