Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
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...
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| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
March 2012
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| In: |
JACC Cardiovascular interventions
Year: 2012, Jahrgang: 5, Heft: 3, Pages: 323-330 |
| ISSN: | 1876-7605 |
| DOI: | 10.1016/j.jcin.2012.01.008 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1016/j.jcin.2012.01.008 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S1936879812000714 
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| Verfasserangaben: | 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 |
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| 245 | 1 | 0 | |a Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter |c 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 |
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| 520 | |a 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). | ||
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