COMBO Dual Therapy Stent demonstrates optimal treatment in acute coronary syndrome.- OrbusNeich.

OrbusNeich has reported results from the REDUCE trial demonstrating optimal treatment of patients with acute coronary syndrome (ACS) using the COMBO Dual Therapy Stent. REDUCE is a physician-initiated, prospective, multicenter, randomized study, designed to demonstrate non-inferiority of a strategy of short-term (three months) dual antiplatelet therapy (DAPT) as compared to standard 12-month DAPT in patients with ACS treated with a COMBO stent. The trial found no difference in the primary endpoint between three and 12 months DAPT (8.2% vs. 8.4%) in the intent to treat (ITT) population. The overall incidence of the primary endpoint event (a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularization, moderate and major bleeding (BARC II, III or V)) was low at 8.3% in comparison to the original estimate of 12% based on contemporary trials. Furthermore, the results were consistent across all subgroups (age, gender, STEMI vs non-STEMI, geographic region and diabetes) without any significant statistical interaction. Data were presented at the Late-Breaking Clinical Trial session at the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium.

Comment: COMBO is the only stent with prospective randomized controlled trial-based evidence, to support such a strategy in an ACS population. The optimal duration of dual antiplatelet therapy in ACS patients treated with drug eluting stents is still under debate. The potential benefits of long-term dual antiplatelet therapy in avoiding thrombotic complications may be counterbalanced by a higher risk of major bleeding complications. Per U.S. and European guidelines, dual antiplatelet therapy is typically continued for at least 12 months following percutaneous coronary intervention (PCI) with drug-eluting stents or bare metal stents, primarily based on the CURE trial that was conducted 20 years ago, and the use of first generation drug eluting stents. Therefore, REDUCE provided an opportunity to explore different dual antiplatelet therapy regimens and a new generation stent.