The ULTIMATE-DAPT (One-Month Ticagrelor Monotherapy After PCI in Acute Coronary Syndromes) trial data demonstrated that, in patients with acute coronary syndrome who underwent percutaneous coronary intervention and remained event-free after 1 month of dual antiplatelet therapy (DAPT), ticagrelor monotherapy (month 1 to month 12) resulted in lower bleeding events and similar rates of major adverse cardiovascular or cerebrovascular events (MACCE) compared with DAPT (ticagrelor plus aspirin) for 12 months.¹

The ULTIMATE-DAPT trial investigators enrolled 3,400 patients (1,700 to ticagrelor plus aspirin and 1,700 to ticagrelor plus placebo) from 58 clinical sites across China, Pakistan, the United Kingdom, and Italy. The findings showed that the primary endpoint of clinically relevant bleeding (Bleeding Academic Research Consortium [BARC] type 2, 3, or 5) occurred in 2.1% in those treated with ticagrelor plus placebo versus 4.6% in those treated with ticagrelor plus aspirin (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.3-0.66; p < 0.0001). The composite endpoint of MACCE showed no difference between the ticagrelor plus placebo and ticagrelor plus aspirin (3.6% vs. 3.7%; HR, 0.98; 95% CI, 0.69-1.39; pnoninferiority < 0.0001; psuperiority = 0.89). Additionally, there was no difference in all-cause mortality (0.7% vs. 0.8%; p = 0.84), nonprocedural myocardial infarction (0.9% vs. 0.7%; p = 0.29), repeat revascularization (2.4% vs. 2.4%; p = 0.95), or stent thrombosis (0.3% vs. 0.3%; p = 0.96).

The ULTIMATE-DAPT trial data showed that, after 1 month of DAPT (aspirin plus ticagrelor), ticagrelor monotherapy reduced bleeding risk without increasing MACCE risk. Previous studies had similar findings: the TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) and T-PASS (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome) trials.^2,3 Contrary to previous studies, this study was placebo controlled, not open label. The ULTIMATE-DAPT trial's limitations included the small percentage of women participants (26%) and the limitations of generalizability to other ethnicities (98.7% of patients were from China and Pakistan). More trials are needed to determine whether prasugrel offers a similar benefit.

References

1. Ge Z, Kan J, Gao X, et al.; ULTIMATE-DAPT Investigators. Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial. Lancet 2024;403:1866-78.
2. Kim BK, Hong SJ, Cho YH, et al.; TICO Investigators. Effect of ticagrelor monotherapy vs ticagrelor with aspirin on major bleeding and cardiovascular events in patients with acute coronary syndrome: the TICO randomized clinical trial. JAMA 2020;323:2407-16.
3. Hong SJ, Lee SJ, Suh Y, et al.; T-PASS (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome) Investigators. Stopping aspirin within 1 month after stenting for ticagrelor monotherapy in acute coronary syndrome: the T-PASS randomized noninferiority trial. Circulation 2024;149:562-73.