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Randomised controlled trial

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

LancetPublished

  • Randomised controlled trial
  • placebo-controlled
  • double-blind
  • multicentre (58 centres in China, Italy, Pakistan, UK)
  • co-primary endpoints tested sequentially
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Authors' conclusion

In patients with an acute coronary syndrome who had percutaneous coronary intervention 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.

Study context

Population
Patients ≥18 years with ACS after PCI with contemporary drug-eluting stents, event-free after 1 month of DAPT (IVUS-ACS participants)3,399 completed 12-month follow-up
Participants
3,400 patients
Comparison
Ticagrelor plus placebo vs Ticagrelor plus aspirin
  • Ticagrelor plus placebon = 1,700
  • Ticagrelor plus aspirinn = 1,700reference
Primary endpoint
Co-primary: clinically relevant bleeding (BARC types 2, 3, or 5; superiority) and MACCE (cardiac death, MI, ischaemic stroke, definite stent thrombosis or clinically driven target vessel revascularisation; non-inferiority, absolute margin 2.5 percentage points)
Follow-up
Between month 1 and month 12 after PCI

Primary result

As reported in the abstract

Clinically relevant bleeding (BARC 2, 3 or 5) and MACCE · month 1 to month 12 after PCI

Ticagrelor plus placebo

35 (2.1%)

Clinically relevant bleeding · MACCE 61 (3.6%)

Ticagrelor plus aspirin

78 (4.6%)

Clinically relevant bleeding · MACCE 63 (3.7%)

Ticagrelor plus placebo vs Ticagrelor plus aspirinHazard ratio (95% CI)P value
clinically relevant bleeding (superiority)
0.45(0.30–0.66)
P < 0.0001
MACCE
0.98(0.69–1.39)
P = 0.89for superiority

Non-inferiority margin 2.5 as printed, not drawn

Ticagrelor plus placebo vs Ticagrelor plus aspirinAbsolute difference, % (95% CI)P value
MACCE (non-inferiority)
−0.1(−1.4% to 1.2%)
P < 0.0001for non-inferiority

Non-inferiority margin 2.5 as printed, not drawn

Safety

OutcomeTicagrelor plus placeboTicagrelor plus aspirinHR (95% CI)P value
Clinically relevant bleeding (BARC 2, 3 or 5) · month 1 to month 12 after PCI2.1%4.6%0.45 (0.30–0.66)P < 0.0001

Original publication

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. Published 7 April 2024. doi:10.1016/s0140-6736(24)00473-2
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Summarised from the published abstract; every number is checked against it