Treatment of coronary in-stent restenosis with a novel paclitaxel urea coated balloon.
Randomized clinical trials investigating the treatment of coronary in-stent restenosis with paclitaxel iopromide coated balloon catheters have shown favorable results. The aim of the present clinical investigation was to assess the efficacy of a novel paclitaxel urea coated angioplasty balloon in the treatment of coronary in-stent restenosis. A total of 26 restenotic bare metal stents in 23 patients with a lesion length of 22.8 ± 11.1 mm and a reference vessel diameter of 2.64 ± 0.31 mm were treated. Up to six months and including the six-month angiographic control, only one target lesion revascularization was necessary; in total, the rate of major adverse cardiovascular events until six-month follow-up was 4.3 %. In-stent late lumen loss was 0.07 ± 0.37 mm, in-segment late lumen loss 0.02 ± 0.50 mm. Binary restenosis was present in one patient (4.3%). The results of this first-in-human series with a paclitaxel urea coated balloon are comparable to paclitaxel iopromide coated balloon catheters. Randomized, controlled clinical trials are warranted to further evaluate this promising approach.
Clinic of Internal Medicine III, Saarland University Hospital, Homburg/Saar, Germany.
B
B
Cremers
Y
Y
Clever
S
S
Schaffner
U
U
Speck
M
M
Böhm
B
B
Scheller
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D057785:Catheters; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000188:drug therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use*; D015607:Stents; D014508:Urea / Q000737:chemistry
D014508:Urea; D017239:Paclitaxel