Boston Scientific has announced the initiation of its AGENT DCB STANCE trial to evaluate the performance of the Agent Drug-Coated Balloon (DCB) compared with the current standard of care in treating de novo (previously untreated) coronary lesions.
The prospective, multi-center, open-label randomized controlled trial will enroll more than 1,600 patients in a 1:1 comparison against percutaneous coronary intervention (PCI) using drug-eluting stents (DES) or balloon angioplasty. The primary endpoint is target lesion failure at 12 months.
Beyond small vessel treatment, the study will also assess the use of the Agent DCB in patients with bifurcations and long lesions.
The Agent DCB, a paclitaxel-coated balloon, received FDA approval last year, becoming the first drug-coated coronary balloon available in the U.S. It provides an alternative to traditional options like angioplasty, multiple stent layers, or radiation. The device is already in commercial use in several international markets, with over 100,000 patients treated globally, and recently gained Medicare reimbursement in the U.S.
“This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Dr. Janar Sathananthan, chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “Positive results from this trial will support an expanded indication of the AGENT DCB in the U.S. and help interventional cardiologists determine the optimal treatment strategy for patients living with coronary artery disease.”