The combined treatment strategy of paclitaxel-coated balloon and endothelial progenitor cell (EPC) stent implantation demonstrated superiority for the endpoint of less late loss than stenting alone for the treatment of de novo coronary artery disease.
Results of the prospective, randomised, multicentre PERFECT STENT study were presented by Jochen Wohrle, University of Ulm, Ulm, Germany, at the TCT conference in Washington, DC, USA. “Significantly greater proximal, in-stent and distal reductions of late losses were observed at six months in the drug-eluting balloon treatment group,” he said.
The study compared a paclitaxel-coated balloon (SeQuent Please, B Braun) plus an epithelial-progenitor-cell capture stent (Genous Bio-engineered R stent, OrbusNeich) alone. The trial randomised 120 patients aged >18 years, with lesion in native coronary artery, de novo stenosis, indication for PCI, reference diameter between 2.5 and 4.0mm and lesion length ≤25mm.
Six-month follow-up data indicated that the in-segment in the drug-eluting balloon arm of the study was 0.16mm compared with 0.61mm in the stent arm (p<0.001). In-stent late loss was 0.34mm in the balloon arm and 0.88mm in the stent alone arm (p<0.001). A significantly lower binary in-stent restenosis rate in the combination treatment arm, 5.1% vs. 21.4%, was observed. The combination arm had a reduced per cent diameter stenosis, a significantly larger minimal lumen diameter, and reduction in major adverse cardiac events from 17.2% to 4.8%, which was driven by a reduction in TLR of 4.8% vs. 15.5% (p=0.05). There were no occurrences of ST in either arm.
The study concluded that the combined treatment strategy with paclitaxel-coated balloon and EPC stent implantation compared with EPC stent implantation alone for treatment of de novo coronary artery disease showed a significantly lower late loss (primary endpoint), lower binary restenosis rate, percent diameter stenosis and a significantly larger minimal lumen diameter at follow-up, significantly lower combined clinical endpoint and no definite or probable stent thrombosis.