Randomized clinical trial to compare the efficacy of self-expanding bare metal nitinol stent and balloon angioplasty alone for below-the-knee lesions following successful balloon angioplasty: 1-year clinical outcomes

• Published in: PloS one Vol. 18; no. 11; p. e0294132
• Main Authors: Ahn, Jihun, Yu, HyeYon, Rha, Seung-Woon, Choi, Byoung Geol, Kang, Dong Oh, Choi, Cheol Ung, Park, Sangho, Seo, Jon, Kim, Kichang, Kim, Minung, Kim, Yong Hoon, Seo, Yong Seong
• Format: Journal Article
• Language: English
• Published: San Francisco Public Library of Science 13.11.2023; Public Library of Science (PLoS)
• Subjects: Amputation; Angioplasty; Balloon treatment; Biology and Life Sciences; Clinical outcomes; Clinical trials; Clopidogrel; Heart; Implants; Intermetallic compounds; Ischemia; Knee; Lesions; Medicine and Health Sciences; Myocardial infarction; Nickel alloys; Nickel titanides; Patient outcomes; Patients; Stent (Surgery); Stents; Transluminal angioplasty; South Korea; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0294132

This prospective, multicenter, randomized study aimed to compare the 1-year clinical outcomes after primary stenting with self-expanding bare metal nitinol stent (SENS) and plain old balloon angioplasty (POBA) in patients with critical limb ischemia (CLI) and below-the-knee (BTK) lesions. Overall, 119 patients with CLI and BTK lesions were randomized to POBA alone (POBA group, 61 patients) or primary stenting with SENS (stenting group, 58 patients) after achieving acceptable POBA results in target BTK lesions. Clinical outcomes including amputation and revascularization rates were prospectively compared for 1 year. After 1 year, similar incidence rates of individual clinical endpoints, including cardiac death (6.5% vs. 5.1%, p > 0.999), myocardial infarction (1.6% vs. 0.0%, p > 0.999), repeat revascularization (19.6% vs. 18.9%, p = 0.922), target lesion revascularization (13.1% vs. 17.2%, p = 0.530), and amputation (4.9% vs. 0.0%, p = 0.244), were observed. POBA appeared to have acceptable treatment outcomes compared with primary stenting with SENS after 1 year in CLI patients with BTK lesions undergoing percutaneous transluminal angioplasty (PTA).