Core Concepts
Boston Scientific's Agent Drug-Coated Balloon (DCB) receives FDA approval for treating coronary in-stent restenosis, showing superior outcomes compared to conventional treatments.
Abstract
The US FDA approved Boston Scientific's Agent Drug-Coated Balloon (DCB) for treating coronary in-stent restenosis. The DCB transfers a therapeutic dose of paclitaxel to the vessel wall to prevent restenosis. Results from the AGENT IDE trial showed significant benefits over conventional treatments, with reduced target lesion failure, stent thrombosis, and myocardial infarction rates. The DCB is deemed effective and safe, offering a new treatment option for a challenging condition.
Stats
In-stent restenosis accounts for about 10% of percutaneous coronary interventions in the US.
The Agent DCB showed a 38% relative risk reduction and a 10% absolute risk reduction in target lesion failure compared to uncoated balloon angioplasty.
The Agent DCB demonstrated zero definite/probable cases of stent thrombosis and a 49% risk reduction in target-vessel related myocardial infarction.
Quotes
"This represented a 38% relative risk reduction as well as a 10% absolute risk reduction in the endpoint." - Robert Yeh, MD