Coronary disease & ACSRandomised controlled trial
Early Withdrawal of Aspirin after Percutaneous Coronary Intervention (PCI) in Acute Coronary Syndromes
- Randomised controlled trial
- multicentre
- open-label
- non-inferiority
Authors' conclusion
Among patients who had undergone successful PCI for acute coronary syndromes, potent P2Y12 inhibitor monotherapy was not found to be noninferior to dual antiplatelet therapy with respect to a composite of death or ischemic events at 12 months.
Study context
- Population
- Patients with ACS after successful PCI, BrazilITT population
- Participants
- 3,410 patients
- Comparison
- Potent P2Y12 inhibitor monotherapy vs DAPT
- Monotherapyn = 1,712
- Dual antiplatelet therapyn = 1,698reference
- Primary endpoint
- Two ranked primary outcomes: death from any cause, MI, stroke or urgent target-vessel revascularization (non-inferiority, margin 2.5 percentage points); major or clinically relevant nonmajor bleeding (superiority)
- Follow-up
- 12 months
Primary result
As reported in the abstract
Death from any cause, MI, stroke or urgent revascularization
Absolute risk difference
1.47 percentage points
95% CI −0.16 to 3.10
P = 0.11 for non-inferiority
Events by treatment group
Monotherapy vs DAPT
absolute risk difference 1.47 percentage points (95% CI −0.16 to 3.10); P for non-inferiority = 0.11
Further findings
| Outcome | Monotherapy | Dual antiplatelet therapy | absolute risk difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| Major or clinically relevant nonmajor bleeding (second ranked primary outcome) · 12 months · Kaplan-Meier estimates | 2.0% | Not reported in the abstract | −2.97 (−4.20 to −1.73) | |
| −6−4−202Difference, percentage points (linear scale) |
- Major or clinically relevant nonmajor bleeding (second ranked primary outcome): DAPT 4.9%
Safety
| Outcome | Monotherapy | Dual antiplatelet therapy | absolute risk difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| Major or clinically relevant nonmajor bleeding · 12 months | 2.0% | Not reported in the abstract | −2.97 (−4.20 to −1.73) | |
| −6−4−202Difference, percentage points (linear scale) |
| Outcome | Monotherapy | Dual antiplatelet therapy | Estimate |
|---|---|---|---|
| Stent thrombosis | 12 events | Not reported in the abstract |
- Major or clinically relevant nonmajor bleeding: DAPT 4.9%
- Stent thrombosis: DAPT 4 events
Original publication
Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes. N Engl J Med. Published 31 August 2025. doi:10.1056/nejmoa2507980
Summarised from the published abstract; every number is checked against it