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

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).