Coronary disease & ACSRandomised controlled trial
An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial
- Randomised controlled trial
- non-inferiority (coprimary CV end point, relative 50% margin)
Adherence to protocol antiplatelet therapy 88% in both groups at 1 month
Authors' conclusion
The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events.
Study context
- Population
- Patients with ACS or high bleeding risk undergoing percutaneous coronary intervention (PCI)5,966 in full analysis set
- Participants
- 6,002 patients
- Comparison
- Aspirin-free prasugrel monotherapy vs dual antiplatelet therapy (DAPT) with aspirin and prasugrel
- No-aspirinn = 2,984
- DAPTn = 2,982reference
- Primary endpoint
- Coprimary: major bleeding (BARC 3 or 5) for superiority; CV events (CV death, MI, definite stent thrombosis or ischemic stroke) for noninferiority
- Follow-up
- 1 month
Primary result
As reported in the abstract
No-aspirin
4.47%
Major bleeding · CV events 4.12%
DAPT
4.71%
Major bleeding · CV events 3.69%
No-aspirin vs DAPTHazard ratio (95% CI)P value
major bleeding; not superior
0.95(0.75–1.20)
P = 0.66for superiorityCV events; noninferior
1.12(0.87–1.45)
P = 0.01for non-inferiorityFurther findings
Net adverse clinical outcomes and each component of coprimary CV end point
- No difference
Safety
| Outcome | No-aspirin | DAPT | HR (95% CI) | |
|---|---|---|---|---|
| Any unplanned coronary revascularization | 1.05% | 0.57% | 1.83 (1.01–3.30) | |
| Subacute definite or probable stent thrombosis | 0.58% | 0.17% | 3.40 (1.26–9.23) | |
| 0.10.31310Hazard ratio (log scale) |
Original publication
An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial. Circulation. Published 23 November 2023. doi:10.1161/circulationaha.123.066720
Summarised from the published abstract; every number is checked against it