1. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.
- Author
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Varcoe RL, DeRubertis BG, Kolluri R, Krishnan P, Metzger DC, Bonaca MP, Shishehbor MH, Holden AH, Bajakian DR, Garcia LA, Kum SWC, Rundback J, Armstrong E, Lee JK, Khatib Y, Weinberg I, Garcia-Garcia HM, Ruster K, Teraphongphom NT, Zheng Y, Wang J, Jones-McMeans JM, and Parikh SA
- Subjects
- Humans, Absorbable Implants, Angioplasty, Balloon adverse effects, Angioplasty, Balloon methods, Chronic Disease, Everolimus administration & dosage, Everolimus adverse effects, Everolimus therapeutic use, Immunosuppressive Agents administration & dosage, Immunosuppressive Agents adverse effects, Immunosuppressive Agents therapeutic use, Ischemia drug therapy, Ischemia etiology, Ischemia surgery, Tissue Scaffolds, Treatment Outcome, Angioplasty adverse effects, Angioplasty methods, Blood Vessel Prosthesis Implantation methods, Chronic Limb-Threatening Ischemia etiology, Chronic Limb-Threatening Ischemia surgery, Drug-Eluting Stents, Peripheral Arterial Disease complications, Peripheral Arterial Disease drug therapy, Peripheral Arterial Disease surgery, Popliteal Artery surgery
- Abstract
Background: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown., Methods: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: 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. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death., Results: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group., Conclusions: Among 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 end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.)., (Copyright © 2023 Massachusetts Medical Society.)
- Published
- 2024
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