Findings Presented From RCT of IVUS-Guided DCB Angioplasty for PAD

April 8, 2024—One-year results from the IVUS-DCB randomized controlled trial demonstrated the clinical benefits of using intravascular ultrasound (IVUS) in angioplasty procedures with drug-coated balloons (DCBs) to treat peripheral artery disease. The study focused on femoral artery disease that was causing pain while walking.

Young-Guk Ko, MD, the study’s lead author, presented the findings in a late-breaking clinical trials session at ACC.24, the American College of Cardiology’s Annual Scientific Session held April 6-8 in Atlanta, Georgia. Dr. Ko is a cardiologist in the Division of Cardiology at Severance Hospital and Yonsei University in Seoul, South Korea.

According to the ACC press release, the study found that success rates from angioplasty procedures to open clogged arteries in the legs were significantly higher in patients whose procedures were guided by IVUS with angiography compared with those whose procedures were guided by angiography alone.

“IVUS is more accurate than angiography in measuring vessel dimensions,” commented Dr. Ko in the ACC’s press release. “It facilitates achieving sufficient vessel lumen diameters and aids in evaluating the response of the target lesion to treatment. Despite the potential increase in procedural complexity, IVUS may benefit patients by enhancing treatment outcomes.”

As summarized in the ACC press release, the trial investigators enrolled 237 patients undergoing angioplasty for femoropopliteal disease at seven sites in South Korea. Half of those patients were randomly assigned to receive IVUS plus angiography and half received angiography alone.

At 12 months, primary patency was achieved in 83.8% of patients who received IVUS and 70.1% of those receiving angiography alone. Patients who received IVUS were also significantly less likely to require revascularization procedures and significantly more likely to show sustained clinical improvement compared with the angiography group.

The investigators noted that because IVUS is more accurate than angiography in measuring vessel dimension, the use of IVUS appears to have helped operators achieve a wider opening in the blood vessel for longer-lasting results.

“The IVUS group utilized larger predilation balloon diameters and higher pressures prior to DCB application as well as more frequent postdilation and higher pressures for postdilation after DCB application compared to the angiography group,” commented Dr. Ko in the press release. “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.”

According to the ACC press release, one caveat is that most of the femoropopliteal artery lesions treated in the study were complex and extensive (> 20-cm length on average), and it is unclear whether the benefits of IVUS would be the same for treating shorter and less severe lesions.

In addition, the investigators stated that the study only applies to procedures involving DCBs in femoropopliteal arteries. Further research would be needed to clarify possible benefits of IVUS with other types of devices, such as stents, and in other peripheral arteries.

The study was funded by Medtronic and Korea United Pharm. Inc.