- Question
- Can early antiplatelet de-escalation from prasugrel to clopidogrel, guided by platelet function testing, preserve efficacy while reducing bleeding after an acute coronary syndrome treated with PCI?
- Design
- Randomised 1:1, open-label, assessor-blinded, multicentre trial at 33 sites in Europe, with 2610 patients assigned. The primary hypothesis was non-inferiority with a 30% margin, and analysis was by intention to treat.
- Population
- Patients with biomarker-positive acute coronary syndrome, successful PCI, and a planned 12-month duration of dual antiplatelet therapy.
- Intervention
- Step-down regimen: prasugrel for 1 week, then clopidogrel for 1 week, and from day 14 after discharge maintenance therapy with clopidogrel or prasugrel according to platelet function testing.
- Control
- Standard treatment with prasugrel for 12 months.
- Primary outcome
- Net clinical benefit at 1 year: composite of cardiovascular death, myocardial infarction, stroke, or bleeding BARC grade 2 or higher.
- Results
- The primary endpoint occurred in 95 patients (7%) in the de-escalation group and 118 (9%) in the control group (non-inferiority p=0.0004; HR 0.81; 95% CI 0.62-1.06; superiority p=0.12). The composite of cardiovascular death, myocardial infarction, or stroke occurred in 32 patients (3%) versus 42 (3%) (non-inferiority p=0.0115).
- Safety
- There were 64 BARC 2 or higher bleeding events (5%) in the de-escalation group versus 79 (6%) in the control group (HR 0.82; 95% CI 0.59-1.13; p=0.23).
- Conclusion
- Guided de-escalation was non-inferior to standard prasugrel treatment for net clinical benefit at 1 year, without demonstrated superiority.
- Why it matters
- It showed that reducing antiplatelet potency early and in a guided manner can be a reasonable alternative after an acute coronary syndrome managed with PCI, 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 14, 2026