Early aspirin withdrawal versus dual antiplatelet therapy in high-risk patients after percutaneous coronary intervention: Meta-analysis of randomized trials
In high-risk stent patients, stopping aspirin after discharge reduced bleeding without more heart attacks.
*Meta-analysis of randomized trials; Level 1a.
Citation
Navarese EP, Gurbel P, Tantry U, et al. PLoS Medicine. 2026;23(3):e1004995. doi:10.1371/journal.pmed.1004995
Background
After coronary stenting, two antiplatelet medicines lower clot risk but increase bleeding. The safest timing for aspirin withdrawal in higher-risk patients has been uncertain.
Patients
27,743 adults in 7 randomized trials after coronary stenting, at high clotting or bleeding risk. Excluded were trials not limited to high-risk patients, clopidogrel-only strategies, nonrandomized designs, confounded medication changes, or nonstandard stents.
Intervention
Aspirin not started or stopped in hospital, or stopped within 3 months, with ticagrelor or prasugrel alone.
Control
Continued aspirin plus ticagrelor or prasugrel.
Outcome
Co-primary outcomes: heart attack and clinically relevant bleeding using the Bleeding Academic Research Consortium scale (0–5).
Follow-up Period
Mostly 12 months; one trial contributed 30-day data.
Results
| Significant outcome | Comparison | Effect | Absolute impact |
|---|---|---|---|
| Clinically relevant bleeding | Aspirin stopped ≤3 months | Hazard ratio 0.55 | 3.80% vs 6.05%; number needed to treat 45 |
| Major bleeding | Early aspirin withdrawal trials | Hazard ratio 0.48 | 1.02% vs 2.14%; number needed to treat 90 |
| Heart attack | Immediate aspirin nonuse or in-hospital stop | Hazard ratio 1.41 | Harm signal |
Overall heart attack, death, stroke, and stent clot rates did not significantly differ. Analyses used intention-to-treat trial data. Continued two-drug therapy is current standard for many acute coronary syndrome patients.
Limitations
Used published summary data, not individual patient data. Only two trials tested immediate withdrawal. Bleeding results varied across studies, and several trials were open-label.
Funding
No specific funding; several authors reported industry ties.
Clinical Application
For high-risk stent patients on ticagrelor or prasugrel, consider stopping aspirin at 1–3 months; avoid immediate cessation and clopidogrel extrapolation.
Discussion
Sign in to join the discussion.
In this meta-analysis of 7 randomized trials after PCI, early aspirin withdrawal with ticagrelor/prasugrel monotherapy reduced bleeding (HR 0.55; 3.80% vs 6.05%) without higher overall MI (HR 1.11), but immediate withdrawal increased MI (HR 1.41); is this valid and applicable enough to change your DAPT practice? In this meta-analysis, clinically relevant bleeding occurred in 3.80% with P2Y12-inhibitor monotherapy versus 6.05% with continued DAPT, with HR 0.55. What is the best interpretation of the HR?