Treatment of Femoropopliteal Lesions with Drug-Coated Balloons: IVUS vs. Conventional Angiography

Angiography has traditionally been the standard imaging technique to guide endovascular therapy (EVT) in patients with peripheral arterial disease. However, its capacity is limited to showing 2D images of the vascular lumen, without providing any information on complete vessel structure. This hinders the precise choice of device, balloon, or stent size, as well as the adequate assessment of procedural outcomes.

Intravascular ultrasound (IVUS) provides detailed information on vascular dimensions and plaque characteristics. Its use has been shown to improve clinical outcomes in the treatment of complex coronary lesions and, in recent years, it has also been expanded to the management of peripheral arterial disease. However, clinical evidence supporting the use of IVUS compared with standard angiography in peripheral artery interventions remains limited.

The aim of this prospective, multicenter, randomized study was to compare the outcomes of IVUS versus conventional angiography in the treatment of femoropopliteal lesions, considering different levels of complexity.

The primary endpoint (PEP) was target-lesion primary patency, defined as the absence of clinically driven target-lesion revascularization (CD-TLR) or restenosis at 12 months. The secondary endpoint (SEP) included the incidence of CD-TLR, as well as clinical and hemodynamic improvement parameters.

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A total of 237 patients were included in the IVUS-DCB study and treated with drug-coated balloon angioplasty for femoropopliteal lesions. Of these subjects, 158 had complex lesions (TASC II type C/D) and 79 had non-complex lesions (TASC II type A/B).

In the group with complex lesions, the use of IVUS was associated with significantly higher rates of primary patency (82.1% vs. 60.3%; hazard ratio [HR]: 0.34; 95% confidence interval [CI]: 0.16–0.70; p = 0.002), lower incidence of 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 compared with angiographic guidance.

In the group with non-complex lesions, there were no significant differences in either primary patency (87.5% vs. 88.2%; HR: 1.84; 95% CI: 0.39–8.60; p = 0.44) or secondary endpoints between patients guided by IVUS and those guided by angiography.

Conclusion

The use of IVUS in drug-coated balloon angioplasty was associated with higher rates of primary patency and clinical improvement in complex femoropopliteal lesions, without significant differences in cases of non-complex lesions compared with angiographic guidance.

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

Reference: Seung-Jun Lee, MD et al JACC Cardiovasc Interv. 2025;18:558–569.