The Principal Investigators of the REDUCE trial announced the enrolment of the first patient in the REDUCE trial with the OrbusNeich Combo dual therapy stent at Isala Hospital, Zwolle, the Netherlands.
According to the local PI and treating physician, Dr Kedhi, the 81-year-old female patient was successfully treated with the COMBO stent. The patient consented enrolment in the trial, and was randomized to one of the two treatment arms involving either three months or 12 months of Dual Antiplatelet Therapy (DAPT).
The optimal duration of dual antiplatelet therapy in ACS patients treated with DES is still under debate. This is especially true for STEMI patients in the era of new anticoagulants and antiplatelet agents. Yet the potential benefits of long-term dual antiplatelet therapy in avoiding thrombotic complications may be clearly counterbalanced by a higher risk of major bleeding complications.
In particular, the Combo dual therapy stent, being associated with early re-endothelialization, may allow for a reduction of the duration of DAPT without increasing the thrombotic risk, while reducing the risk of severe bleeding complications.
It is the aim of the current study to demonstrate non-inferiority of a strategy of short-term DAPT (three months) as compared to standard 12-month DAPT in ACS patients treated with the COMBO stent.
The REDUCE study is a prospective, multicenter, randomized, investigator-initiated study designed to enroll 1,500 patients with ACS who will receive a Combo dual therapy stent.
Patients will be randomized 1:1 to either short term (three months) or standard (12 months) DAPT within the hospitalization period (before discharge in case additional revascularization is deemed necessary and performed during hospitalization).
Clinical follow-ups are scheduled at three, six, 12 and 24 months. Thirty hospitals in Asia and Europe will participate in the study. Diagram is the appointed contract research organization for the REDUCE study.
The study population will consist of up to 1,500 ACS patients (male and female) older than 18 years who have been treated with the Combo stent. Subjects must meet all of the eligibility criteria and provide written informed consent.
The primary endpoint of the study is composite of all-cause mortality, myocardial infarction, stent thrombosis , stroke, target vessel revascularization or bleeding (BARC II, III, V) at 12 months.