Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBOTM Dual-Therapy StEnt

Zwolle, 2 May, 2016 – The Principal Investigators of the REDUCE trial announce the enrollment of the last patient in the REDUCE trial with the OrbusNeich COMBO Dual Therapy Stent.

After inclusion of the first patient in June 2014, a total of 1500 patients have been included in 36 hospitals in 10 countries in Asia and Europe.

Background

The optimal duration of dual antiplatelet therapy (DAPT) 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.

Objective
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 COMBO Stent.

Study Design
The REDUCE study is a prospective, multicenter, randomized, investigator-initiated study designed to enroll 1500 patients with ACS who have received a COMBO Dual Therapy Stent. Patients have been randomized 1:1 to either short term (three months) or standard (12 months) of 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. Diagram is the appointed contract research organization for the REDUCE study.

Patient Population
The study population consists of 1500 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.

Primary Endpoint
The primary endpoint of the study is a Composite of all cause mortality, Myocardial Infarction (MI), stent thrombosis (ST), stroke, target vessel revascularization (TVR) or bleeding (BARC II, III, V) at 12 months.

Principal Investigators 
Prof. H. Suryapranata, MD, PhD, Radboud University Medical Center, Nijmegen, The Netherlands
Prof. G. De Luca, MD, PhD, Eastern Piedmont University Novara, Italy

For more information about the REDUCE trial, please visithttps://clinicaltrials.gov/ct2/show/NCT02118870

About OrbusNeich

OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world’s first dual therapy stent, the COMBO Dual Therapy Stent, and the world’s first pro-healing stent, the Genous™ Stent. Other products include stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit http://www.OrbusNeich.com

About Diagram

Diagram is a globally operating full service Contract Research Organization (CRO) with two Site Management Organizations (SMO). Diagram is able to support with the development, organization and execution of clinical scientific research. Diagram was founded in 1996 in the Netherlands. In the past years, Diagram has acquired considerable expertise in supporting cardiovascular research. The quality management of Diagram (NEN-EN-ISO 9001:2008 certified); strong ICT, data management and statistics department; own SMO’s, and international focus makes Diagram different from other CRO’s. Please visit www.diagramresearch.com.

Contact details

For more information please contact Diagram: +31 38 4262999 orreduce.study@diagramresearch.com.