Paclitaxel-coated balloon works well in patients with coronary in-stent stenosis

For patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon significantly lowers the incidence of target lesion failure compared with an uncoated balloon, according to the results of the multicentre AGENT IDE trial.

AGENT IDE included 600 patients (mean age 68 years, 26.2 percent women, 7 percent Black) with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) enrolled from 40 centres across the US. These patients were randomly assigned to undergo treatment with a paclitaxel-coated (n=406) or an uncoated (n=194) balloon.

The majority of patients (95.7 percent) completed the 1-year follow-up. During this period, the primary endpoint of 1-year target lesion failure occurred with less frequency in the paclitaxel-coated group than in the uncoated group (17.9 percent vs 28.6 percent), establishing paclitaxel-coated balloon’s superiority (hazard ratio [HR], 0.59, 95 percent confidence interval [CI], 0.42–0.84; p=0.003). Target lesion failure was defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death.

Furthermore, the paclitaxel-coated group had lower rates of target lesion revascularization (13.0 percent vs 24.7 percent; HR, 0.50, 95 percent CI, 0.34–0.74; p=0.001) and target vessel–related myocardial infarction (5.8 percent vs 11.1 percent; HR, 0.51, 95 percent CI, 0.28–0.92; p=0.02) compared with the uncoated group.

There was no significant between-group difference in the rate of cardiac death (2.9 percent vs 1.6 percent; HR, 1.75, 95 percent CI, 0.49–6.28; p=0.38).

The findings indicate that paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis.