by Elana Gotkine

A paclitaxel-coated balloon is superior to an uncoated balloon for the composite end point of target lesion failure among patients undergoing coronary angioplasty for in-stent restenosis, according to a study published online March 9 in the Journal of the American Medical Association to coincide with Cardiovascular Research Technologies 2024, held from March 9 to 12 in Washington, D.C.

Robert W. Yeh, M.D., from the Beth Israel Deaconess Medical Center in Boston, and colleagues examined whether a paclitaxel-coated balloon is superior to an uncoated balloon in 600 patients with in-stent restenosis undergoing percutaneous coronary intervention at 40 centers. Participants were randomly assigned to undergo treatment with a paclitaxel-coated or uncoated balloon (406 and 194 patients, respectively).

The researchers found that the primary end point of one-year target lesion failure occurred in 17.9 and 28.6 percent of patients in the paclitaxel-coated and uncoated balloon groups, respectively, meeting the criteria for superiority (hazard ratio, 0.59). Patients treated with paclitaxel-coated balloon less often had target lesion revascularization and target vessel-related myocardial infarction (hazard ratios, 0.50 and 0.51, respectively). In the coated versus uncoated balloon groups, the rate of cardiac death was not significantly different (2.9 versus 1.6 percent).

"Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis," the authors write.

More information: Robert W. Yeh et al, Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis, JAMA (2024). DOI: 10.1001/jama.2024.1361

Amartya Kundu et al, Drug-Coated Balloons for In-Stent Restenosis—Finally Leaving Nothing Behind for US Patients, JAMA (2024). DOI: 10.1001/jama.2024.0813

Journal information: Journal of the American Medical Association 

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