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Noninferiority was not demonstrated for dying and ischemic occasions between P2Y12 inhibitor monotherapy and twin antiplatelet remedy (DAPT) given for 12 months after stenting in sufferers with acute coronary syndromes (ACS), in response to late-breaking analysis introduced in a Scorching Line session on the ESC Congress 2025 and concurrently revealed within the New England Journal of Drugs.
DAPT consisting of aspirin plus a potent P2Y12 inhibitor for 12 months is really useful for sufferers with ACS (myocardial infarction [MI] and unstable angina) after percutaneous coronary intervention (PCI) with stent implantation.
“Recent evidence suggests that withdrawal of aspirin after one to three months of DAPT, followed by P2Y12 inhibitor monotherapy may reduce bleeding while preventing recurrent ischemic events compared with 12 months of DAPT,” famous Principal Investigator, Professor Pedro Lemos from the Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
“We conducted the NEO-MINDSET trial to specifically investigate if P2Y12 inhibitor monotherapy could be used in the early phase, immediately after PCI and for the entire 12 months compared with DAPT for 12 months.”
The open-label randomized managed NEO-MINDSET trial was performed throughout 50 websites in Brazil. Sufferers with ACS present process profitable PCI with drug-eluting stents have been randomized 1:1 throughout the first 4 days of hospitalization to cease aspirin and obtain potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) or to DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months.
The primary major final result was a composite of dying, MI, stroke or pressing target-vessel coronary revascularization, with an absolute threat distinction of two.5 share factors set because the prespecified noninferiority margin. The second major final result was main or clinically related nonmajor bleeding, with superiority testing if the primary major final result was noninferior.
The evaluation inhabitants included 3,410 randomized sufferers who had a imply age of 59.6 years, with 29.3% being ladies.
The ischemic major endpoint occurred in 7.0% of sufferers within the monotherapy group and 5.5% within the DAPT group (hazard ratio [HR] 1.28; 95% confidence interval [CI], 0.98 to 1.68), leading to an absolute threat distinction of +1.47 share factors (95% CI, −0.16 to three.10), which didn’t meet the prespecified standards for noninferiority (p=0.11).
Main or clinically related nonmajor bleeding occurred in 2.0% of sufferers within the monotherapy group and 4.9% within the DAPT group (threat distinction −2.97 share factors; 95% CI −4.20 to −1.73).
The incidence of all-cause dying was 3.6% within the monotherapy group and three.0% within the DAPT group (HR 1.24; 95% CI 0.85 to 1.79). Any bleeding occurred in 4.5% of sufferers within the monotherapy group and 9.0% within the DAPT group.
A landmark evaluation on the ischemic major endpoint revealed a threat distinction of +1.5 share factors in the course of the first 30 days and 0.0 share factors from 30 days to 12 months for P2Y12 inhibitor monotherapy vs. DAPT. For the bleeding major endpoint, the danger distinction was −0.8 share factors in the course of the first 30 days and −2.2 share factors from 30 days to 12 months for monotherapy vs. DAPT.
Summarizing the findings, Professor Lemos concluded, “We didn’t reveal the noninferiority of aspirin-free monotherapy initiated instantly after PCI with regard to the ischemic major endpoint over 12 months.
“Results from the landmark analysis suggest that the excess ischemic risk with monotherapy occurred in the first 30 days, with comparable outcomes thereafter. Bleeding appeared to be lower at both 30 days and 12 months with monotherapy vs. DAPT.”
Extra info:
Patricia O. Guimarães et al, Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes, New England Journal of Drugs (2025). DOI: 10.1056/NEJMoa2507980
Supplied by
European Society of Cardiology
Quotation:
New trial proof on the usage of blood thinners after coronary stenting (2025, September 1)
retrieved 1 September 2025
from https://medicalxpress.com/information/2025-09-trial-evidence-blood-thinners-coronary.html
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