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.
Cremers
B
B
Clinic of Internal Medicine III, Saarland University Hospital, Homburg/Saar, Germany.
Clever
Y
Y
Schaffner
S
S
Speck
U
U
Böhm
M
M
Scheller
B
B
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