Postmarket REMEDEE Registry Data Presented for OrbusNeich's Combo Stent

October 19, 2015—OrbusNeich announced that 1-year clinical outcomes from the 1,000-patient REMEDEE registry were presented by Principal Investigator Robbert de Winter, MD, at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, held October 11-15, in San Francisco, California. 

The REMEDEE Registry is a prospective, multicenter, postmarket all-comers registry that is designed to evaluate the safety and performance of OrbusNeich’s Combo dual-therapy stent for the treatment of coronary lesions in the routine clinical care setting. The registry has enrolled 1,000 patients from nine European high-volume percutaneous coronary intervention (PCI) centers.

Dr. de Winter, who is from the Academic Medical Center in Amsterdam, the Netherlands, commented in the company’s press release, “The 1-year outcomes have provided real-world insights that support clinical effectiveness and safety of Combo in terms of low ischemic and thrombotic event rates.”

According to OrbusNeich, the REMEDEE registry’s primary endpoint of 1-year target lesion failure (TLF) rate was 5.7%, where TLF is defined as an independently adjudicated hierarchical composite of cardiac death, target vessel myocardial infarction (TVMI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) by PCI or by coronary artery bypass grafting.

The individual cardiac event rates reported were 1.7% cardiac death, 0.7% TVMI, 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 9 days after implantation. 

The REMEDEE registry is composed of an all-comers patient population with risk factors that include diabetes (18.4%), hypertension (58%), hypercholesterolemia (56.2%), and previous revascularization (37%). Additionally, 30% of the patients presented with acute coronary syndrome (ACS), composed of ST-elevation myocardial infarction (STEMI), non-STEMI, and unstable angina; and an additional 10% of the patients had stabilized ACS. OrbusNeich reported that of the lesions treated, 50% were type B2 and C.

Also at TCT 2015, an update on the company’s HARMONEE trial was presented in support of the company’s planned application for approval of the Combo device in Japan and the United States. Roxana Mehran, MD, Director of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai Medical Center in New York, New York commented, “With enrollment 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.” 

Two-year optical coherence tomography findings and 3-year clinical follow-up from the EGO-COMBO study were presented by Prof. Stephen W.L. Lee, MD, of the Queen Mary Hospital in Hong Kong, China. The results support Combo’s early healing benefits, with approximately 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 3 years. OrbusNeich noted that significant neointimal regression was observed from 9 to 24 months.