03 Apr Coronary In-Stent Restenosis: Paclitaxel-Coated Balloon vs Uncoated Balloon – AGENT DCB Trial Results
MedicalResearch.com Interview with:
Dr. Sathananthan
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.
MedicalResearch.com: What are the main findings?
The main findings from the AGENT IDE trial are:
- The AGENT DCB was statistically superior to conventional (uncoated) balloon angioplasty for the primary endpoint of target lesion failure at 12 months(9% versus 28.6%, P=0.003). This reflected at 41% relative risk reduction with the AGENT DCB.
- These differences were driven by approximately 50% reductions in the rates of target lesion revascularization (13.0% vs. 24.7%, P=0.0005) and myocardial infarction related to the target vessel (5.8% vs. 11.1%, P=0.023) following treatment with the AGENT DCB compared to uncoated balloon angioplasty.
- At 12 months, the AGENT DCB also demonstrated statistically lower adverse event rates. Notably, no cases of definite or probable stent thrombosis occurred in the AGENT DCB arm (0.0% vs. 3.2%; P=0.0004).
MedicalResearch.com: What should readers take away from your report? Are there additional complications with the coated balloon?
Response: An important differentiator between the AGENT DCB and uncoated balloons is that the AGENT DCB transfers a consistent, therapeutic dose of the anti-restenotic drug to the artery wall via a proprietary technology to help prevent ISR reoccurrence, and without leaving behind another layer of permanent metal implants.
In the AGENT IDE trial, patients treated with the AGENT DCB had a lower rate of target lesion failure, which, according to the study, attributed to a “lower rate of ischemia-driven revascularization and target vessel myocardial infarction, compared with patients treated with an uncoated balloon.”
Patients with multiple prior stents at the target legion are at a significantly higher risk for recurrent restenosis. In this trial, more than 40% of patients with ISR were in this category. In this group, rates of 1-year target lesion failure were nearly twice as common compared to patients who previously had only a single layer of stent in the target lesion. However, data in this high-risk group with multilayer ISR demonstrated that treatment with the AGENT DCB resulted in a consistent relative risk reduction in the rate of 1-year target lesion failure than uncoated balloon angioplasty.
Also notable is that the study results indicated there were no occurrences of definite or probable stent thrombosis at 1 year in the AGENT DCB group, whereas six patients in the uncoated balloon group experienced this outcome.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: The AGENT IDE trial definitively demonstrated the safety and efficacy of the AGENT DCB, signaling that it is an important new treatment option for patients with coronary artery disease who develop ISR. Given uptake of the device in other parts of the world, we expect U.S. providers to strongly consider adopting the AGENT DCB.
We look forward to the results of a sub-group analysis of patients in the AGENT IDE trial with multi-layer ISR, which will be presented at the American College of Cardiology 2024 meeting by Study Chair Dr. Ajay Kirtane. We are also exploring post-approval study options for the AGENT DCB.
MedicalResearch.com: Is there anything else you would like to add?
Response: As reported in JAMA, the AGENT IDE trial is the first trial of coronary DCB conducted in the U.S. and the largest randomized clinical trial to date examining the efficacy and safety of a DCB in patients with coronary ISR. In addition to now being approved in the U.S., the device is already commercially available in many international markets and has been used to treat more than 100,000 patients globally over several years. We are excited about the opportunity to introduce this proven, effective treatment alternative to U.S. physicians and their patients.
Disclosures: Dr. Sathananthan is employed by Boston Scientific.
Citations:
1)Yeh RW, Shlofmitz R, Moses J, et al. Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. 2024;331(12):1015–1024. doi:10.1001/jama.2024.1361
https://jamanetwork.com/journals/jama/fullarticle/2816073
2) Positive results from the new data set (n=600) are very similar to those from the prespecified analysis (n=480) presented at TCT 2023
The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition.
Some links may be sponsored. Products are not endorsed.
Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.
Last Updated on April 3, 2024 by Marie Benz MD FAAD