“ULTIMATE-DAPT” trial summary. It presents the results of a clinical trial comparing the use of ticagrelor alone versus the combination of ticagrelor and aspirin following percutaneous coronary intervention (PCI) in patients with Acute Coronary Syndrome (ACS) from month 1 to month 12 after the procedure. Here’s a detailed breakdown of the content:
- Study Type: A randomised, placebo-controlled, double-blind trial.
- Objective: To assess whether ticagrelor alone can reduce the incidence of clinically relevant bleeding events without an increase in major adverse cardiovascular or cerebrovascular events (MACCE).
- Inclusion Criteria: Patients 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and had no major ischemic or bleeding events after 1-month treatment with dual antiplatelet therapy.
- Participants: 3,400 patients were involved in the study.
- Half of them (1,700) were given oral ticagrelor plus oral aspirin.
- The other half (1,700) were given oral ticagrelor plus a placebo.
- Primary Outcomes:
- Clinically relevant bleeding at one year was 4.6% in the ticagrelor plus aspirin group and 2.1% in the ticagrelor plus placebo group. The Hazard Ratio (HR) for bleeding was 0.45 with a 95% Confidence Interval (CI) from 0.30 to 0.66 (P<0.0001), indicating a significant reduction in bleeding with ticagrelor alone.
- The composite of MACCE events was 3.7% in the ticagrelor plus aspirin group and 3.6% in the ticagrelor plus placebo group, with an HR of 0.98 and a 95% CI from 0.69 to 1.39. The P-value for noninferiority was <0.0001, and the P-value for superiority was 0.89, suggesting that ticagrelor alone was not inferior to the combination therapy in preventing MACCE.
- Secondary Outcome:
- Net adverse clinical events (which includes MACCE or BARC types 1-5 bleeding) occurred in 8.2% of the combination therapy group versus 5.7% of the ticagrelor plus placebo group (P=0.007), indicating a statistically significant difference favoring ticagrelor alone.
- Conclusion: For patients with acute coronary syndrome who had a PCI with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin.
Zhen Ge et al. THE LANCET 2024; DOI:https://doi.org/10.1016/S0140-6736(24)00473-2