TOPLINE:

In patients with multilayer in-stent restenosis (ISR), treatment with a paclitaxel-coated balloon reduced target lesion failure (TLF) at 1 year to 23.8% compared with 40% with an uncoated balloon. The approach showed consistent benefits in patients with multilayer and single-layer ISR, with a greater absolute reduction in risk among multilayer cases.

METHODOLOGY:

A total of 600 patients with ISR were randomized in a 2:1 ratio to receive either a paclitaxel-coated or uncoated balloon treatment at 40 clinical sites in the US.

Participants had ISR with a reference vessel diameter between 2 mm and 4 mm, and lesion length < 26 mm, with target stenosis > 50% for symptomatic or > 70% for asymptomatic cases before predilation.

Randomization was stratified by multilayer vs single-laye

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