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
An erratum to this article was published (Lancet, 11 May 2024 ↗)
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
Methodological detailsplacebo-controlled, double-blind, multicentre (58 centres in China, Italy, Pakistan, UK), co-primary endpoints tested sequentially
- Placebo-controlled
- Double-blind
- Multicentre (58 centres in China, Italy, Pakistan, UK)
- Co-primary endpoints tested sequentially
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
- Clinically relevant bleeding
- 35 (2.1%)
- MACCE
- 61 (3.6%)
Ticagrelor plus aspirin
- Clinically relevant bleeding
- 78 (4.6%)
- MACCE
- 63 (3.7%)
Clinically relevant bleeding
Ticagrelor plus placebo35 (2.1%)
Ticagrelor plus aspirin78 (4.6%)
MACCE
Ticagrelor plus placebo61 (3.6%)
Ticagrelor plus aspirin63 (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 < 0.0001MACCE
0.98(0.69–1.39)
P = 0.89for superiorityNon-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-inferioritySafety
| Outcome | Ticagrelor plus placebo | Ticagrelor plus aspirin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Clinically relevant bleeding (BARC 2, 3 or 5) · month 1 to month 12 after PCI | 2.1% | 4.6% | 0.45 (0.30–0.66) | P < 0.0001 | |
| 0.20.5125Hazard ratio (log scale) |
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.
Summarised from the published abstract; every number is checked against it