Early aspirin withdrawal to P2Y12 monotherapy after PCI for ACS: a systematic review and meta-analysis of randomized controlled trials
M Saffi, L D Spaeth, A Perez, L Dexheimer da Silva, A C VitorinoAbstract
Background
Early aspirin discontinuation with continuation of P2Y12 inhibitor monotherapy has been proposed to reduce bleeding after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). However, prior meta-analyses predominantly assessed shortened dual antiplatelet therapy (DAPT) rather than aspirin-free strategies, and the net impact on ischemic and bleeding outcomes in ACS remains uncertain.
Purpose
To assess the safety and efficacy of early aspirin withdrawal with continued P2Y12 inhibitor monotherapy compared with standard 12-month DAPT by assessing major adverse cardiovascular events (MACE) and major or clinically relevant bleeding.
Methods
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) enrolling adults with ACS undergoing PCI, comparing early aspirin withdrawal followed by P2Y12 inhibitor monotherapy versus standard 12-month DAPT. PubMed, Embase, and the Cochrane Library were searched through February 2026. The primary efficacy outcome was MACE (all-cause death, myocardial infarction, stroke, or urgent/unplanned revascularization), and the primary safety outcome was clinically relevant bleeding (BARC 2–5 or ISTH major). Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model. Analyses were performed with Review Manager version 10.0.1.
Results
Of 3,019 records screened, 11 RCTs comprising 34,283 patients were included. Early aspirin withdrawal was not associated with a significant difference in MACE compared with standard DAPT (RR 1.01; 95% CI 0.85–1.22; p=0.874; I²=48.3%; Figure 1). However, early aspirin discontinuation significantly reduced clinically relevant bleeding (BARC 2–5) (RR 0.53; 95% CI 0.47–0.60; p<0.001; I²=0%; Figure 2A) and major bleeding (RR 0.54; 95% CI 0.43–0.66; p<0.001; I²=42.7%; Figure 2B). Accordingly, net adverse clinical events (NACE) were significantly lower in the early withdrawal group (RR 0.73; 95% CI 0.64–0.84; p<0.001; I²=44.0%; Figure 2C).
Conclusions
In this meta-analysis of RCTs, early aspirin discontinuation with continuation of P2Y12 inhibitor monotherapy reduced major bleeding and NACE without increasing MACE compared with standard 12-month DAPT.Figure 1.Figure2