Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis

Unverdorben, Martin and Vallbracht, Christian and Cremers, Bodo and Heuer, Hubertus and Hengstenberg, Christian and Maikowski, Christian and Werner, Gerald S. and Antoni, Diethmar and Kleber, Franz X. and Bocksch, Wolfgang and Leschke, Matthias and Ackermann, Hanns and Boxberger, Michael and Speck, Ulrich and Degenhardt, Ralf and Scheller, Bruno (2009) Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis. CIRCULATION, 119 (23). pp. 2986-2994. ISSN 0009-7322, 1524-4539

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Abstract

Background-Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care. Methods and Results-One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 mu g/mm(2)) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of >= 70% and >= 22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38 +/- 0.61 mm in the drug-eluting stent group versus 0.17 +/- 0.42 mm (P=0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P=0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (P=0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P=0.15). Conclusions-Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation. ( Circulation. 2009; 119: 2986-2994.)

Item Type: Article
Uncontrolled Keywords: DRUG-ELUTING STENTS; BARE-METAL STENTS; DELIVERY; THROMBOSIS; ANGIOPLASTY; PREVENTION; INHIBITION; EFFICACY; ARTERIES; LESIONS; balloon; drug-eluting stents; restenosis; angioplasty; revascularization
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin II
Depositing User: Dr. Gernot Deinzer
Date Deposited: 14 Sep 2020 07:03
Last Modified: 14 Sep 2020 07:03
URI: https://pred.uni-regensburg.de/id/eprint/28818

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