OrbusNeich announced that results from the REMEDEE study (Randomised evaluation of an abluminal sirolimus coat ED bio-engineered stent) confirmed that the Combo dual therapy stent is non-inferior to the Taxus Liberte paclitaxel-eluting stent (Boston Scientific), with respect to in-stent late lumen loss at nine-month angiographic follow-up.
The results were presented by Michael Haude, director of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, during the Late Breaking Clinical Trials and First Report Investigations Session at 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) symposium in San Francisco, USA.
The Combo stent, the worlds’ first dual therapy stent (DTS), combines an abluminal biodegradable sirolimus elution for the regulation of hyperplasia with Genous, OrbusNeich’s proven endothelial progenitor cell (EPC) capture technology, to accelerate re-endothelialisation.
The study’s primary objective was to demonstrate the safety and effectiveness of the Combo stent compared to the Taxus Liberte paclitaxel-eluting stent in patients with symptomatic, ischaemic heart disease due to a stenotic lesion located in a native coronary artery. The study’s primary endpoint was non-inferiority based on in-stent late lumen loss at nine months.
At nine-month angiographic follow-up, the in-stent late lumen loss for the Combo dual therapy stent was 0.39 +/- 0.45 mm compared to 0.44 +/- 0.56 mm for the Taxus drug-eluting stent.
“This first clinical experience with the Combo dual therapy stent confirms that Combo achieves an antiproliferative effect and safety profile similar to that of current drug-eluting stents,” said Haude. “However, the real differentiating factor for Combo is the Genous pro-healing technology. Using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging, we saw superb homogenous coverage of the Combo stent struts at nine months, compared to less impressive coverage with Taxus. By harnessing the additive effect of EPC capture to accelerate vessel healing, Combo may potentially enable a significant reduction in the duration of dual antiplatelet therapy in specific cases. These results provide compelling justification for further clinical study of the Combo stent.”
The study’s secondary endpoints included clinically driven target lesion revascularisation, binary restenosis, major adverse cardiac events (MACE) and stent thrombosis rates, as well as all-cause and cardiac mortality, myocardial infarction and target lesion failure at 30 days, nine months and one through five years. Though the study was not powered to establish statistical significance for the secondary endpoints, the following trends in favor of Combo were observed at nine months: for patients treated with Combo, the rate of clinically driven target lesion revascularisation was 45% lower than in the Taxus group, the binary restenosis rate was 43% lower than the Taxus group, and the MACE rate was 21% lower than the Taxus group. No stent thrombosis was observed in either cohort.
“With these exciting results in hand, we have filed our CE mark application for Combo,” said Al Novak, OrbusNeich’s chairman of the board, president and CEO. “Combo’s dual therapy approach was conceived to address the major issue that still faces drug-eluting stents, specifically the risk of stent thrombosis associated with delayed or absent healing. These results place Combo in the running to become the better drug-eluting stent—a drug eluting stent that heals.”
REMEDEE is an ongoing first-in-man, prospective, randomised, multicentre study that includes 183 patients with symptomatic, ischaemic heart disease due to a stenotic lesion located in a native coronary artery at sites in Asia, Australia, Europe and South America. Patients underwent percutaneous coronary intervention for the treatment of single de novo native coronary lesions ranging in diameter from greater than or equal to 2.5 mm and less than or equal to 3.5 mm and less than or equal to 20 mm in length.
The average reference vessel diameter (RVD) was 2.77 mm for the Combo group and 2.85 mm for the Taxus group, and the average stent length was 13.7 mm for Combo and 14.6 mm for Taxus. Of the lesions treated, 66.2% were type B2/C lesions in the Combo group, and 61.0% were type B2/C in the Taxus group. For patients treated with Combo, 33.1% had diabetes mellitus, compared to 37.3% for Taxus.