Early withdrawal of aspirin in favour of potent P2Y12 inhibitor monotherapy following percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) did not meet the criteria for noninferiority for preventing ischaemic events compared to standard dual antiplatelet therapy (DAPT), according to results from the NEO-MINDSET trial.¹˒²

The NEO-MINDSET trial was a multicentre, open-label, randomised study conducted in Brazil. It included 3,410 patients with ACS who had undergone successful PCI. Within the first four days of hospitalisation, patients were assigned in a 1:1 ratio to either stop aspirin and receive potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) or to continue with DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months.

The two ranked primary outcomes were assessed at 12 months. The first was a composite of death from any cause, myocardial infarction, stroke, or urgent target-vessel revascularisation, which was tested for noninferiority with a margin of 2.5 percentage points. The second was major or clinically relevant nonmajor bleeding, tested for superiority.

The primary ischaemic outcome occurred in 119 patients (7.0%) in the monotherapy group and 93 patients (5.5%) in the DAPT group. The absolute risk difference was 1.47 percentage points (95% CI, -0.16 to 3.10), which did not meet the pre-specified criteria for noninferiority (p=0.11).

For the primary bleeding outcome, monotherapy was found to be superior to DAPT. Major or clinically relevant nonmajor bleeding occurred in 33 patients (2.0%) in the monotherapy group compared to 82 patients (4.9%) in the DAPT group (absolute risk difference, -2.97 percentage points; 95% CI, -4.20 to -1.73).

Notably, stent thrombosis was observed more frequently in the monotherapy arm, occurring in 12 patients compared to four in the DAPT arm.

These findings suggest that while early aspirin withdrawal reduces bleeding risk, it may not provide equivalent protection against ischaemic events. The NEO-MINDSET Trial Investigators concluded that among patients who had undergone successful PCI for ACS, “potent P2Y12 inhibitor monotherapy was not found to be noninferior to dual antiplatelet therapy with respect to a composite of death or ischemic events at 12 months.”¹ The increased incidence of stent thrombosis with monotherapy further underscores the potential ischaemic risk associated with this strategy in the ACS population.

References

1. Guimarães PO, Franken M, Tavares CAM, et al. Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes. N Engl J Med 2025;393:2095-2106. https://doi.org/10.1056/NEJMoa2507980

2. Leopold JA. Discontinuation of Aspirin in Acute Coronary Syndromes Treated with Coronary-Artery Stents. N Engl J Med 2025;393:2164-2166. https://doi.org/10.1056/NEJMe2516148

This study was funded by the Brazilian Ministry of Health.

Disclaimer: The information presented in this article is for educational purposes only. Any quotes included reflect the opinions of the individual quoted, and do not necessarily reflect the views of the publisher. The publisher does not guarantee the accuracy or completeness of the content and accepts no responsibility for any errors, or any consequences arising from its use.