Overall, clinical procedural success rates (92.1% for DCB patients vs. 88.7% for uncoated balloon patients) and technical success rates (93.4% for DCB patients vs. 89.7% for uncoated balloon patients) were similar. Bailout stents, meanwhile, were required for three patients treated with a paclitaxel-coated balloon and one patient treated with an uncoated balloon.

Target lesion failure after 12 months was seen in 17.9% of DCB patients and 28.6% of uncoated balloon patients. This difference was primarily attributed to lower rates of ischemia-driven revascularization and target vessel myocardial infarction among patients in the DCB group.

Drug-coated balloons have emerged internationally as an alternative treatment option, but despite promising international data, they have not been previously evaluated or approved for use in the United States, lead investigator Robert W. Yeh, MD, MSc, MBA, director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology and section chief of interventional cardiology at Beth Israel Deaconess Medical Center, said in a statement. Even with advances in stent technology, patients with coronary in-stent restenosis continue to comprise approximately 10% of individuals undergoing angioplasty interventions each year. In particular, patients with multiple prior stents have very poor long-term outcomes. There's growing sentiment that drug-coated balloons could address an unmet clinical need among patients with coronary artery disease in the United States.

Click here to read the full analysis in JAMA, a journal from the American Medical Association.

When the initial positive results from AGENT IDE were presented at TCT 2023, cardiologists were thrilled that a coronary DCB could finally be on its way toward FDA approval.

Our European colleagues have had these devices for a decade, Ajay J. Kirtane, MD, an interventional cardiologist with the Columbia University Department of Medicine, said during a TCT press conference in October 2023. In the United States, we basically tell patients routinely that we can use a peripheral balloon that is too big for your coronary and try to put it in your coronary to prevent the restenosis from happening, or you can buy a ticket to London and go over there to get this treated. Its embarrassing.

American College of Cardiology President B. Hadley Wilson, MD, meanwhile, described the new analysis as a game changer.

For 25 years, weve been trying to peel back this restenosis problem, he said during the same press conference. Now we can see light at the end of the tunnel.

Boston Scientific said the Agent DCB should be available on the U.S. market in the coming months.

In addition, AGENT IDEs researchers will be tracking patient data for up to five years, so expect updates on their findings as time goes on.

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Cardiologists share historic research that led to FDA's long-awaited approval of coronary DCB - Cardiovascular Business