Journal of the American Heart Association · 2025
Twenty-Four-Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Shin Jonghu, Ahn Chul-Min, Lee Seung-Jun, Lee Sang-Hyup, Lee Yong-Joon, Kim Byeong-Keuk, Hong Myeong-Ki, Jang Yangsoo, Kim Tae-Hoon, Park Ha-Wook, Jang Ji Yong, Lee Jae-Hwan, Park Jae-Hyeong, Kim Su Hong, Im Eui, Park Sang-Ho, Choi Donghoon, Ko Young-Guk, IVUS‐DCB investigators
Аннотация
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.
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.