Orbus Neich released the results from their Reduce trial, providing fresh insight into the optimal treatment of patients with acute coronary syndrome (ACS) using the Combo dual therapy stent.
Combo is a dual therapy stent designed to repair vessel injury and regenerate endothelium through a combination of endothelial progenitor cell (EPC) capture technology and a sirolimus drug elution, delivered from a bioresorbable polymer that is completely dissolves within 90 days. The technology consists of an antibody surface coating that captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
The standard recommendation is 6-12 months of DAPT for patients with stable angina treated. However, since long-term DAPT can increase risk of major bleeding complications, the study aimed to determine whether DAPT could be reduced in ACS patients while avoiding complications.
The Reduce trial was conducted in 36 hospitals in Europe and Asia. 1,500 patients with ACS were chosen to undergo treatment with the Combo dual therapy stent. The patients were randomly assigned to either three or 12 months of DAPT, with follow-ups scheduled at 3, 6, and 12 months.
The researchers assessed a composite of all-cause mortality, myocardial infarction, stent thrombosis (ST), stroke, target-vessel revascularization, and bleeding at 12 months as the primary endpoint.
Professor Dato’ Dr. Wan Azman Bin Wan Ahmad, cardiologist at University Malaya Medical Centre, noted that the trial found no difference in the endpoints between three months and 12 months of DAPT. On top of that, the results demonstrated that major bleeding rates were similar in both treatment arms, with similar rates of overall mortality, cardiac mortality, and definite or probable ST.
“The REDUCE trial shows that among ACS patients treated with a Combo stent, three months of DAPT is non-inferior to 12 months of DAPT, and this is consistent for all pre-specified subgroups,” said Harry Suryapranata, MD, PhD, Professor of Interventional Cardiology at Radboud University Medical Center in Nijmegen, The Netherlands, and one of the Principal Investigators who presented the data at TCT.
“Therefore, this strategy could be considered if needed, even in an ACS population. Future larger trials are needed to further investigate and confirm the safety of short-term DAPT regimen in ACS patients, particularly, in the era of new adenosine diphosphate (ADP) antagonists and new generation DES.”