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Results of the TICO study support use of ticagrelor monotherapy for patients with ACS requiring PCI with drug-eluting stents.
Yangsoo Jang, MD, PhD
Results of the TICO trial presented at the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) indicate ticagrelor monotherapy provides greater benefit for patients treated with a drug-eluting stent (DES) for acute coronary syndrome (ACS) compared with ticagrelor-based dual antiplatelet therapy.
The analysis suggested ticagrelor monotherapy was associated with a 34% lower risk of major adverse cardiac and cerebrovascular events and a 44% lower risk of major bleeding compared with ticagrelor plus aspirin.
“This is the first randomized trial to compare ticagrelor monotherapy with dual antiplatelet therapy—the standard of care—exclusively in a population with acute coronary syndrome,” said lead author Yangsoo Jang, MD, PhD, professor of cardiology at Yonsei University College of Medicine in Seoul, South Korea, in a statement. “Our findings suggest that for patients with ACS who are treated with stents, ticagrelor monotherapy could be an optimal strategy for reducing bleeding risk without increasing the risk for adverse events caused by arterial blockages.”
To further assess the efficacy and safety profile of ticagrelor monotherapy for patients with ACS undergoing PCI, Jang and a team of colleagues designed TICO as a randomized, parallel, open-label trial in a population of 3056 patients. Patients included in the trial received ticagrelor dual antiplatelet therapy with aspirin for 3 months before being randomized to ticagrelor plus placebo or ticagrelor plus aspirin for 9 months.
Of the 3056 included in the study, 1527 patients were assigned to ticagrelor plus placebo and 1529 patients were randomized to ticagrelor-based dual antiplatelet therapy with aspirin, which is the current standard therapy. The mean age of study participants was 61 years, 21% were female, and 27% had diabetes.
Inclusion criteria for the study included ACS treated with ultrathin bioresorbable polymer sirolimus-eluting stent and being at least 19 years of age. Exclusion criteria for TICO included being older than 80 years of age as well as having an increased risk of bleeding, need for oral anticoagulation therapy, current or potential pregnancy, bradycardia, and hepatic dysfunction.
The primary outcome measure of the study was net adverse clinical event (NACE) at 12 months. Investigators defined NACE as a composite of TIMI-major bleeding and major adverse cardiac and cerebrovascular, which included all-cause death, MI, stent thrombosis, stroke, or target vessel revascularization.
Upon analysis, results indicated the primary outcome had occurred in 3.9% (n=59) of patients receiving ticagrelor plus placebo compared to 5.9% (n=89) of patients in the ticagrelor plus aspirin (HR, 0.66; 95% CI, 0.48-0.92; P=.01). Investigators pointed out the difference was primarily driven by a lower risk of major bleeding observed with use of ticagrelor plus placebo (1.7% vs. 3.0%; HR=0.56; 95% CI, 0.34-0.91; P=.019). Of note, major adverse cardiac and cerebrovascular events occurred similarly between the 2 treatment arms (HR, 0.69; 95% CI, 0.45-1.06; P=.09).
Investigators noted their study was limited by inclusion criteria and the study was funded by Biotronik, who manufactures the stents used in TICO.
This study, “Ticagrelor With Or Without Aspirin In Acute Coronary Syndrome After Percutaneous Coronary Intervention: Randomized Evaluation Of Ticagrelor Monotherapy After 3-month Dual-antiplatelet Therapy In Acute Coronary Syndrome,” was presented at ACC.20/WCC.