Drug-coated balloons an effective tool in the battle against femoropopliteal disease
Paclitaxel drug-coated balloons (DCBs) are an effective treatment option for the treatment of femoropopliteal artery disease and femoropopliteal in-stent restenosis, according to two late-breaking clinical trials presented at the VIVA Foundation’s VIVA22 conference in Las Vegas.
Both studies focused on Medtronic’s IN.PACT Admiral DCBs. The first late-breaking clinical trial was presented by interventional cardiologist Mehdi Shishehbor, DO, MPH, PhD, president of the Harrington Heart and Vascular Institute in Cleveland, Ohio, on Nov. 1.
Shishehbor et al. performed a pooled analysis of four different multicenter studies, comparing the effectiveness of DCBs and bare metal stents (BMS) when treating femoropopliteal artery disease. A total of 771 patients were included in the analysis, including 288 who were treated with a DCB. Overall, the DCB group was linked to stronger twelve-month primary patency than the BMS group (90.4% vs. 80.9%) and improved freedom from clinically driven target lesion revascularization (TLR) after three years (85.6% vs. 73.7%). Major adverse events after three years were also less common among patients treated with a DCB (25.3%) than those treated with a BMS (38.8%). All-cause mortality after three years was comparable between the two treatment options.
The team’s full analysis was simultaneously published in the Journal of the American College of Cardiology.[1]
The second late-breaking clinical trial focused on Medtronic’s IN.PACT Admiral DCBs was presented by Daniel J. Bertges, MD, a vascular surgeon with the University of Vermont Medical Center in Burlington, Vermont, on Nov. 2.
Bertges et al. performed a registry-based study using data from 300 patients who were treated at one of 43 different care sites across the United States. All patients were treated with an IN.PACT Admiral DCB for femoropopliteal in-stent restenosis. The mean patient age was 68 years old, and 58% were male.
Overall, the researchers found that freedom from TLR was seen in 89.8% of patients after 12 months and 72% of patients after 24 months. Freedom from major target limb amputation was 99.6% after 12 months and 98.8% after 24 months. Freedom from all-cause mortality, meanwhile, was 95.3% after 12 months and 89.3% after 24 months.
Medtronic’s perspective
John Laird, MD, chief medical officer of Medtronic’s peripheral vascular health business, highlighted the results from these two VIVA22 late-breaking clinical trials in a prepared statement.
“Medtronic is deeply committed to gathering ongoing clinical evidence to evaluate product performance,” he said. “The findings from these studies, each of which evaluated the IN.PACT Admiral DCB, further support the use paclitaxel-coated balloons in the treatment of femoropopliteal disease.”
VIVA22 in Las Vegas
The presentation by Shishehbor occurred during the first round of late-breaking clinical trials at VIVA22. More information on the other presentations that took place during that first round is available here.
The presentation by Bertges occurred during the third and final round of late-breaking clinical trials at VIVA22. More information on the other presentations that took place during that round is available here.
Additional details about VIVA22 are available on the VIVA Foundation’s website.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.