Ticagrelor monotherapy beneficial after PCI with ultrathin SES
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Among patients with ACS who underwent PCI with an ultrathin biodegradable polymer sirolimus-eluting stent, ticagrelor monotherapy after 3 months was superior at preventing net adverse clinical events compared with prolonged dual antiplatelet therapy with ticagrelor and aspirin, according to the results of the TICO trial.
TICO enrolled 3,056 patients with ACS (mean age, 61 years; 80% men) who had PCI with the SES (Orsiro, Biotronik). At 1 year after the procedure, the primary outcome of net adverse clinical events, defined as TIMI major bleeding, all-cause death, MI, stroke, stent thrombosis or target vessel revascularization, occurred in 3.9% of patients assigned ticagrelor (Brilinta, AstraZeneca) monotherapy after 3 months of DAPT vs. 5.9% of patients assigned continued DAPT (HR = 0.66; 95% CI, 0.48-0.92), researchers reported at the virtual American College of Cardiology Scientific Session.
In a prespecified landmark analysis, net adverse clinical events between 3 months and 1 year after the procedure were less common in the monotherapy group (1.4% vs. 3.5%; HR = 0.41; 95% CI, 0.25-0.68), Yangsoo Jang, MD, PhD, interventional cardiologist at Severance Cardiovascular Hospital and professor of cardiology and dean of Yonsei University College of Medicine, Seoul, South Korea, said during a presentation.
The primary outcome was driven by major bleeding, Jang said. At 1 year, TIMI major bleeding occurred in 1.7% of the monotherapy group vs. 3% of the DAPT group (HR = 0.56; 95% CI, 0.34-0.91), whereas between 3 months and 1 year, it occurred in 0.2% of the monotherapy group vs. 1.6% of the DAPT group (HR = 0.13; 95% CI, 0.04-0.44).
MACCE, defined as all primary outcome events except major bleeding, did not significantly differ between the groups at 1 year (monotherapy, 2.3%; DAPT, 3.4%; HR = 0.69; 95% CI, 0.45-1.06) or between 3 months and 1 year (monotherapy, 1.2%; DAPT, 2.1%; HR = 0.58; 95% CI, 0.33-1.04), he said.
“The observed overall event rates for the primary outcome including MACCE and major bleeding were lower than anticipated,” he said.
The individual components of MACCE did not differ between the groups, whereas the outcome of TIMI major or minor bleeding favored the monotherapy group (3.6% vs. 5.5%; HR = 0.64; 95% CI, 0.45-0.9), Jang said.
The treatment effect of the monotherapy strategy was more pronounced in those who did not have multivessel disease than in those who did (P for interaction = .04), he said.
Randomization was conducted after PCI and was based on diabetes status and severity of ACS, and patients at high bleeding risk were excluded, he said, noting that unlike the TWILIGHT study, TICO was open-label and not placebo-controlled.
“This finding indicates that ticagrelor monotherapy could be an optimal strategy, balancing both ischemic and bleeding risks for patients with ACS treated by ultrathin biodegradable polymer sirolimus-eluting stents,” Jang said. – by Erik Swain
Reference:
Kim BK, et al. Late-Breaking Clinical Trials IV. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).
Disclosures: The trial was funded by Biotronik. Jang reports no relevant financial disclosures.
Perspective
Back to TopClaire Duvernoy, MD, FACC
This was a wonderfully done trial that adds to our expanding body of evidence for the newer, more potent P2Y12 inhibitors as monotherapy after PCI. This trial stands out because it was an all-ACS trial and, from what I can tell, the only such trial so far that had a significant population of patients with STEMI. The fact that there was no signal of harm in the STEMI subpopulation is very important.
The trial shows us that ticagrelor may have some special effects that we did not see with clopidogrel, although there were studies presented at ACC. 2019 that appeared favorable for clopidogrel monotherapy.
Because I see it in my practice, I wonder about discontinuation rates with ticagrelor. I see about 10% to 15% discontinuation because of dyspnea.
Also notable is that this trial used a second-generation drug-eluting stent. There may be a markedly increased safety signal with this second generation of DES that allows us to get away with monotherapy and, thereby, markedly reduce our bleeding risks.
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