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- Dokumenttyp:
- Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Article
- Autor(en):
- Unverdorben, Martin; Vallbracht, Christian; Cremers, Bodo; Heuer, Hubertus; Hengstenberg, Christian; Maikowski, Christian; Werner, Gerald S; Antoni, Diethmar; Kleber, Franz X; Bocksch, Wolfgang; Leschke, Matthias; Ackermann, Hanns; Boxberger, Michael; Speck, Ulrich; Degenhardt, Ralf; Scheller, Bruno
- Titel:
- Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study.
- Abstract:
- Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented.One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period.The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).
- Zeitschriftentitel:
- EuroIntervention
- Jahr:
- 2015
- Band / Volume:
- 11
- Heft / Issue:
- 8
- Seitenangaben Beitrag:
- 926-34
- Sprache:
- eng
- Volltext / DOI:
- doi:10.4244/EIJY14M08_12
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/25169589
- Print-ISSN:
- 1774-024X
- TUM Einrichtung:
- Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
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