OrbusNeich's Combo Dual-Therapy Stent Meets Primary Endpoint in REMEDEE

November 14, 2011—OrbusNeich (Fort Lauderdale, FL) announced that results from the REMEDEE study confirmed that the company's Combo dual-therapy stent is noninferior to the Taxus Liberté paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA) with respect to in-stent late lumen loss at 9-month angiographic follow-up. Prof. Michael Haude, MD, presented the results at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.

The Combo stent combines an abluminal biodegradable sirolimus elution for the regulation of hyperplasia with the company's Genous endothelial progenitor cell (EPC) capture technology to accelerate re-endothelialization.

According to OrbusNeich, the study's primary objective was to demonstrate the safety and effectiveness of the Combo stent compared to the Taxus Liberté drug-eluting stent (DES) in patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. The study's primary endpoint was noninferiority based on in-stent late lumen loss at 9 months.

At 9-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 DES.

“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 DES,” commented Professor Haude. “However, the real differentiating factor for Combo is the Genous prohealing technology. Using intravascular ultrasound and optical coherence tomography imaging, we saw superb homogenous coverage of the Combo stent struts at 9 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 company stated that the study's secondary endpoints included clinically driven target lesion revascularization, binary restenosis, major adverse cardiac events, and stent thrombosis rates, as well as all-cause and cardiac mortality, myocardial infarction, and target lesion failure at 30 days, 9 months, and 1 through 5 years.

Although the study was not powered to establish statistical significance for the secondary endpoints, the following trends in favor of Combo were observed at 9 months: for patients treated with Combo compared with the Taxus DES group, the rate of clinically driven target lesion revascularization was 45% lower, the binary restenosis rate was 43% lower, and the major adverse cardiac events rate was 21% lower. No stent thrombosis was observed in either cohort.

The company advised that REMEDEE is an ongoing first-in-man, prospective, randomized, multicenter study that includes 183 patients with symptomatic, ischemic 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 diameters from ≥ 2.5 mm and ≤ 3.5 mm, as well as ≤ 20 mm in length. Other characteristics for the Combo group compared with the Taxus DES group included an average reference vessel diameter of 2.77 mm versus 2.85 mm, an average stent length of 13.7 mm versus 14.6 mm, 66.2% versus 61% of lesions treated were type B2/C lesions, and 33.1% versus 37.3% had diabetes mellitus.