New research reveals Genous Bio-engineered R stent is safe and effective in combination with drug-eluting balloon
Published date : 19 July 2010
Article date : 19 July 2010
Six-month clinical follow-up data presented at the World Congress of Cardiology Scientific Sessions 2010 in June, showed the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please, B.Braun) followed by implantation of the Genous Bio-engineered R stent (OrbusNeich) for the percutaneous treatment of coronary artery stenosis.
Study design
In the investigator-initiated, single centre, all-comers POTENT (Paclitaxel-eluting ballOon and bio-engineered progeniTor cEll-attracting stainless steel steNT in percutaneous treatment of coronary artery stenosis) registry, 32% of patients were diabetic, 86% were male, 58% had a previous myocardial infarction and the mean age of the study population was 56 years. Of the lesions treated, 46% were type B2/C lesions. The patients received a pre-loading of dual antiplatelet therapy (DAPT) at least six hours prior to the percutaneous coronary intervention, and the DAPT was continued for three months. There were no in-hospital or 30 day major adverse cardiac events (MACE) reported. There was one case of late stent thrombosis.
In the six-month clinical follow-up of the 50 patients in the study, the MACE rate was 6%, and the clinical driven target lesion revascularisation (TLR) rate was 4%. In an optional nine-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis.
“We are very encouraged by the low MACE and binary restenosis rates, which are comparable to other stenting strategies and demonstrate the potential for combining drug-eluting and pro-healing technologies,” said Dr Tiong-Kiam Ong, Sarawak General Hospital, Malaysia, and principal investigator of the study. “This therapeutic strategy could be a potent remedy for the dual problem of in-stent restenosis and stent thrombosis.”
