Results from the prospective, multicenter, randomized investigator-initiated REDUCE trial were reported today at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
The optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) treated with a drug-eluting stent is still under debate. The potential benefits of long-term DAPT in avoiding thrombotic complications may be offset by a higher risk of major bleeding complications. Researchers hypothesized that a reduction in DAPT duration could be achieved without increasing the overall treatment risk, by using the COMBO dual therapy stent, a stent designed to foster early re-endothelialization using a luminal anti-CD34 antibody with antiproliferative abluminal sirolimus elution.
From June 2014 to May 2016, 1,496 patients with acute coronary syndrome and treated with the COMBO dual therapy stent were randomly assigned to either three months (N=751) or 12 months (N=745) of DAPT. Clinical follow-ups were scheduled at three, six, 12, and 24 months. The primary study endpoint was a composite of all-cause mortality, myocardial infarction, stent thrombosis (ST), stroke, target-vessel revascularization (TVR), and bleeding (BARC II, III, V) at twelve months.
The trial found no difference in the primary endpoint between three and 12 months DAPT (8.2% vs. 8.4%, Pnoninferiority<0.001; Psuperiority=0.88). Among the secondary endpoints, major bleeding rates were similar among the treatment arms (2.5% vs. 3.0%, P=0.54), with non-significantly different rates of overall mortality (1.9% vs. 0.8%, P=0.07), cardiac mortality (1.1% vs. 0.4%, P=0.13), and definite/probable ST (1.2 % vs. 0.4%, P=0.08), although the study was not powered to assess these individual endpoints.
"The REDUCE trial shows that among ACS patients treated with a COMBO stent, three months of DAPT is non-inferior to 12 months of DAPT, and this is consistent for all pre-specified subgroups" said Harry Suryapranata, MD, PhD, Professor of Interventional Cardiology at Radboud University Medical Center in Nijmegen, The Netherlands. "Therefore, this strategy could be considered if needed, even in ACS population. Future larger trials are needed to further investigate and confirm the safety of short-term DAPT regimen in ACS patients in the era of new ADP antagonists and new generation DES."
The REDUCE trial is an investigator-initiated study funded by OrbusNeich. Dr. Suryapranata reported to have no conflicting personal financial interests, however his institution did receive an unrestricted research grant from OrbusNeich.
Provided by Cardiovascular Research Foundation