Drug-Eluting Resorbable Scaffold for Infrapopliteal Artery Disease

To the Editor: In their article on the LIFE-BTK trial, Varcoe et al. (Jan. 4 issue)(1) compare treatment with a drug-eluting scaffold with angioplasty in patients with infrapopliteal artery disease and chronic limb-threatening ischemia. Some aspects of this trial raise questions. The primary safety end point, freedom from major adverse limb events at 6 months and from perioperative death, has some overlap with the composite primary efficacy end point, freedom from amputation above the ankle of the target limb, total occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion at . . .