March 30, 2020
TICO Study Shows Benefit for Ticagrelor Alone in Patients With ACS After PCI
March 30, 2020—At the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC), Yangsoo Jang, MD, presented data from the TICO study demonstrating that patients with acute coronary syndrome (ACS) who stopped taking aspirin 3 months after the insertion of a coronary stent and then took ticagrelor alone for 9 months had fewer episodes of bleeding and no increase in heart attacks, stroke, or other adverse events caused by blockages in the arteries, compared with patients who took both aspirin and ticagrelor for a year. TICO was funded by Biotronik, manufacturer of the stents used in the study.
Dr. Jang stated in the announcement from ACC.20/WCC, “This is the first randomized trial to compare ticagrelor monotherapy with dual antiplatelet therapy—the standard of care—exclusively in a population with ACS. 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.”
The TICO study enrolled 3,056 patients with ACS at 38 centers in South Korea. The patients' average age was 61 years; 79% were men, 39% were aged > 65, and 27% had diabetes. All patients received ticagrelor plus aspirin for 3 months, then the patients were randomly assigned to one of two groups. For 9 months, one group continued treatment with ticagrelor and aspirin, while the second group received ticagrelor alone.
The primary study endpoint was the combined occurrence of death, heart attack, stroke, stent thrombosis, the need for a second procedure to unblock the same artery, or major bleeding (defined as fatal bleeding, bleeding inside the skull, or symptomatic internal bleeding) 12 months after stenting.
At ACC.20/WCC, Dr. Jang reported that after a median follow-up of 12 months, 59 (3.9%) patients who had been randomly assigned to ticagrelor alone had a primary-endpoint event, compared with 89 (5.9%) patients who had continued treatment with both ticagrelor and aspirin, a statistically significant difference. This difference was driven by a reduced risk of major bleeding in the group treated with ticagrelor alone (1.7%), compared with the group treated with ticagrelor and aspirin (3%). Rates of other adverse events were similar in the two groups.
A limitation of the study is that patients with an elevated risk for bleeding (defined as age ≥ 80 years, having had a stroke within the past year, or having had brain surgery or a traumatic brain injury within the past 6 months) were excluded. Dr. Jang noted that these patients account for approximately 40% of patients undergoing stenting outside of clinical trials. “Our results cannot be extrapolated to this group of patients,” advised Dr. Jang in the ACC.20/WCC press release.