Ticagrelor monotherapy reduces bleeding, does not impact ischemia after PCI for STEMI
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Among patients with STEMI who underwent PCI with an ultrathin bioresorbable polymer sirolimus-eluting stent, switching to ticagrelor monotherapy after 3 months reduced bleeding risk, according to the TICO-STEMI trial.
Those who underwent PCI with the SES (Orsiro, Biotronik) and were switched to ticagrelor (Brilinta, AstraZeneca) monotherapy at 3 months had no difference in net adverse clinical events compared with those who remained on dual antiplatelet therapy with ticagrelor and aspirin, according to data presented at the virtual TCT Connect.
As Healio previously reported, in the main results of the TICO trial, the monotherapy group had reduced risk for net adverse clinical events, defined as TIMI major bleeding, all-cause death, MI, stroke, stent thrombosis or target vessel revascularization, at 1 year compared with the DAPT group, driven by lower rates of major bleeding. At TCT Connect, Byeong-Keuk Kim, MD, PhD, professor of cardiology and director of the cardiac catheterization and intervention department at Yonsei University Severance Cardiovascular Hospital College of Medicine in Seoul, South Korea, presented results of 1,103 patients with STEMI, who comprised 36.1% of the TICO cohort.
“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT in STEMI patients with [a drug-eluting stent],” Kim said at a press conference.
In the intention-to-treat population, net adverse clinical events occurred in 3.7% of the monotherapy group and 5% of the DAPT group at 1 year (HR = 0.73; 95% CI, 0.42-1.29, Kim said during a press conference.
In the as-treated population, net adverse clinical events were lower at 1 year in those who had monotherapy compared with those who had DAPT (2.3% vs. 5.2%; HR = 0.44; 95% CI, 0.23-0.86), he said.
In a landmark analysis, net adverse clinical events between 90 days and 1 year were similar between the groups (monotherapy, 1.7%; DAPT, 2.1%; HR = 0.83; 95% CI, 0.34-2).
TIMI major bleeding at 1 year was significantly lower in the monotherapy group, regardless of whether it was the intention-to-treat population (0.9% vs. 2.9%; HR = 0.32; 95% CI, 0.12-0.87), the as-treated population (0.8% vs. 2.9%; HR = 0.26; 95% CI, 0.09-0.77) or the landmark analysis population (0% vs. 1.1%; P = .01), Kim said at the press conference.
MACCE, defined as all-cause death, MI, stent thrombosis, stroke or TVR, did not differ between the groups at 1 year in the intention-to-treat population (HR = 1.09; 95% CI, 0.53-2.27), the as-treated population (HR = 0.66; 95% CI, 0.29-1.51) or the landmark analysis (HR = 1.54; 95% CI, 0.55-4.32), according to the researchers.
The researchers also analyzed bleeding outcomes in patients with high bleeding risk and MACCE in those who had complex PCI. In neither case did they find an interaction for the treatment effect of ticagrelor monotherapy.
“In patients with high bleeding risk, ticagrelor monotherapy compared with 12-month DAPT appeared to lower the rate of major bleeding,” Kim said at the press conference, noting the 12-month bleeding rates in that cohort were 1.8% in the monotherapy group and 6.3% in the DAPT group (P = .002). “There was no significant difference in MACCE; however, as compared to the other subsets, patients with complex PCI and ticagrelor monotherapy showed numerically higher rates of MACCE.”
He concluded that “care should be taken in applying these results to the overall STEMI population, especially those at high risk for ischemia.”
Perspective
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Roxana Mehran, MD
The investigators did an amazing job with TICO-STEMI, which consisted of about one-third of the patients from the TICO study. It is the only trial that has looked at ticagrelor monotherapy after 3-month DAPT in this population. But it’s open-label and has a small number of patients. The net adverse clinical events for the ticagrelor monotherapy group did not meet the P value seen in the overall TICO trial, but that does not mean these findings are less important. There was a reduction in bleeding, as expected, without a real increase in ischemic endpoints. This study is in line with the main TICO trial, but given that it is a smaller sample size, we need a larger prospective randomized study in patients with STEMI. Our team hopes to accomplish this with TWILIGHT-STEMI.
Until then, decisions about antiplatelet therapy after PCI for STEMI should be made on a case-by-case basis.
There are a lot of differences between TICO and TWILIGHT, which did not include patients with STEMI. TWILIGHT had a 3-month open-label period, after which patients underwent randomization if they were event-free. In TICO, the randomization occurred straight up at the time of PCI. The TICO researchers say to be cautious in the case of complex patients at high risk for ischemia. It’s important to use good clinical judgment.
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Kim BK, et al. Late-breaking clinical science session I, co-sponsored by Circulation. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).
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