Key result
Early aspirin withdrawal cuts post-PCI bleeding ~47% without increasing MACE vs 12-month DAPT.
Why the study?
Prior meta-analyses after PCI for ACS predominantly evaluated shortened DAPT rather than aspirin-free strategies, leaving the net impact of early aspirin discontinuation with P2Y12 inhibitor monotherapy on ischemic and bleeding outcomes uncertain.
Does early aspirin withdrawal followed by P2Y12 inhibitor monotherapy reduce major adverse cardiovascular events and clinically relevant bleeding compared to standard 12-month DAPT in adults with ACS undergoing PCI?
Meta-Analysis (n=34,283)
Does early aspirin withdrawal followed by P2Y12 inhibitor monotherapy reduce major adverse cardiovascular events and clinically relevant bleeding compared to standard 12-month DAPT in adults with ACS undergoing PCI?
Early aspirin discontinuation with continuation of P2Y12 inhibitor monotherapy after PCI for ACS significantly reduces major and clinically relevant bleeding as well as net adverse clinical events without increasing ischemic MACE compared to standard 12-month DAPT.
Supports early aspirin withdrawal after ACS PCI to reduce bleeding; extends prior DAPT de-escalation evidence to aspirin-free regimens.
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.
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Saffi et al. (2026) conducted a meta-analysis in Acute coronary syndromes undergoing percutaneous coronary intervention (n=34,283). Early aspirin withdrawal followed by P2Y12 inhibitor monotherapy vs. Standard 12-month dual antiplatelet therapy (DAPT) was evaluated on Major adverse cardiovascular events (all-cause death, myocardial infarction, stroke, or urgent/unplanned revascularization) (RR 1.01, 95% CI 0.85-1.22, p=0.874). Early aspirin withdrawal to P2Y12 monotherapy after PCI for ACS reduced clinically relevant bleeding (RR 0.53; 95% CI 0.47-0.60) without increasing MACE (RR 1.01; 95% CI 0.85-1.22) vs 12-month DAPT.
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