Enrolment in the REDUCE trial— a physician-initiated, prospective, multicentre, randomised study, designed to evaluate the potential for shorter-term dual antiplatelet therapy (DAPT) in acute coronary syndrome—has reached completion, according to an OrbusNeich press release.
All patients in the trial will receive the Combo dual therapy stent with an abluminal sirolimus drug elution and endothelial progenitor cell (EPC) technology that actively captures EPCs and accelerates formation of healthy endothelial coverage.
“The safety and efficacy of the Combo stent has already been proven in previous trials, but the benefits of accelerated endothelialisation can set this stent apart by enabling a reduced DAPT regimen”, says Harry Suryapranata, principal study investigator from Radboud University Medical Center, Nijmegen, The Netherlands.
“This offers a significant degree of freedom in the treatment of ACS patients. Early discontinuation of DAPT reduces the inherent bleeding risk and the healing characteristics of the COMBO offers great potential in enabling this without compromising overall safety” adds co-principal study investigator, Giuseppe De Luca from the Eastern Piedmont University Hospital, Novara, Italy. “The REDUCE trial is the first study to evaluate the reduction of DAPT following treatment with the Combo stent and may provide us with evidence to support the safety of three months DAPT in ACS patients.”
The REDUCE trial began in June 2014 and has now completed enrolment of 1,500 patients in 36 centres in Asia and Europe. This trial evaluates the composite endpoint of all-cause mortality, any myocardial infarction, target vessel revascularisation, stroke or major bleeding in patients receiving either three or 12 months of DAPT after a period of one year. Patients have been randomised in a 1:1 fashion. The REDUCE study is managed by Diagram Research Organization, The Netherlands.