Researchers compared the efficacy and safety of a drug-coated balloon versus an uncoated balloon in a study published in the Journal of the American Medical Association to treat in-stent restenosis, a complication that affects up to 10% of patients undergoing percutaneous coronary intervention (PCI) with modern drug-eluting stents.

The trial involved 600 patients randomised into two groups, with two-thirds receiving a paclitaxel-coated balloon and the remainder receiving an uncoated balloon during PCI. Baseline characteristics were similar between groups, with an average age of 68 years, 26% of participants being women, and 43% having multiple-layer in-stent restenosis.

The main outcome, which included ischemia-driven target-lesion revascularisation, target-vessel myocardial infarction, or cardiac death at 12 months, was much lower in the drug-coated balloon group (18% vs. 29%) than in the uncoated balloon group. The drug-coated balloon significantly reduced both target-lesion revascularization (13% vs. 25%) and target-vessel myocardial infarction (6% vs. 11%).

These findings were consistent across various subgroups, indicating broad applicability. Importantly, there was no apparent increase in the risk of stent thrombosis with the use of the drug-coated balloon.

Overall, the study shows that using a drug-coated balloon to treat in-stent restenosis may have better results than using regular uncoated balloons. This could mean that patients don't need as many interventions and have better safety and prognosis.