Aspirin Omission at the Time of Primary Percutaneous Coronary Intervention in STEMI
In brief
Aspirin-free prasugrel after STEMI PCI raises ischemic events but halves bleeding
In a randomized trial of 2,216 STEMI patients, prasugrel alone before primary PCI resulted in a 12-month composite of death, stroke or MI in 11% of patients versus 8.5% with aspirin-prasugrel, while major bleeding fell to 5.6% compared with 8.4% on dual therapy. The strategy did not meet non-inferiority for ischemic protection, leaving clinicians to weigh the modest bleed reduction against higher event rates.
- Journal
- The New England journal of medicine (Q1)
- Published
- 29 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Kuniaki Takahashi, Ken Kozuma, Yoshihiro Morino, Kosuke Kashiwabara, Hiromasa Otake, Satoru Suwa, et al.
- PMID
- 42670955
- DOI
- 10.1056/NEJMoa2606997
Why clinicians should know about it
- Picked for Cardiology and Cardiovascular Medicine (paper of the day, 3 September 2026): RCT of aspirin omission vs DAPT in STEMI
Abstract
BACKGROUND: The safety of omitting up-front treatment with aspirin during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear. METHODS: We conducted a multicenter, open-label, randomized trial in Japan involving patients with STEMI who were undergoing primary PCI. Patients were randomly assigned in a 1:1 ratio before PCI to receive low-dose prasugrel monotherapy or dual antiplatelet therapy (DAPT) with aspirin and low-dose prasugrel for 12 months. The primary outcome was a composite of death from any cause, stroke, or myocardial infarction at 12 months, which was assessed for noninferiority with a prespecified noninferiority margin of 1.50 for the 95% confidence interval of the hazard ratio. The major secondary outcome was major bleeding (defined as a bleeding event of Bleeding Academic Research Consortium [BARC] type 3 [nonfatal major bleeding] or 5 [fatal bleeding]) at 12 months, which was assessed for superiority if noninferiority was established for the primary outcome. RESULTS: A total of 2216 patients were included in the full analysis population; 1109 were assigned to receive monotherapy and 1107 to receive DAPT. At 12 months, death from any cause, stroke, or myocardial infarction had occurred in 124 patients (Kaplan-Meier estimate, 11.0%) in the monotherapy group and in 94 patients (Kaplan-Meier estimate, 8.5%) in the DAPT group (hazard ratio, 1.34; 95% confidence interval [CI], 1.02 to 1.75; P = 0.40 for noninferiority). Major bleeding had occurred in 61 patients (Kaplan-Meier estimate, 5.6%) in the monotherapy group and in 92 patients (Kaplan-Meier estimate, 8.4%) in the DAPT group (hazard ratio, 0.66; 95% CI, 0.47 to 0.91). The percentages of patients with definite or probable stent thrombosis and serious adverse events appeared to be similar in the two groups. CONCLUSIONS: Among patients with STEMI who were undergoing primary PCI, low-dose prasugrel monotherapy initiated before PCI was not noninferior to DAPT for 12 months with respect to a composite of death from any cause, stroke, or myocardial infarction at 12 months. (Funded by Boston Scientific Japan; PREMIUM ClinicalTrials.gov number, NCT05709626.).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.