What question did this study set out to answer?

The study aims to evaluate whether early aspirin withdrawal improves safety outcomes compared to continued dual antiplatelet therapy in high-risk patients after PCI.

March 28, 2026Open Access

Early aspirin withdrawal versus dual antiplatelet therapy in high-risk patients after percutaneous coronary intervention: Meta-analysis of randomized trials

Key Result

Early aspirin withdrawal (≤3 months) with P2Y12-inhibitor monotherapy reduced bleeding (HR 0.55) without increasing myocardial infarction compared to continued DAPT in high-risk post-PCI patients.

Key Points

The study aims to evaluate whether early aspirin withdrawal improves safety outcomes compared to continued dual antiplatelet therapy in high-risk patients after PCI.
Conducted a meta-analysis of randomized trials up to August 2025.
Compared early aspirin withdrawal with P2Y12-inhibitor monotherapy against continued DAPT.
Co-primary outcomes were rates of myocardial infarction and clinically relevant bleeding.
P2Y12-inhibitor monotherapy significantly reduced bleeding risk without increasing overall myocardial infarction rates.
Immediate aspirin withdrawal raised the risk of myocardial infarction, while early discontinuation showed no significant difference.
TSA indicated a clear benefit for reducing bleeding and no excess risk for myocardial infarction with early withdrawal.

Structured PICO

Does early aspirin withdrawal with transition to ticagrelor- or prasugrel-monotherapy reduce bleeding and prevent MI in high-risk patients after PCI compared to continued DAPT?

Population

High-risk patients after percutaneous coronary intervention (PCI)

Intervention

Early aspirin withdrawal (≤3 months) with transition to ticagrelor- or prasugrel-monotherapy

Comparator

Continued dual antiplatelet therapy (DAPT)

Outcome

Co-primary outcomes: myocardial infarction (MI) and clinically relevant bleedinghard clinical

In high-risk patients post-PCI, discontinuing aspirin within 3 months and continuing P2Y12-inhibitor monotherapy significantly reduces bleeding without increasing ischemic events, though immediate aspirin cessation should be avoided.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Background Patients at high ischemic or bleeding risk after percutaneous coronary intervention (PCI) require protection against thrombotic events with dual antiplatelet therapy (DAPT) while avoiding bleeding. Although guidelines recommend 12-month DAPT after acute coronary syndrome (ACS), recent trials have tested the safety of early aspirin withdrawal with potent P2Y12-inhibitor monotherapy. Methods and findings We performed a meta-analysis of randomized trials (from inception through August 2025) comparing early aspirin withdrawal (≤3 months) with transition to ticagrelor- or prasugrel-monotherapy versus continued DAPT. Co-primary outcomes were myocardial infarction (MI) and clinically relevant bleeding. Prespecified timing analyses stratified the comparison versus DAPT by aspirin timing: immediate (aspirin noninitiation or in-hospital cessation) and early (post-discharge discontinuation within 3 months). Bayesian models quantified risk-stratified probabilities of benefit and harm; trial sequential analysis (TSA) assessed conclusiveness of evidence. Seven trials ( n = 27,743) were included. P2Y12-inhibitor monotherapy reduced bleeding (HR = 0.55, 95% CI 0.42, 0.71; p < 0.001) without significantly increasing MI overall (HR = 1.11, 95% CI 0.91, 1.35; p = 0.31), death, stroke, or stent thrombosis. Immediate aspirin noninitiation/cessation increased MI (HR = 1.41, 95% CI 1.01, 1.97; p = 0.04), whereas early discontinuation did not (HR = 0.97, 95% CI 0.76, 1.24; p = 0.82). TSA indicated conclusiveness for bleeding benefit and futility for an MI excess. Analyses restricted to ACS confirmed the overall results. Bayesian analyses corroborated these effects and identified risk-aligned timing: in high bleeding risk, ≤1-month aspirin discontinuation yielded a 100% posterior probability of bleeding benefit (NNT = 12) and 70% probability of MI-safety; in high ischemic risk, 3-month aspirin discontinuation yielded 100% probability of bleeding benefit (NNT = 57) and 86% probability of MI-safety. Limitations include aggregate data only and limited precision for the immediate aspirin withdrawal subgroup. Conclusions Among high-risk post-PCI patients on ticagrelor/prasugrel, discontinuing aspirin within 3 months reduces bleeding without an ischemic trade-off versus DAPT. Immediate aspirin noninitiation or cessation should be avoided; timing should be individualized to bleeding and ischemic risk. PROSPERO: CRD420251167706.