At this year’s annual EuroPCR meeting, Boston Scientific (NYSE:BSX touted results from the first trial to compare two drug-coated balloons with different drug formulations – Boston Scientific’s Agent paclitaxel-coated PTCA device and B. Braun’s SeQuent Please balloon.
The 125-patient study evaluated the balloons in patients with in-stent restenosis of a lesion previously treated with a drug-eluting stent or drug-coated balloon.
“Treatment with Agent DCB was expected to be non-inferior to treatment with SeQuent Please DCB when comparing in-stent late lumen loss 6 months post-procedure as measured by QCA,” principal investigator Dr. Holger Nef of the University of Giessen in Germany told Drug Delivery Business News.
The trial also included secondary clinical, angiographic and quality-of-life endpoints. The two drug-coated balloons differ in drug formulation, Nef noted.
“The core of Agent DCB technology is a proprietary drug and excipient formulation applied to the balloon component of an approved, state-of-the-art conventional PTCA balloon catheter, with a highly effective drug/excipient coating formulation allowing for a reduced drug dose density of 2 ug/mm2 paclitaxel,” he said.
“In preclinical investigations, this coating composition has been shown to be comparably effective to 3 ug/mm2 formulations of other DCB platforms while reducing systemic drug exposure,” Nef added.
One-year data from the trial found that the Agent DCB was non-inferior to the Sequent Please DCB for in-stent late lumen loss at six months. While researchers observed decreases in revascularization and stent thrombosis rates in the Agent DCB group, the difference between the two arms did not reach significance, according to Nef.
The team plans to follow this patient group for up to three years.
Updated 5/30 to reflect that researchers observed decreases – not increases, as previously reported – in revascularization and stent thrombosis rates in the Agent DCB group.