Combo Dual Therapy Stent (Orbus Neich) safe and effective in Heart Disease trial

A randomized comparison of the Combo Dual Therapy Stent, from Orbus Neich, which combines low-dose sirolimus delivery from an abluminal biodegradable polymer matrix with a covalently bound anti-CD34 antibody layer, with a paclitaxel-eluting stent, showed that the dual therapy stent effectively controls neointimal proliferation and was shown to be safe and effective. The REMEDEE trial was designed to demonstrate the safety and effectiveness of the new stent compared to a clinically proven paclitaxel-eluting stent. The new stent is designed for control of neointimal proliferation as well as accelerated vessel healing. The trial was conducted among patients with symptomatic, ischemic Heart Disease due to a stenotic lesion located in a single native coronary artery. In the study, 183 patients were randomized at 17 sites, and of these 124 subjects were placed in the dual therapy group and 59 in the paclitaxel-eluting group. In-stent late lumen loss at nine months for the dual therapy stent was a mean of .39 � 0.45 mm for the combo and .44 � 0.56 mm in the paclitaxel-eluting stent. At nine months, there were 1% deaths in the combo group, and 0% in the paclitaxel group. The rate of myocardial infarction at nine months was 2.4% in the combo group and 1.7% in the paclitaxel group. And, the rate of major adverse cardiac events (MACE) at nine months was 8.7% in the combo group and 11.0% in the paclitaxel group. Both groups had 0% stent thrombosis at nine months. The dual therapy stent was shown to be safe and effective, as well as non-inferior to the paclitaxel-eluting stent, according to lead researcher Michael Haude, Professor of Internal Medicine at Lukaskrankenhaus Neuss in Germany. Results of the REMEDEE trial were presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.