- Question
- In patients with acute coronary syndrome treated with PCI and drug-eluting stents who remained event-free after one month of dual antiplatelet therapy, does ticagrelor monotherapy reduce clinically relevant bleeding without increasing major adverse cardiovascular and cerebrovascular events (MACCE) compared with ticagrelor plus aspirin?
- Design
- Randomized, double-blind, placebo-controlled trial including 3400 patients at 58 centres in China, Italy, Pakistan and the UK. Randomization used a web-based system with dynamic minimization; 12-month follow-up was completed in nearly all patients and analysis was by intention to treat.
- Population
- Patients aged 18 years or older with acute coronary syndrome treated with PCI using contemporary drug-eluting stents, who had no major ischaemic or bleeding events during the first month of dual antiplatelet therapy with ticagrelor and aspirin.
- Intervention
- Ticagrelor 90 mg twice daily plus a matching aspirin placebo, from month 1 to month 12 after PCI (11 months in total).
- Control
- Ticagrelor 90 mg twice daily plus aspirin 100 mg once daily over the same period.
- Primary outcome
- Co-primary superiority endpoint: clinically relevant bleeding (BARC types 2, 3 or 5). Co-primary non-inferiority endpoint: MACCE, a composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis or clinically driven target vessel revascularization, with an absolute non-inferiority margin of 2.5 percentage points. The endpoints were tested sequentially.
- Results
- Clinically relevant bleeding occurred in 35 patients (2.1%) with ticagrelor plus placebo and in 78 (4.6%) with ticagrelor plus aspirin (HR 0.45; 95% CI 0.30 to 0.66; p<0.0001). MACCE occurred in 61 patients (3.6%) vs 63 (3.7%) (absolute difference -0.1%; 95% CI -1.4% to 1.2%; HR 0.98; 95% CI 0.69 to 1.39; non-inferiority p<0.0001).
- Conclusion
- Between month 1 and month 12 after PCI, ticagrelor monotherapy reduced clinically relevant bleeding with a MACCE rate similar to that of ticagrelor plus aspirin.
- Why it matters
- It supports dropping aspirin after one month of dual antiplatelet therapy and continuing ticagrelor alone in most patients with acute coronary syndrome treated with PCI, lowering bleeding risk without losing ischaemic protection.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026