Paclitaxel beschichteter Ballon in Kombination mit einem CD34-Antikörper beschichteten Stent zur Therapie der koronaren Herzkrankheit
LicenseCC BY-NC-ND 3.0 Deutschland
Percutaneous coronary intervention with stent implantation is limited by the occurrence of restenosis and the risk for stent thromboses. The combination of paclitaxel coated balloon angioplasty plus endothelial progenitor cell capturing (EPC) stent implantation might properly address both issues, a reduction of neointimal proliferation with a homogenous administration of paclitaxel and a reduction of the risk of stent thrombosis by facilitating rapid endothelialization. Methods: In this prospective, double-blind, multicenter, randomized trial we randomly assigned 120 patients with a de-novo lesion in a native coronary artery to undergo treatment either with paclitaxel coated balloon catheter plus EPC stent or EPC stent alone. Patients were scheduled for control angiography at 6 months. The primary end point was in-stent late lumen loss. The secondary clinical endpoint was composited of death from cardiac cause, myocardial infarction attributed to the target vessel or target lesion revascularization. Results: Treatment with paclitaxel eluting balloon plus EPC stent was superior to EPC stent alone with a late loss of 0.34±0.45 mm versus 0.88±0.48 mm (difference -0.54 mm, 95 % confidence interval, -0.76 to -0.37; P<0.001), respectively. Restenosis was reduced from 23.2 % to 5.1 % (P=0.005) and the clinical end point was reduced from 17.2 % to 4.8 % (P=0.03), respectively. There was no definite or probable stent thrombosis. Conclusions: Paclitaxel coated balloon angioplasty and EPC stent implantation is superior to EPC stent implantation alone for treatment of de-novo coronary artery disease.
Original publicationHeart. 2011 Aug;97(16):1338-42.
Subject HeadingsKoronare Herzkrankheit [GND]
Angioplasta, balloon, coronary [MeSH]
Coronary disease [MeSH]
Drug-eluting stents [MeSH]