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

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.