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  • Title: 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.
    Author: Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B.
    Journal: EuroIntervention; 2015 Dec; 11(8):926-34. PubMed ID: 25169589.
    Abstract:
    AIMS: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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).
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