One-year follow-up data from the REMEDEE study showed favourable clinical and safety outcomes involving the use of the Combo Dual Therapy Stent, from OrbusNeich, when compared to the Taxus Liberte paclitaxel-eluting stent. The data were presented by Michael Haude, Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, on 15 May 2012 at EuroPCR 2012.
In the 12-month follow-up data set, the clinically driven target lesion failure rate was 8.9% for patients treated with the Combo Stent, compared to 10.2% for those treated with the Taxus stent. Clinically driven target lesion failure was defined as a composite of death, myocardial infarction and clinically driven target lesion revascularisation. In addition, the rate of clinically driven target lesion revascularisation was 4.9% for patients treated with the Combo Stent, compared to 8.5% for those treated with Taxus. There was no stent thrombosis in either of the groups.
“The in-stent and in-segment late loss and binary restenosis rates were accordingly low for the Combo Stent and comparable to those of the Taxus stent,” said Haude. “Additionally, we saw a uniform, homogeneous neointimal response with the Combo Stent, compared to the more heterogeneous and layered neointimal tissue appearance with the Taxus stent. Other data are being presented this week, and we look forward to presenting two-year follow-up and other results of the REMEDEE study at upcoming conferences.”
REMEDEE (Randomized evaluation of an abluminal sirolimus coated bio-engineered stent) is a randomised clinical trial designed to demonstrate the safety and efficacy of the Combo Dual Therapy Stent compared to the Taxus 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. The in-stent late lumen loss for the Combo Stent was 0.39 +/- 0.45mm, compared to 0.44 +/- 0.56mm for the Taxus stent. The results were presented late last year during the Late Breaking Clinical Trials and First Report Investigations Session at Transcatheter Cardiovascular Therapeutics (TCT) 2011 in San Francisco. 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.
Ulf Landmesser, professor of cardiology and head of acute and co-head of invasive cardiology at the Cardiovascular Center, University Hospital of Zurich presented the study design for the REMEDEE OCT trial.
The REMEDEE OCT study will assess vascular healing after deployment of the Combo Stent in patients with acute coronary syndrome with single de novo native coronary artery lesions ranging in diameter from greater than or equal to 2.5mm to less than or equal to 3.5mm and less than or equal to 20mm in length. The REMEDEE OCT study, a prospective, multicentre, randomised study, will enrol 60 patients with acute coronary syndrome who will be randomised 1:1 to be treated with the Combo Stent versus the commercially available everolimus-eluting stent. The primary endpoint of the study is the percentage of uncovered stent struts per stent at 60 days post procedure determined by OCT. Secondary clinical endpoints include stent thrombosis and MACE at 30, 60, 180, 360 and 540 days. MACE is defined as a composite of death, myocardial infarction, emergent coronary artery bypass surgery, or justified target lesion revascularisation.
“Currently, 55 patients have been enrolled in the REMEDEE OCT study, and we anticipate to complete the enrollment in the next couple of weeks,” said Landmesser. “The data will be presented at a conference later this year.”