Skip to Content

New Treatment for Coronary In-Stent Restenosis in United States

April 5, 2024

Summary of Research

BachinskyWilliam Bachinsky, MD, of UPMC Heart and Vascular Institute in Central Pa., contributed to the review and analysis of a first-of-its-kind trial in the United States that compared angioplasty outcomes between the AGENT Paclitaxel-coated balloon and an uncoated balloon. Researchers evaluated one-year target lesion failure in patients with in-stent restenosis and published their results in JAMA.

The AGENT IDE trial evaluated the efficacy of drug-coated balloon catheters for patients with coronary in-stent restenosis. Drug-coated balloons have grown in popularity due its benefits of localized drug delivery to reduce neointimal growth. An alternate option is to place additional stent layers within existing stents.

The trial enrolled 600 participants and was administered in consultation with the Food and Drug Administration. Previous European studies have showed success. The trial was funded and sponsored by Boston Scientific Corporation.

Conclusion of Findings

Participants were randomly assigned to either the paclitaxel-coated balloon or the uncoated balloon. The median age for the trial was 68. Participants in both groups had high rates of coronary artery disease and baseline lesion characteristics were also similar between both groups.

Participants were evaluated after one year for target lesion failure. Target lesion failure occurred less in the paclitaxel-coated balloon group than those with the uncoated balloon, at 17.9% and 28.6% respectively. Target lesion revascularization and target vessel myocardial infarction also occurred less frequently in the paclitaxel-coated balloon group.

In the AGENT IDE trial, Paclitaxel-coated balloons were superior to the uncoated balloons. Paclitaxel-coated balloons proved to be an effective treatment option for those with coronary in-stent restenosis.


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. Published online March 09, 2024. doi:10.1001/jama.2024.1361