Twenty-Four-Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease

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; IVUS‐DCB investigators

doi: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.

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Twenty-Four-Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease

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 ; IVUS‐DCB investigators

Citation: JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol.14(16) : e041564, 2025-08

Journal Title: JOURNAL OF THE AMERICAN HEART ASSOCIATION

Issue Date: 2025-08

MeSH: 0

Keywords: Aged ; Amputation, Surgical ; Angiography ; Angioplasty, Balloon* / adverse effects ; Angioplasty, Balloon* / instrumentation ; Angioplasty, Balloon* / methods ; Coated Materials, Biocompatible* ; Female ; Femoral Artery* / diagnostic imaging ; Femoral Artery* / physiopathology ; Follow-Up Studies ; Humans ; Limb Salvage ; Male ; Middle Aged ; Peripheral Arterial Disease* / diagnostic imaging ; Peripheral Arterial Disease* / physiopathology ; Peripheral Arterial Disease* / therapy ; Popliteal Artery* / diagnostic imaging ; Popliteal Artery* / physiopathology ; Time Factors ; Treatment Outcome ; Ultrasonography, Interventional* ; Vascular Access Devices* ; Vascular Patency

Abstract: drug‐coated balloon ; femoropopliteal artery disease ; imaging‐guided angioplasty ; intravascular ultrasound ; peripheral artery disease

Article Number: 10.1161/JAHA.125.041564

DOI: 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.

Appears in Collections:: 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

Yonsei Authors: Ko, Young Guk(고영국) https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) https://orcid.org/0000-0003-2493-066X
Ahn, Chul-Min(안철민) https://orcid.org/0000-0002-7071-4370
Lee, Sanghyup(이상협)
Lee, Seung-Jun(이승준) https://orcid.org/0000-0002-9201-4818
Im, Eui(임의) https://orcid.org/0000-0002-5333-7593
Jang, Yang Soo(장양수) https://orcid.org/0000-0002-2169-3112
Choi, Dong Hoon(최동훈) https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) https://orcid.org/0000-0002-2090-2031

URI: https://ir.ymlib.yonsei.ac.kr/handle/22282913/207529

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