REDUCE Compares 3- and 12-Month DAPT in ACS Patients Treated With the Combo DES
November 1, 2017—Results from the prospective, multicenter, randomized investigator-initiated REDUCE trial were reported at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium being held October 30 to November 2 in Denver, Colorado.
The background of the study is that the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) treated with a drug-eluting stent (DES) 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.
The REDUCE investigators hypothesized that a reduction in DAPT duration could be achieved without increasing the overall treatment risk by using the Combo dual therapy stent (OrbusNeich), which is designed to foster early re-endothelialization using a luminal anti-CD34 antibody with antiproliferative abluminal sirolimus elution. The investigator-initiated study is funded by OrbusNeich.
As summarized in the TCT announcement, the study is composed of 1,496 patients enrolled from June 2014 to May 2016. The patients, who had acute coronary syndrome and were treated with the Combo dual therapy stent, were randomly assigned to either 3 months (n = 751) or 12 months (n = 745) of DAPT. Clinical follow-ups were scheduled at 3, 6, 12, and 24 months. The primary study endpoint was a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularization (TVR), and bleeding (BARC II, III, V) at 12 months.
The investigators found no difference in the primary endpoint between 3 and 12 months of DAPT (8.2% vs 8.4%; Pnoninferiority < .001; Psuperiority = .88). Among the secondary endpoints, major bleeding rates were similar among the treatment arms (2.5% vs 3.0%; P = .54), with nonsignificantly different rates of overall mortality (1.9% vs 0.8%; P = .07), cardiac mortality (1.1% vs 0.4%; P = .13), and definite/probable stent thrombosis (1.2 % vs 0.4%; P = .08)—however, the study was not powered to assess these individual endpoints.
In the TCT announcement, Harry Suryapranata, MD, commented, “The REDUCE trial shows that among ACS patients treated with a Combo stent, 3 months of DAPT is noninferior to 12 months of DAPT, and this is consistent for all prespecified subgroups. 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.” Dr. Suryapranata is Professor of Interventional Cardiology at Radboud University Medical Center in Nijmegen, The Netherlands.