Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich’s Combo StEnt (Japan-USA HARMONEE) study: Primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome
European Heart Journal Jun 27, 2018
Saito S, et al. - Researchers present the findings of Harmonized Assessment by Randomized Multicentre Study of OrbusNEich’s Combo StEnt (HARMONEE), a randomized pivotal registration trial, wherein they tested Combo stent. This stent combines sirolimus and an abluminal bioabsorbable polymer with a novel endoluminal anti-CD34+ antibody coating intended to capture endothelial progenitor cells (EPC) and help percutaneous coronary intervention site healing. They analyzed clinically stable PCI subjects and randomly divided them 1:1 to receive Combo or everolimus-eluting stents (EES). Combo stent vs EES was non-inferior for target vessel failure and late loss at 1-year, and had superior strut-based tissue coverage by optical coherence tomography as a surrogate of EPC capture technology activity.
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