Visual Abstract Summary for the STOPDAPT-2 ACS Trial
Question
Is 1–2 months of dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy noninferior to 12 months of DAPT with aspirin and clopidogrel in patients with acute coronary syndromes (ACS)?
Design
- Trial Type: Multicenter, open-label, randomized clinical trial.
- Population: 4,136 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents across 96 centers in Japan.
- 1–2 months DAPT group: 2,078 patients.
- 12 months DAPT group: 2,091 patients.
- Follow-up: 1 year.
Key Outcomes
- Primary Endpoint:
- Composite of cardiovascular (CV) and bleeding events at 12 months.
- 1–2 months DAPT group: 3.2% (65/2058 patients).
- 12 months DAPT group: 2.8% (58/2057 patients).
- Result: Noninferiority not achieved (HR 1.14, 95% CI 0.80–1.62; P = .06).
- Composite of cardiovascular (CV) and bleeding events at 12 months.
- Major Secondary Endpoints:
- Cardiovascular Events (CV death, MI, stroke, stent thrombosis):
- 1–2 months DAPT group: 2.8%.
- 12 months DAPT group: 1.9%.
- Result: HR 1.50, 95% CI 0.99–2.26 (increased CV risk).
- Bleeding Events (TIMI major/minor bleeding):
- 1–2 months DAPT group: 0.5%.
- 12 months DAPT group: 1.2%.
- Result: HR 0.46, 95% CI 0.23–0.94 (reduced bleeding risk).
- Cardiovascular Events (CV death, MI, stroke, stent thrombosis):
Key Findings
- 1–2 months of DAPT followed by clopidogrel monotherapy did not achieve noninferiority to 12 months of DAPT for net clinical outcomes.
- Increased CV events were observed in the 1–2 months DAPT group despite a reduction in bleeding events.
Conclusion
- The effectiveness of short-term DAPT followed by clopidogrel monotherapy remains inconclusive.
- While bleeding risk is reduced, the numerical increase in CV events underscores the need for further clinical trials to determine the optimal antiplatelet therapy for ACS patients after PCI.