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In-stent restenosis occurs in up to 10% of patients undergoing percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. In this multicenter, randomized trial, investigators assessed the efficacy and safety of a drug-coated balloon versus an uncoated balloon for treatment of in-stent restenosis.
Six hundred patients were randomized 2:1 to receive a paclitaxel-coated balloon or an uncoated balloon during PCI. Baseline characteristics were similar between groups; mean age was 68 years, 26% of participants were women, and 43% of patients had multiple-layer in-stent restenosis.
The incidence of the primary composite endpoint — ischemia-driven target-lesion revascularization, target-vessel myocardial infarction, or cardiac de…