Boston Scientific launches study comparing drug-coated balloons to standard care
Boston Scientific said it has initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the AGENT drug-coated balloon compared to the standard of care using either percutaneous coronary intervention (PCI) with drug-eluting stents and/or balloon angioplasty. The trial will enroll more than 1,600 patients and is expected to reach its primary completion date in 2028.
The study will include patients with previously untreated coronary lesions and will randomize them in a prospective, multicenter, open-label, 1-to-1 controlled global study. The primary endpoint is defined as target lesion failure at 12 months. The trial is also notable for specifically examining the use of drug-eluting balloons in bifurcation lesions and long lesions.
“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 Janar Sathananthan, MD, 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.”
The AGENT DCB is the only drug-coated coronary balloon approved for use in the U.S. and is currently indicated to treat coronary in-stent restenosis. Boston Scientific said clinical data from the pivotal AGENT IDE trial, which supported U.S. Food and Drug Administration clearance in February 2024, showed the AGENT DCB was statistically superior to conventional uncoated angioplasty balloons for the primary endpoint of target lesion failure at 12 months. The company hopes the new trial will demonstrate similarly superior efficacy over stents and plain balloon angioplasty in PCI.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]