Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month results from the pivotal AGENT IDE clinical trial of the AGENT™ Drug-Coated Balloon (DCB).1 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 (ISR) were presented in a late-breaking clinical trial session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

While coronary stenting is commonly used to restore blood flow to the heart in patients with coronary artery disease, ISR – a condition in which the stented section of the artery becomes obstructed or narrowed by plaque or scar tissue – still occurs in some cases and is addressed in 10% of U.S. percutaneous coronary interventions.2,3 The AGENT DCB is a paclitaxel-coated balloon catheter designed to re-open these vessels and then transfer the therapeutic drug to the vessel wall to help prevent ISR reoccurrence.

This trial met the primary endpoint of target lesion failure4 (TLF) at 12 months with the AGENT DCB demonstrating statistical superiority to uncoated balloon angioplasty (17.9% vs. 28.7%; P=0.006). 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, and additional 12-month event rates for the AGENT DCB vs. uncoated balloon included:

• Zero definite/probable cases of clotting within the stent, known as stent thrombosis (0.0% vs. 3.9%, P=0.001)
• 51% risk reduction in TLR (12.4% vs. 24.0%, P=0.002)
• 49% risk reduction in TV-MI (6.4% vs. 12.3%, P=0.03)