Twenty‐Four–Month Outcomes of Intravascular Ultrasound‐Guided Drug‐Coated Balloon Angioplasty for Femoropopliteal Artery Disease
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Background The IVUS‐DCB (Intravascular Ultrasound‐Guided Drug‐Coated Balloon Angioplasty for Femoropopliteal Artery Disease) trial found that intravascular ultrasound (IVUS)–guided drug‐coated balloon (DCB) angioplasty was associated with superior 12‐month outcomes, compared with conventional angiography‐guided DCB angioplasty. However, the durability of these benefits remains uncertain. The aim of this study was to compare the 24‐month outcomes of IVUS‐guided versus angiography‐guided DCB angioplasty for femoropopliteal artery disease. Methods This extended study analyzed a total of 237 patients who were previously randomized into IVUS‐guidance (n=119) or angiography‐guidance (n=118) groups in the original IVUS‐DCB trial. The 24‐month clinical efficacy outcomes included freedom from clinically driven target lesion revascularization, sustained clinical and hemodynamic improvements, and freedom from major amputation. Results At 24‐month follow‐up, the IVUS‐guidance group exhibited significantly higher rates of freedom from clinically driven target lesion revascularization (87.4% versus 78.0%; hazard ratio, 0.46 [95% CI, 0.24–0.88]; P =0.02), sustained clinical improvement (82.4% versus 71.2%, P =0.02), and sustained hemodynamic improvement (74.8% versus 61.0%, P =0.01), compared with the angiography‐guidance group. No major amputations occurred in either group during the 24‐month follow‐up. There were no significant differences in safety outcomes between groups, including all‐cause death, cardiovascular death, and major bleeding. Conclusions At 24‐month follow‐up, IVUS‐guided DCB angioplasty for femoropopliteal artery disease continued to demonstrate superior outcomes, compared with angiography‐guided DCB angioplasty, in terms of freedom from clinically driven target lesion revascularization, sustained clinical improvement, and sustained hemodynamic improvement.
Authors: Jonghu Shin, Chul‐Min Ahn, Seung‐Jun Lee, Sang‐Hyup Lee, Yong‐Joon Lee, Byeong‐Keuk Kim, Myeong‐Ki Hong, Yangsoo Jang, Tae‐Hoon Kim, Ha‐Wook Park, Ji Yong Jang, Jae‐Hwan Lee, Jae‐Hyeong Park, Su Hong Kim, Eui Im, Sang‐ho Park, Donghoon Choi, Young‐Guk Ko, the IVUS‐DCB investigators
Institutions: Yonsei University, Severance Hospital, Hanil General Hospital, Sejong General Hospital, National Health Insurance Service Ilsan Hospital, Chungnam National University Hospital, Chungnam National University Sejong Hospital, Yongin Severance Hospital, Soonchunhyang University, Soonchunhyang University Hospital Cheonan
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,810
OpenAlex ID: W4413107613