OrbusNeich have announced the initiation of patient enrolment in the randomised clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent). A prospective, randomised, multicentre study, REMEDEE (Randomized evaluation of an abluminal sirolimus coated bio-engineered stent) will enrol 180 patients at up to 20 sites in Asia, Australia, Europe and South America. The primary objective is to demonstrate the safety and effectiveness of the Combo Stent compared to the Taxus Liberte paclitaxel-eluting stent (DES) in the treatment of single de novo native coronary lesions ranging in diameter from 2.5 mm to 3.5 mm and 20 mm in length or shorter.
The study population will consist of patients with symptomatic, ischaemic heart disease due to a stenotic lesion located in a native coronary artery. The primary endpoint is in-stent late lumen loss of the Combo Stent compared to DES at nine months post-procedure. Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, major adverse cardiac event (MACE) and stent thrombosis rates at 30 days, nine months and one to five years, as well as clinically driven target lesion revascularization (TLR), target vessel revascularisation (TVR) and target lesion failure (TLF) rates at the same follow-up times.
The first patient enroled in the REMEDEE study is a 48-year-old male with a lesion located in the proximal left anterior descending artery. The stent was successfully inserted at John Hunter Hospital in Newcastle, Australia, by Dr Greg Bellamy and Dr Sukumaran Thambar. “We are pleased to be the initiating centre for this trial and to work with such a high calibre of experts to evaluate the clinical utility of the Combo Stent,” said Dr Thambar. “This innovative technology potentially represents the next generation of coronary stents.”
The Combo Stent is designed to combine the pro-healing technology used in OrbusNeich’s Genous Bio-engineered R stent for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. The low dose sirolimus elution is accomplished through the use of the SynBiosys biodegradable polymer matrix from SurModics, Inc.
“The pre-clinical work has shown the effectiveness of combining the endothelial progenitor cell capture technology to promote endothelialisation coupled with the low dose, abluminal sirolimus elution to regulate hyperplasia,” said Ian T Meredith, professor of cardiology, director of MonashHeart and Executive Director of the Monash Cardiovascular Research Centre, Melbourne, Australia, one of the trial’s principal investigators. The other principal investigators are Stephan Windecker, director of invasive cardiology at the University Hospital Bern in Switzerland, and Alexandre Abizaid, director of the catheterisation laboratory at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil. “The Combo Stent could be the best of both worlds approach for patients at the highest risk of restenosis,” Meredith added.
“The Combo Stent has demonstrated significantly lower neointimal hyperplasia, improved endothelial coverage relative to commercially available drug-eluting stents and lower presence of inflammation and foreign body reaction in multiple pre-clinical studies,” said Renu Virmani, president and medical director of CVPath Institute, Inc. “Furthermore, I have long believed that the next generation of stents can benefit from biodegradable polymers. The data I’ve seen on the SynBiosys biodegradable polymer suggest it is very biocompatible with low inflammatory scores that could also result in improved endothelialisation.”