One-year success rates from angioplasty to treat femoropopliteal artery disease were significantly higher among patients whose procedures were guided by IVUS alongside angiography compared with those whose procedures were guided by angiography alone, according to results from the IVUS-DCB study presented during a Late-Breaking Clinical Trial session at ACC.24 in Atlanta.

Researchers at seven sites in South Korea randomized 237 patients undergoing angioplasty for symptomatic femoropopliteal artery disease to guidance with IVUS plus angiography (n=119) or angiography (n=118). The patients were 70 years old, mostly men (85%) and 15% had prior peripheral revascularization. About half of patients had TASC II lesion type A to C and half had type D. The lesion length was 204.9 mm and 214.5 mm in the IVUS and angiography groups respectively.

The results, presented by Young Guk-Ko, MD, showed technical and procedural success were higher in the IVUS group (76.5% and 73.9%) compared with the angiography group (61.0% and 60.2%). Post-procedure ankle-brachial index was 0.99 and 0.93 in the two respective groups (p=0.001).

At one year, the primary outcome of primary patency was achieved in 83.8% of patients in the IVUS group and 70.1% of patients in the angiography group (hazard ratio [HR], 0.46; 95% CI, 0.25-0.85; log-rank p=0.01). Looking at primary patency by TASC II lesion type, IVUS performed better than angiography for TASC A/B (HR, 0.62; log-rank p=0.52) and TASC C/D (HR, 0.33; log-rank p=0.002).

Patients who received IVUS were also significantly less likely to require target-lesion revascularization and significantly more likely to show sustained clinical improvement compared with the angiography group.

"The IVUS group utilized larger pre-dilation balloon diameters and higher pressures prior to drug-coated balloon application as well as more frequent post-dilation and higher pressures for post-dilation after drug-coated balloon application, compared to the angiography group," Ko said. "These optimizations, based on IVUS assessments, may have led to an increased final lumen diameter and better maintenance of the patent target vessel at the 12-month follow-up."

The researchers noted that most of the femoropopliteal artery lesions treated in the study were complex and extensive and it is unclear whether the benefits of IVUS would be the same for treating shorter and less severe lesions. In addition, they said the study only applies to procedures involving drug-coated balloons in femoropopliteal arteries, and further research would be needed to clarify possible benefits of IVUS with other types of devices, such as stents, and in other peripheral arteries.

"IVUS is more accurate than angiography in measuring vessel dimensions. It facilitates achieving sufficient vessel lumen diameters and aids in evaluating the response of the target lesion to treatment," said Ko. "Despite the potential increase in procedural complexity, IVUS may benefit patients by enhancing treatment outcomes."