Effect of Ticagrelor Monotherapy vs Ticagrelor with Aspirin on Major Bleeding and Cardiovascular Events in Patients with Acute Coronary Syndrome: The TICO Randomized Clinical Trial

In the TICO randomized clinical trial, stopping aspirin was tested as a bleeding reduction method after short-term dual anti-platelet treatment (DAPT). However, ticagrelor monotherapy has not been studied in patients with acute coronary syndromes solely (ACS). The objective of this study was to determine whether moving to ticagrelor monotherapy in patients with ACS treated with drug-eluting stents, after 3 months of DAPT lowers net adverse clinical events compared to ticagrelor-based 12-month DAPT. This randomized controlled trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 were included in this trial. The patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529). The primary outcomes assessed was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Out of a total of 3056 patients who were randomized, only 2978 patients (97.4%) completed the trial. The occurrence of primary endpoint happened in 3.9% of patients receiving ticagrelor monotherapy after 3-month DAPT and in 5.9% of patients receiving ticagrelor-based 12-month DAPT with the and a hazard ratio of 0.66. After 3 months of DAPT therapy, major bleeding occurred in 1.7% of patients with ticagrelor monotherapy and in 3% of patients with ticagrelor-based 12-month DAPT with the hazard ration of 0.56. No major difference was observed between the incidence of major adverse cardiac and cerebrovascular events between the ticagrelor monotherapy after 3-month DAPT group and ticagrelor-based 12-month DAPT group. The results of this study demonstrates that among patients with acute coronary syndrome treated with drug-eluting stents, in comparison to ticagrelor-based 12-month dual antiplatelet therapy, ticagrelor monotherapy after 3 months of dual antiplatelet therapy caused significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.