Boston Scientific (NYSE:BSX) announced today that it initiated a new trial to assess its Agent DCB compared to the standard of care.
The AGENT DCB STANCE trial pits the drug-coated balloon (DCB) head-to-head against percutaneous coronary intervention (PCI) treatment with drug-eluting stents (DES) and/or balloon angioplasty – in patients with de novo (previously untreated) coronary lesions.
Boston Scientific’s prospective, multi-center, open-label, 1:1 randomized controlled study includes more than 1,600 patients. It has a primary endpoint defined as target lesion failure at 12 months.
In addition to evaluating de novo small vessel treatment with Agent DCB, the trial also examines the use of the device in patients with bifurcations and long lesions.
Boston Scientific won FDA approval for Agent last year, making it the first drug-coated coronary balloon available in the U.S. The paclitaxel-coated balloon serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation.
The company also offers Agent commercially in several international markets, with more than 100,000 patients treated with Agent globally. It picked up a Medicare win for the DCB earlier this month.
