A paclitaxel-coated balloon demonstrated significantly higher primary patency rates at 12 months and lower odds of reintervention when compared to uncoated balloon angioplasty for femoropopliteal lesions, according to the first randomized, one-year study of the device.
More specifically, the Ranger balloon (Boston Scientific) showed a patency rate of 86.4 percent while a conventional balloon had a rate of 56.5 percent. More than 90 percent of patients in the Ranger group avoided revascularization of the target lesion within one year, while 30 percent of patients in the control group required reintervention.
Sabine Steiner, MD, MSc, with the University of Leipzig in Germany, and colleagues published these findings in JACC: Cardiovascular Interventions after randomizing 105 patients 2:1 to treatment with the Ranger or a conventional balloon, respectively. Baseline characteristics were similar between groups.
“The 12-month efficacy results of the RANGER SFA study substantiate the 6-month late lumen loss findings, with greater patency rates and fewer reinterventions for patients treated with Ranger DCB compared with patients receiving conventional balloon angioplasty,” they wrote. “Similar symptomatic, hemodynamic, walking function, and health-related quality-of-life improvements were observed for both study groups, but this was achieved with about one-third fewer reinterventions for patients treated with the Ranger DCB.”
The authors pointed out it’s difficult to directly compare the results of this study to those of other DCBs because of differences in the devices and the patients they treated. However, they noted the Ranger would rank on the “high end” of all DCBs studied in terms of primary patency and in the middle of the pack in terms of preventing reinterventions.
“In the previous studies, reinterventions were performed between about 1.4 and seven times less often for patients treated with a DCB versus conventional balloon angioplasty, with the ILLUMENATE European study (also of a paclitaxel-coated balloon) reporting a difference similar to that observed in RANGER SFA of about three times fewer TLRs (target lesion revascularizations),” noted Steiner et al., whose study was funded by Boston Scientific.
Since several DCBs have shown the potential to improve femoropoliteal interventions versus conventional balloon angioplasty, the researchers said the next step is to design comparative studies evaluating these newer devices against one another.
Writing in a related editorial, Konstantinos Katsanos, MD, PhD, with Patras University Hospital in Greece, said, “Undoubtedly, paclitaxel-coated balloons have emerged as the new standard of care for femoropopliteal lesions of low to intermediate complexity in patients experiencing short distance claudication.”
Even so, Katsanos questioned their usefulness in more complex lesions, considering the study by Steiner et al. didn’t include any patients with critical limb ischemia (CLI) and previous analyses only included 15 to 20 percent of patients with CLI. Also, he said the lack of benefit in the symptomatic, hemodynamic and quality-of-life metrics would likely blunt the cost-effectiveness of the Ranger DCB, even if it led to fewer repeat operations.
“Many more questions remain to be addressed, with burning needs in the field of critical limb ischemia and person-centered clinical outcomes,” Katsanos wrote.
Mary joined TriMed Media in 2003. She was the founding editor and editorial director of Health Imaging, Cardiovascular Business, Molecular Imaging Insight and CMIO, now known as Clinical Innovation + Technology. Prior to TriMed, Mary was the editorial director of HealthTech Publishing Company, where she had worked since 1991. While there, she oversaw four magazines and related online media, and piloted the launch of two magazines and websites. Mary holds a master’s in journalism from Syracuse University. She lives in East Greenwich, R.I., and when not working, she is usually running around after her family, taking photos or cooking.