First Patient Enrollment Study of Shorter-term Dual Antiplatelet Therapy in ACS Patients With OrbusNeich Stent
August 15, 2014 — OrbusNeich announced first patient enrollment in the Randomized Evaluation of short-term Dual anti platelet therapy in patients with acute coronary syndrome treated with the Combo Dual Therapy StEnt (REDUCE) Study. The study is designed to evaluate the potential for shorter-term dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) patients treated with the Combo Dual Therapy Stent. The physician-initiated, prospective, multicenter, randomized study will enroll 1,500 patients in up to 30 centers in Asia and Europe.
Patients will be randomized in a 1:1 fashion to receive either three or 12 months of DAPT. The study’s primary endpoint is the composite of all-cause mortality, any myocardial infarction (MI), Target Vessel Revascularization (TVR), stroke and major bleeding from enrollment to 12 months.
The REDUCE study will be managed by Diagram Diagnostic Research and Management. Principal investigators are Prof. Harry Suryapranata of the Radboud University Medical Center, Nijmegen, The Netherlands; and Prof. Giuseppe de Luca of Novara Hospital, Novara, Italy. E. Kedhi, M.D., Ph.D., performed the first implant at Isala Hospital in The Netherlands.
“The dual therapy approach of the Combo Stent maintains the efficacy of monotherapy drug eluting stents while providing the benefits of accelerated stent endothelialization and healing,” said Suryapranata. “For this reason, the Combo Stent may enable us to safely reduce the duration of DAPT.”
“This would be a significant achievement, as DAPT causes a number of challenges and limitations for patients because of the potential for side effects such as significant bleeding events,” added de Luca. “The REDUCE trial is the first study to evaluate the reduction of DAPT following treatment with the Combo Stent in a randomized trial and may provide us with evidence to support the safety of three months DAPT in ACS patients.”
“The first patient enrollment in the REDUCE trial represents a critical milestone for our company, for cardiologists and for patients,” said B. Wayne Johnson, president and chief operating officer of OrbusNeich. “The trial demonstrates our commitment to taking a serious look at the ‘duration of DAPT’ question. We look forward to providing cardiologists and patients a definitive answer for how long DAPT is required with our novel approach to true arterial vessel healing.”
For more information: www.diagram-zwolle.nl.