Data from Boston Scientific‘s (NYSE:BSX) Ranger SFA trial showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty.
The results, which were published this month in JACC: Cardiovascular Interventions, demonstrated that both groups of patients – those treated with Boston Scientific’s Ranger DCB and those treated with standard balloon angioplasty – experienced similar quality-of-life improvements over the course of 12 months.
The 105-patient trial enrolled people with symptomatic lower limb ischemia, a lesion that measured between 20mm and 150mm in length and stenotic lesions in the nonstented superficial femoral artery or proximal popliteal segment, according to a report from Healio.
After one year, patients in the DCB group had a 86% primary patency rate compared to a 56.5% rate in the balloon angioplasty group. Freedom from target lesion revascularization was 91.2% in the DCB group and 69.9% in the balloon angioplasty group.
The researchers also noted that there were no device-related deaths or target limb amputations over the course of the trial.
“The study adds to the available information on peripheral treatment with drug-coated balloons, providing clinical evidence unique to the Ranger drug-coated balloon,” Dr. Sabine Steiner, of the University of Leipzig in Germany, wrote.
In an editorial, Dr. Konstantinos Katsanos of the Patras University Hospital School of Medicine called on researchers to compare paclitaxel-coated balloons directly in head-to-head trials.