Why is this study important? 

Chronic limb-threatening ischemia (CLTI) in patients with infrapopliteal disease is associated with high rates of amputation. Recent data showed that treatment using angioplasty for below-the-knee disease may be superior to surgery in select patients; however, not without limitations. Elastic recoil, dissection, and restenosis can reduce the durability of the revascularization. The LIFE-BTK trial is a single-blind, randomized, controlled trial designed to examine outcomes of using drug-eluting resorbable scaffolds in this challenging patient population. 

 What question was this study supposed to answer?  

Does the use of drug-eluting resorbable scaffolds improve outcomes in patients with infrapopliteal disease causing CLTI? 

What did the study show?  

In patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy endpoint (Freedom from amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion at 1 year).  

All authors: Luai K. Tabaza, MD, FSCAI