Noninferiority was not demonstrated for loss of life and ischemic occasions between P2Y12 inhibitor monotherapy and twin antiplatelet remedy (DAPT) given for 12 months after stenting in patients with acute coronary syndromes (ACS), in keeping with late-breaking analysis offered in a Hot Line session right now at ESC Congress 2025 and concurrently revealed in New England Journal of Medicine.
DAPT consisting of aspirin plus a potent P2Y12 inhibitor for 12 months is beneficial for patients with ACS (myocardial infarction [MI] and unstable angina) after percutaneous coronary intervention (PCI) with stent implantation.
Recent proof means that withdrawal of aspirin after 1 to three months of DAPT, adopted by P2Y12 inhibitor monotherapy could cut back bleeding whereas stopping recurrent ischemic occasions in contrast with 12 months of DAPT. We performed the NEO-MINDSET trial to particularly examine if P2Y12 inhibitor monotherapy might be used in the early section, instantly after PCI and for the total 12 months in contrast with DAPT for 12 months.”
Pedro Lemos, Principal Investigator, Professor from the Hospital Israelita Albert Einstein, Sao Paulo, Brazil
The open-label randomized managed NEO-MINDSET trial was performed throughout 50 websites in Brazil. Patients with ACS present process profitable PCI with drug-eluting stents have been randomized 1:1 inside the first 4 days of hospitalisation 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 first main consequence was a composite of loss of life, MI, stroke or pressing target-vessel coronary revascularisation, with an absolute danger distinction of 2.5 proportion factors set as the prespecified noninferiority margin. The second main consequence was main or clinically related nonmajor bleeding, with superiority testing if the first main consequence was noninferior.
The evaluation inhabitants included 3,410 randomized patients who had a imply age of 59.6 years, with 29.3% being girls.
The ischemic main endpoint occurred in 7.0% of patients in the monotherapy group and 5.5% in the DAPT group (hazard ratio [HR] 1.28; 95% confidence interval [CI] 0.98 to 1.68), ensuing in an absolute danger distinction of +1.47 proportion factors (95% CI −0.16 to three.10), which didn’t meet the prespecified standards for noninferiority (p=0.11).
Major or clinically related nonmajor bleeding occurred in 2.0% of patients in the monotherapy group and 4.9% in the DAPT group (danger distinction −2.97 proportion factors; 95% CI −4.20 to −1.73).
The incidence of all-cause loss of life was 3.6% in the monotherapy group and three.0% in the DAPT group (HR 1.24; 95% CI 0.85 to 1.79). Any bleeding occurred in 4.5% of patients in the monotherapy group and 9.0% in the DAPT group.
A landmark evaluation on the ischemic main endpoint revealed a danger distinction of +1.5 proportion factors throughout the first 30 days and 0.0 proportion factors from 30 days to 12 months for P2Y12 inhibitor monotherapy vs. DAPT. For the bleeding main endpoint, the danger distinction was −0.8 proportion factors throughout the first 30 days and −2.2 proportion factors from 30 days to 12 months for monotherapy vs. DAPT.
Summarizing the findings, Professor Lemos concluded: “We didn’t display the noninferiority of aspirin-free monotherapy initiated instantly after PCI with regard to the ischemic main endpoint over 12 months. Results from the landmark evaluation counsel that the extra ischemic danger with monotherapy occurred in the first 30 days, with comparable outcomes thereafter. Bleeding gave the impression to be decrease at each 30 days and 12 months with monotherapy vs. DAPT.”