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Randomized Controlled Trial
. 2023 Nov 13;18(11):e0294132.
doi: 10.1371/journal.pone.0294132. eCollection 2023.

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

Jihun Ahn  1 , HyeYon Yu  2 , Seung-Woon Rha  3 , Byoung Geol Choi  3 , Dong Oh Kang  3 , Cheol Ung Choi  3 , Sangho Park  4 , Jon Seo  5 , Kichang Kim  6 , Minung Kim  7 , Yong Hoon Kim  8 , Yong Seong Seo  9
Affiliations
Randomized Controlled Trial

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

Jihun Ahn et al. PLoS One. .

Abstract

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).

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow chart.
Fig 2
Fig 2. The cumulative incidence of target extremity amputation and revascularization up to 1-year by Kaplan-Meier analysis.
See this image and copyright information in PMC

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