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Showing papers by "Ulrich Speck published in 2006"


Journal ArticleDOI
TL;DR: A randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 μg per square millimeter of balloon surface area) with those of an uncoated balloons catheter in coronary angioplasty found no significant differences.
Abstract: Background Treatment of coronary in-stent restenosis is hampered by a high incidence of recurrent in-stent restenosis. We assessed the efficacy and safety of a paclitaxel-coated balloon in this setting. Methods We enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 μg per square millimeter of balloon surface area) with those of an uncoated balloon catheter in coronary angioplasty. The primary end point was late luminal loss as seen on angiography. Secondary end points included the rates of restenosis (a binary variable) and major adverse cardiac events. Results Multivessel disease was present in 80% of patients in both groups. Quantitative coronary angiography revealed no significant differences in baseline measures. At 6 months, angiography showed that the mean (±SD) in-segment late luminal loss was 0.74±0.86 mm in the uncoated-balloon group versus 0.03±0.48 mm in the coated-balloon group (P=...

679 citations