Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter

• Verfasst von: Scheller, Bruno [VerfasserIn]
• Verfasst von: Haghi, Dariusch [VerfasserIn]
• Titel: Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
• Verf.angabe: BrunoScheller MD, Yvonne P. Clever MD, Bettina Kelsch M.Chem, Christoph Hehrlein MD, Wolfgang Bocksch MD, Wolfgang Rutsch MD, Dariush Haghi, Ulrich Dietz MD, Ulrich Speck PhD, Michael Böhm MD, Bodo Cremers MD
• E-Jahr: 2012
• Jahr: March 2012
• Umfang: 8 S.
• Fussnoten: Gesehen am 20.04.2018
• Titel Quelle: Enthalten in: American College of CardiologyJACC Cardiovascular interventions
• Ort Quelle: New York, NY : Elsevier, 2008
• Jahr Quelle: 2012
• Band/Heft Quelle: 5(2012), 3, Seite 323-330
• ISSN Quelle: 1876-7605
• DOI: doi:10.1016/j.jcin.2012.01.008
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: drug-coated balloon(s)
• Sach-SW: in-stent restenosis
• Sach-SW: PACCOCATH
• K10plus-PPN: 1572199687

Abstract

This study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial. The PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented. This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 μg/mm2 balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone. During a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004).