Article Impact Level: HIGH Data Quality: STRONG Summary of JAMA, 331(12), 1015. https://doi.org/10.1001/jama.2024.1361 Dr. Robert W. Yeh et al.
Points
- The AGENT IDE trial evaluated the efficacy of a paclitaxel-coated balloon compared to an uncoated balloon for 1-year target lesion failure in patients with in-stent restenosis undergoing percutaneous coronary intervention.
- Target lesion failure was significantly lower in the paclitaxel-coated balloon group (17.9%) compared with the uncoated balloon group (28.6%), indicating the superiority of the paclitaxel-coated balloon in reducing adverse outcomes.
- Ischemia-driven target lesion revascularization and target vessel myocardial infarction occurred less frequently after treatment with a paclitaxel-coated balloon, further supporting its effectiveness in managing coronary in-stent restenosis.
- The study, conducted at 40 centers across the United States and involving 600 patients, demonstrated that paclitaxel-coated balloons offer a beneficial treatment strategy for patients with in-stent restenosis undergoing coronary angioplasty.
- Overall, the findings from the AGENT IDE trial provide strong evidence for the superiority of paclitaxel-coated balloons over uncoated balloons in reducing adverse cardiovascular events and target lesion failure in patients with coronary in-stent restenosis.
Summary
In a multicenter randomized trial involving 600 patients with in-stent restenosis, the efficacy of a paclitaxel-coated balloon compared to an uncoated balloon for 1-year target lesion failure in patients undergoing percutaneous coronary intervention was evaluated. The study found that target lesion failure was significantly lower in the paclitaxel-coated balloon group (17.9%) compared with the uncoated balloon group (28.6%) (P = .003). Additionally, ischemia-driven target lesion revascularization and target vessel myocardial infarction occurred less frequently after treatment with a paclitaxel-coated balloon. The primary endpoint of 1-year target lesion failure, defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death, was met with superiority in the paclitaxel-coated balloon group.
The AGENT IDE trial, conducted at 40 centers across the United States, enrolled 600 patients with in-stent restenosis and completed a one-year clinical follow-up. The primary endpoint at one year occurred in 17.9% of the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority. Target lesion revascularization and target vessel-related myocardial infarction occurred less frequently among patients treated with a paclitaxel-coated balloon. The study concluded that among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon concerning the composite endpoint of target lesion failure, thus offering an effective treatment option for patients with coronary in-stent restenosis.
In summary, the findings from the AGENT IDE trial provide evidence that treatment with a paclitaxel-coated balloon offers an effective treatment strategy for the management of coronary in-stent restenosis, demonstrating superiority over uncoated balloons in reducing target lesion failure, ischemia-driven target lesion revascularization, and target vessel-related myocardial infarction.
Link to the article: https://jamanetwork.com/journals/jama/fullarticle/2816073
References Yeh, R. W., Shlofmitz, R., Moses, J., Bachinsky, W., Dohad, S., Rudick, S., Stoler, R., Jefferson, B. K., Nicholson, W., Altman, J., Bateman, C., Krishnaswamy, A., Grantham, J. A., Zidar, F. J., Marso, S. P., Tremmel, J. A., Grines, C., Ahmed, M. I., Latib, A., … Patel, R. (2024). Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA, 331(12), 1015. https://doi.org/10.1001/jama.2024.1361
