STOPDAPT-3 Trial
Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-3
Design:
- An open label, parallel, randomized trial
Objective:
- To compare the safety and efficacy of an aspirin-free strategy among patients undergoing percutaneous coronary intervention (PCI) or at high bleeding risk.
Patients:
- 5,966 patients
Inclusion criteria:
- High bleeding risk or acute coronary syndrome
- Planned to have PCI with everolimus-eluting stent
- Could take dual antiplatelet therapy (DAPT) with aspirin and P2Y12 inhibitors for 1 month
Exclusion criteria:
- Contraindication to antiplatelet drugs
Comparison:
- Prasugrel monotherapy (3.75 mg/day) (n = 2,984)
- Versus
- Aspirin (81-100 mg/day) + Prasugrel (3.75 mg/day) (n = 2,982)
Primary Outcomes:
- Major bleeding events %
- Prasugrel: 4.47%
- Aspirin + Prasugrel: 4.71%
- HR: 0.95, 95% CI: 0.75-1.20 (P = 0.66)
- Cardiovascular endpoint at 1 month %
- Prasugrel: 4.12%
- Aspirin + Prasugrel: 3.69%
- HR: 1.12, 95% CI: 0.87-1.45 (P = 0.01)
Secondary Outcomes:
- Any unplanned coronary revascularization %
- Prasugrel: 1.05%
- Aspirin + Prasugrel: 0.57%
- HR: 1.83, 95% CI: 1.01-3.30 (P < 0.05)
- Subacute definite or probable stent thrombosis %
- Prasugrel: 0.58%
- Aspirin + Prasugrel: 0.17%
- HR: 3.40, 95% CI: 1.26-9.23 (P < 0.05)
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.
Reference:
- Natsuaki M et al. Circulation 2024;149:585-600
This data highlights the key points of the STOPDAPT-3 trial, comparing the outcomes of prasugrel monotherapy against a combination of aspirin and prasugrel in patients with high bleeding risk or acute coronary syndrome undergoing PCI.