TICO: Ticagrelor Monotherapy Beneficial Post PCI in Patients With ACS
Patients with acute coronary syndrome (ACS) who discontinued aspirin three months post PCI coronary stenting and continued with ticagrelor only for nine months had fewer episodes of bleeding and no increase in adverse cardiovascular events, compared with patients who continued dual antiplatelet therapy (DAPT) with aspirin and ticagrelor for a year. The results of the TICO trial were presented March 30 in a Late-Breaking Clinical Trial session during ACC.20/WCC.
In what the authors say is the first randomized study to compare standard of care ticagrelor-based DAPT against a strategy with ticagrelor monotherapy in ACS, Yangsoo Jang, MD, PhD, enrolled 3,056 patients with ACS at 38 centers in South Korea between August 2015 and October 2018. Patients underwent PCI with Orsiro ultrathin bioresorbable polymer sirolimus-stents. Their average age was 61 years (39% >65 years), 79% were men and 27% had diabetes. Patients were randomized after the index PCI to 12-month DAPT or DAPT for three months followed by ticagrelor monotherapy.
The primary endpoint was net adverse clinical event (NACE) rate at 12 months, defined as combined occurrence of TIMI major bleeding and all-cause death, myocardial infarction, stent thrombosis, stroke or target vessel revascularization (MACCE).
Results showed for the primary endpoint of NACE, the rate was 3.9% in the ticagrelor monotherapy group and 5.9% in the 12-month DAPT group (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.48-0.92; p=0.01). This difference was driven by a reduced risk of major bleeding in the ticagrelor monotherapy vs. 12-month DAPT group (1.7% vs. 3%; HR, 0.56; 95% CI, 0.34-0.91; p=0.02).
A landmark analysis at three months showed the NACE rate was 1.4% and 3.5% of the ticagrelor monotherapy and 12-month DAPT groups, respectively (HR, 0.41; 95% CI, 0.25-0.68; p=0.001). In this landmark analysis, TIMI major bleeding occurred in 0.26% and 1.5% of the groups, respectively (HR, 0.13; 95% CI, 0.04-0.44; p=0.001).
Between three months and 2 months, three instances of major bleeding occurred in the ticagrelor monotherapy group (0.2%) and 23 in the conventional therapy group (1.6%) (HR, 0.13; 95% CI, 0.04-0.44; p=0.001).
Looking at MACCE, no significant difference was seen between groups (2.3% vs. 3.4% with ticagrelor monotherapy vs. 12-month DAPT) at 12 months. For stent thrombosis, there was a similar rate in the two groups (0.4% and 0.3%, respectively; HR,1.51; 95% CI, 0.43-5.33; p=0.53).
A prespecified subgroup analysis showed that ticagrelor monotherapy had a consistent effect on the primary outcome across subgroups, except in patients with multivessel disease who did better with 12-month DAPT.
The authors note the trial was powered for the NACE composite outcome, and comparisons of the component events could be underpowered, and the overall event rates were observed were lower than anticipated. They also note that patients at high bleeding risk, who account for about 40% of patients undergoing stenting outside of clinical trials, were excluded and the results cannot be extrapolated to this group of patients.
"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," says Jang.
Keywords: ACC Annual Scientific Session, acc20, Aspirin, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Heart Failure
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