Coronary disease & ACSRandomised controlled trial
Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction
- Randomised controlled trial
- multicentre
- open-label
- non-inferiority
- 40 European sites
Authors' conclusion
Among low-risk patients with acute myocardial infarction who had undergone early complete revascularization and had completed 1 month of dual antiplatelet therapy without complications, P2Y12-inhibitor monotherapy was noninferior to continued dual antiplatelet therapy with respect to the occurrence of adverse cardiovascular and cerebrovascular events and resulted in a lower incidence of bleeding events.
Study context
- Population
- Adults with acute MI after successful complete revascularization within 7 days who completed 1 month of DAPT with no ischemic or major bleeding events2,246 enrolled
- Participants
- 1,942 adults
- Comparison
- P2Y12-inhibitor monotherapy vs continued DAPT after 1 month of DAPT
- P2Y12-inhibitor monotherapyn = 961
- Dual antiplatelet therapyn = 981reference
- Primary endpoint
- Death from any cause, MI, stent thrombosis, stroke, or major bleeding (BARC type 3 or 5)
- Follow-up
- 11 months after randomization
Primary result
As reported in the abstract
Difference
−0.09 percentage points
95% CI −1.39 to 1.20
P = 0.02 for non-inferiority
Events by treatment group
P2Y12-inhibitor monotherapy vs DAPT
difference −0.09 percentage points (95% CI −1.39 to 1.20); P for non-inferiority = 0.02
Secondary outcomes
| Outcome | P2Y12-inhibitor monotherapy | Dual antiplatelet therapy | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| BARC type 2, 3, or 5 bleeding (main secondary outcome) · 11 months after randomization | 2.6% | Not reported in the abstract | 0.46 (0.29–0.75) | P for superiority = 0.002 | |
| 0.20.5125Hazard ratio (log scale) |
- BARC type 2, 3, or 5 bleeding (main secondary outcome): DAPT 5.6%
Stent thrombosis
- Infrequent, incidence similar in the two groups
Safety
Serious adverse events
- Incidence appeared to be similar in the two groups
Original publication
Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction. N Engl J Med. Published 31 August 2025. doi:10.1056/nejmoa2508808
Summarised from the published abstract; every number is checked against it