Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter |
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Authors: | Bruno Scheller Christoph Hehrlein Wolfgang Bocksch Wolfgang Rutsch Dariush Haghi Ulrich Dietz Michael Böhm Ulrich Speck |
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Affiliation: | 1. Klinik für Innere Medizin III, Universit?tsklinikum des Saarlandes, Homburg, Saar, Germany 2. Klinik für Innere Medizin III, Universit?tsklinikum, Freiburg, Germany 3. Medizinische Klinik mit Schwerpunkt Kardiologie, Universit?tsklinikum Charité, Campus Virchow-Klinikum, Berlin, Germany 4. Medizinische Klinik und Poliklinik mit Schwerpunkt Kardiologie, Angiologie, Pulmonologie, Charité-Universit?tsmedizin Berlin, Campus Charité Mitte, Berlin, Germany 5. I. Medizinische Klinik, Universit?tsklinikum Mannheim, Ruprecht-Karls-Universit?t Heidelberg, Mannheim, Germany 6. Kardiologie, Deutsche Klinik für Diagnostik, Wiesbaden, Germany 7. Institut für Radiologie, Charité-Universit?tsmedizin Berlin, Campus Charité Mitte, Berlin, Germany
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Abstract: | Background We are presenting an extension of a previously published trial on the efficacy and safety of a paclitaxel-coated balloon in coronary ISR in a larger patient population and after a complete follow-up of 2 years. Methods Hundred eight patients were enrolled in two separately randomized, double-blind multicenter trials on efficacy and safety using an identical protocol. Patients were treated by the paclitaxel-coated (3 μg/mm2 balloon surface; Paccocath) or an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥70% and <30 mm length with a vessel diameter of 2.5–3.5 mm. The primary endpoint was angiographic late lumen loss in-segment. Secondary endpoints included binary restenosis rate and major adverse cardiovascular events (MACE). Results Quantitative coronary angiography revealed no differences in baseline parameters. After six months in-segment late lumen loss was 0.81 ± 0.79 mm in the uncoated balloon group vs. 0.11 ± 0.45 mm (P < 0.001) in the drug-coated balloon group resulting in a binary restenosis rate of 25/49 vs. 3/47 (P < 0.001). Until 12 months post procedure 20 patients in the uncoated balloon group compared to two patients in the coated balloon group required target lesion revascularization (P = 0.001). Between 12 and 24 only two MACE were recorded, a stroke in the uncoated and a target lesion revascularization in the coated balloon group. Conclusion Treatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981). |
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Keywords: | paccocath drug-coated balloon in-stent restenosis |
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