Author Interviews, Heart Disease, Technology / 03.04.2024
Coronary In-Stent Restenosis: Paclitaxel-Coated Balloon vs Uncoated Balloon – AGENT DCB Trial Results
MedicalResearch.com Interview with:
Dr. Janarthanan Sathananthan M.D.
Chief Medical Officer for Interventional Cardiology Therapies
Boston Scientific
MedicalResearch.com: What is the background for this study?
Response: Despite significant improvements in the drug-eluting stents that are used to treat patients with coronary artery disease, 10% of the percutaneous coronary interventions (PCIs) in the U.S. today address in-stent restenosis (ISR), which is when a previously stented section of a coronary artery becomes obstructed or narrowed by plaque or scar tissue. These patients require additional intervention to avoid potential complications. In the multicenter, randomized AGENT IDE trial, we evaluated whether the AGENT™ Drug-Coated Balloon (DCB), a balloon catheter coated with anti-restenotic paclitaxel, is superior to an uncoated balloon in patients for treating ISR. The AGENT DCB is currently available in countries outside the U.S. Our goal is to bring this technology to market in the U.S. and finally provide physicians with an alternative to traditional ISR treatments, such as placing additional layers of stents or radiation, which may not provide ideal outcomes in some cases.
In October 2023, at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 meeting, we presented the primary endpoint data from our AGENT IDE randomized controlled trial evaluating clinical outcomes in patients with ISR undergoing treatment with the AGENT DCB or conventional balloon angioplasty. The positive results in this primary analysis cohort supported the device’s U.S. Food and Drug Administration (FDA) approval, which we announced on March 1, 2024. Just a few months later, data from the full cohort of 600 patients were published in the Journal of the American Medical Association (JAMA) and shared in a late-breaking presentation at Cardiovascular Research Technologies (CRT) 2024 meeting.
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Response: Despite significant improvements in the drug-eluting stents that are used to treat patients with coronary artery disease, 10% of the percutaneous coronary interventions (PCIs) in the U.S. today address in-stent restenosis (ISR), which is when a previously stented section of a coronary artery becomes obstructed or narrowed by plaque or scar tissue. These patients require additional intervention to avoid potential complications. In the multicenter, randomized AGENT IDE trial, we evaluated whether the AGENT™ Drug-Coated Balloon (DCB), a balloon catheter coated with anti-restenotic paclitaxel, is superior to an uncoated balloon in patients for treating ISR. The AGENT DCB is currently available in countries outside the U.S. Our goal is to bring this technology to market in the U.S. and finally provide physicians with an alternative to traditional ISR treatments, such as placing additional layers of stents or radiation, which may not provide ideal outcomes in some cases.
In October 2023, at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 meeting, we presented the primary endpoint data from our AGENT IDE randomized controlled trial evaluating clinical outcomes in patients with ISR undergoing treatment with the AGENT DCB or conventional balloon angioplasty. The positive results in this primary analysis cohort supported the device’s U.S. Food and Drug Administration (FDA) approval, which we announced on March 1, 2024. Just a few months later, data from the full cohort of 600 patients were published in the Journal of the American Medical Association (JAMA) and shared in a late-breaking presentation at Cardiovascular Research Technologies (CRT) 2024 meeting.
(more…)