Boston Scientific reports ‘positive’ 12-month results from AGENT IDE trial

Boston Scientific announced “positive” 12-month results from the pivotal AGENT IDE clinical trial of the AGENT Drug-Coated Balloon, or DCB. Primary endpoint findings from this first clinical trial in the U.S. to evaluate the safety and effectiveness of using a DCB to treat coronary in-stent restenosis, or ISR, were presented in a late-breaking clinical trial session at Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation, the company said. This trial met the primary endpoint of target lesion failure at 12 months with the AGENT DCB demonstrating statistical superiority to uncoated balloon angioplasty. These differences were mainly driven by significantly reduced rates of myocardial infarction related to the target vessel, TV-MI, or heart attack, and the need for a target lesion revascularization, TLR, or a repeated percutaneous coronary intervention, procedure. Overall, data demonstrated an approximate 38% relative risk reduction in TLF, the company stated.