Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry
Abstract
Background
The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent.
Methods and results
The prospective, multicenter, investigator-initiated, all-comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow-up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3-year follow-up there were only 73 patients taking DAPT.
Conclusions
At 3-year follow-up, patients treated with COMBO stent in the present large prospective all-comers cohort, continue to show good clinical outcomes.
Clinicaltrials.gov identifier: NCT01874002.
Condensed abstract
The COMBO stent is a sirolimus-eluting stent with a luminal anti-CD34-antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all-comers patients treated with COMBO stent. Target lesion failure at 3 year follow-up was 10.7% and the rate of definite ST was 0.7%.
CONFLICT OF INTEREST
Dr. Menown has received grant support from Boston Scientific and Biosensors.
Dr. den Heijer is a consultant for Medtronic CoreValve and Direct Flow Medical.
Dr. van ‘t Hof has received grant support from The Medicines Company and Abbott Laboratories.
Prof Dr. de Winter has received grant support from OrbusNeich, Abbott Laboratories, AstraZeneca, Stentys, and Tryton; and consults for OrbusNeich.
All other authors have reported that they have no conflicts of interest.
