Intravascular Ultrasound-Guided vs Angiography-Guided Drug-Coated Balloon Angioplasty in Patients With Complex Femoropopliteal Artery Disease.

Abstract

Background: Intravascular ultrasound (IVUS) guidance has been shown to yield favorable outcomes for endovascular treatment of femoropopliteal artery (FPA) disease with drug-coated balloon (DCB) angioplasty. However, the specific benefits of IVUS for treatment of complex FPA lesions remain uncertain.

Objectives: In this study, the authors compared the clinical impact of IVUS-guided vs angiography-guided DCB angioplasty in patients with complex or noncomplex FPA lesions.

Methods: This study was a prespecified, primary subgroup analysis of the randomized IVUS-DCB trial. Patients with FPA undergoing DCB angioplasty were randomized to receive the procedure under IVUS or angiography guidance. The primary endpoint was 12-month primary patency; secondary endpoints included clinically driven target lesion revascularization (CD-TLR), sustained clinical improvement, and hemodynamic improvement.

Results: Among the 237 patients enrolled, 158 had complex FPA (Trans-Atlantic Inter-Society Consensus II [TASC II] type C/D), and 79 had noncomplex FPA (TASC II type A/B). In complex FPA, IVUS guidance was associated with significantly higher rates of primary patency (82.1% vs 60.3%; HR for loss of primary patency: 0.34; 95% CI: 0.16-0.70; P = 0.002), freedom from CD-TLR (90.0% vs 76.9%; HR: 0.31; 95% CI: 0.13-0.75; P = 0.01), and sustained clinical and hemodynamic improvement relative to angiography guidance. There was no significant difference in primary patency (87.5% vs 88.2%; HR: 1.84; 95% CI: 0.39-8.60; P = 0.44) or occurrence secondary endpoints between the IVUS-guidance and angiography-guidance groups for patients with noncomplex FPA.

Conclusions: In endovascular treatment of FPA using DCB, IVUS guidance was significantly associated with improved 12-month clinical outcomes, particularly in patients with complex FPA lesions.(Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease [IVUS-DCB] trial; NCT03517904).