Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
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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.
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).
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.
Treatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).
Keywordspaccocath drug-coated balloon in-stent restenosis
The authors thank Matthias Braeutigam, MD, Schering AG Berlin, for supporting basic experiments leading to the clinical studies. The authors further thank Wolfgang Gimbel, MD for clinical monitoring, Bettina Kelsch for critical data review and report writing, Bianca Werner and Nicole Hollinger for handling the database, and Kevin Wilhelmi for assistance in quantitative analysis of coronary angiographies. Statistical analysis was supported by BIAS GmbH, Berlin, Germany.
Disclosures: The study was supported by Bavaria Medizintechnik GmbH, Oberpfaffenhoven and Bayer-Schering Pharma AG, Berlin, both Germany. Dr. Scheller and Dr. Speck report being co-inventors of a patent application for various methods of restenosis inhibition, including the technique employed in this trial, by Charité University Hospital, Berlin. Dr. Speck reports serving as a consultant to Bayer-Schering AG, Berlin.
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