REMEDEE is a 1000-patient registry designed to evaluate the Combo Dual Therapy Stent for the treatment of coronary lesions in the routine clinical care setting. The outcomes demonstrate clinical effectiveness in one-year target lesion failure.
OrbusNeich have announced the presentation of the one-year clinical outcomes from the REMEDEE Registry by Robbert de Winter of Academic Medical Center, Amsterdam, and the principal investigator of the study during the 2015 annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco.
The registry’s primary end point of one-year target lesion failure (TLF) was reported at the incidence of 5.7%, where TLR is defined as an independently adjudicated hierarchical composite of cardiac death (CD), target vessel myocardial infarction (TV-MI) not clearly attributable to a non-target vessel, or target lesion revascularisation (TLR) by percutaneous coronary intervention (PCI) or by coronary artery bypass grafting (CABG). The individual cardiac event rates reported were 1.7% CD, 0.7% TV-MI, and 4.4% ischemia driven TLR. The registry also showed a very low stent thrombosis rate of 0.6%. There was no incidence of late stent thrombosis; all thrombotic events occurred within the first nine days after implant.
According to OrbusNeich, the REMEDEE registry is a true “all comers” study with patient risk factors that include 18.4% diabetics, 58% hypertension, 56.2% hypercholesterolemia and 37% prior revascularisation. Thirty per cent of the patients presented with Acute Coronary Syndrome (ACS), comprised of ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI) and unstable angina, whilst an additional 10% of the patients had stabilized ACS. Of the lesions treated, 50% were of type B2 and C.
The REMEDEE Registry is a prospective, multi-centre, post market all-comers registry that has enrolled 1,000 patients from nine European high-volume percutaneous coronary intervention centres, and is designed to evaluate Combo’s safety and performance. “The one-year outcomes have provided real-world insights that support clinical effectiveness and safety of Combo in terms of low ischemic and thrombotic event rates,” said de Winter.
Other data showcased at TCT 2015 included highlights of the clinical trial program for Combo. During the Didactic Symposia Session focusing on the latest metallic DES technology, an update on the Japan–US HARMONEE (Harmonized assessment by randomised, multi-centre study of OrbusNeich’s Combo Stent) trial was presented in support of the company’s planned application for Combo approval in Japan and the US. “With enrolment well under way, we are looking forward to evaluating for the first time how both physiologic and anatomic measures can assess long-term outcomes, as well as using the most technologically advanced high-resolution imaging to show vascular healing,” says Roxana Mehran, director of interventional cardiovascular research and clinical trials, Mount Sinai Medical Center, United States.
Stephen W.L. Lee, of the Queen Mary Hospital, Hong Kong also presented 2-year OCT findings and 3-year clinical follow up from the EGO-COMBO study. The results supported Combo’s early healing benefits with a near 80% coverage at 2 months. Stability in the long-term was also observed with progressive neointimal maturation without development of late stent failure up to three years. Significant neointimal regression was observed from 9 to 24 months, a phenomenon unseen with conventional metallic DES.