Authors: Martin Unverdorben Franz X Kleber Hubertus Heuer HansReiner Figulla Christian Vallbracht Matthias Leschke Bodo Cremers Stefan Hardt Michael Buerke Hanns Ackermann Michael Boxberger Ralf Degenhardt Bruno Scheller
Publish Date: 2010/01/06
Volume: 99, Issue: 3, Pages: 165-174
Abstract
Onehundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxelcoated balloon 3 μg/mm2 The main inclusion criteria encompassed diameter stenosis of ≥70 and ≤22 mm in length with a vessel diameter of 225–28 mm Followup angiography was performed at scheduled 6month postintervention or whenever driven by clinical or electrocardiographic signs of ischemia The primary endpoint was angiographic insegment late lumen lossEightytwo of 118 patients 70 with a vessel diameter of 235 ± 019 mm were treated with the drugcoated balloon only while 32 patients required additional stent deployment The mean insegment late lumen loss was 028 ± 053 mm In patients treated with the drugcoated balloon only the insegment late lumen loss was 016 ± 038 mm At 12 months the rate of major adverse cardiac events was 15 which was primarily due to the need for target lesion revascularization in 14 patients 12 In those with additional bare metal stent implantation geographical mismatch between coatedballoon dilatation and stent implantation was significantly associated with the occurrence of restenosisThe study was supported by B Braun Melsungen Germany Dr Unverdorben receives salaries from the Institut für Klinische Forschung Herz und Kreislaufzentrum Rotenburg an der Fulda Germany end of 2008 after finishing this trial he became an employee of B Braun USA orthopedics and medical affairs Prof Scheller reports being coinventor of a patent application for various methods of restenosis inhibition including the technique employed in this trial by Charité University Hospital Berlin
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