Abstract 11324: Clinical Efficacy of Treatment of Coronary in-Stent Restenosis with Drug Eluting Balloon Catheter — New Standard of Care?
Background: Coronary in-stent restenosis (ISR) remains an Achilles' heel of percutaneous coronary intervention (PCI) even in the drug-eluting stent era, where repeat percutaneous treatment often results in high rate of repeat revascularization. We report the clinical efficacy and safety of the use of a novel drug-eluting balloon (DEB) for the treatment of ISR in a real-world population.
Methods: Between Apr 2009 and Apr 2010, all patients with clinical coronary ISR after either bare-metal or DES implantation were analysed. They were treated with a novel paclitaxel-eluting balloon catheter (DIOR™, Eurocor GmbH, Germany) after initial lesion balloon dilatation. The study endpoints were major adverse cardiac events (MACE) of death, myocardial infarction (MI), repeat target vessel revascularization (TVR) and stent thrombosis at 1 month and 6 months.
Results: A total of 41 patients were enrolled in the study. The mean age was 63.3 years old and males constitute 82.2% of the cohort. Diabetes mellitus was present in 22 (48.9%) pts. Seventeen (37.8%) pts received prior DES and majority (77.8%) of the ISR pattern was of the diffuse proliferative type. The pre-procedural reference vessel diameter was 2.4±0.6mm and minimal luminal diameter 0.25±0.2mm. The mean lesion length was 23.2±9.5 mm. The mean DEB size used was 2.91±0.5mm and the mean pressure of inflation and time of inflation were 46.9±9.5 atmospheres and 16.0±2.0 seconds respectively. The MACE at 1 and 6 month were as follow(attached table):
Conclusions: The use of DEB in patients with coronary ISR offers an alternative treatment with low rate of TVR (9.0%). However a study of larger sample size will be needed to fully evaluate its clinical efficacy.
- © 2010 by American Heart Association, Inc.