Sep 3 2025
Noninferiority was not demonstrated for decease and ischemic events betwixt P2Y12 inhibitor monotherapy and dual antiplatelet therapy (DAPT) fixed for 12 months aft stenting successful patients pinch acute coronary syndromes (ACS), according to late-breaking investigation presented successful a Hot Line convention coming astatine ESC Congress 2025 and simultaneously published successful New England Journal of Medicine.
DAPT consisting of aspirin positive a potent P2Y12 inhibitor for 12 months is recommended for patients pinch ACS (myocardial infarction [MI] and unstable angina) aft percutaneous coronary involution (PCI) pinch stent implantation.
Recent grounds suggests that withdrawal of aspirin aft 1 to 3 months of DAPT, followed by P2Y12 inhibitor monotherapy whitethorn trim bleeding while preventing recurrent ischemic events compared pinch 12 months of DAPT. We conducted nan NEO-MINDSET proceedings to specifically analyse if P2Y12 inhibitor monotherapy could beryllium utilized successful nan early phase, instantly aft PCI and for nan full 12 months compared pinch DAPT for 12 months."
Pedro Lemos, Principal Investigator, Professor from nan Hospital Israelita Albert Einstein, Sao Paulo, Brazil
The open-label randomized controlled NEO-MINDSET proceedings was conducted crossed 50 sites successful Brazil. Patients pinch ACS undergoing successful PCI pinch drug-eluting stents were randomized 1:1 wrong nan first 4 days of hospitalisation to extremity aspirin and person potent P2Y12 inhibitor monotherapy (ticagrelor aliases prasugrel) aliases to DAPT (aspirin positive a potent P2Y12 inhibitor) for 12 months.
The first superior result was a composite of death, MI, changeable aliases urgent target-vessel coronary revascularisation, pinch an absolute consequence quality of 2.5 percent points group arsenic nan prespecified noninferiority margin. The 2nd superior result was awesome aliases clinically applicable nonmajor bleeding, pinch superiority testing if nan first superior result was noninferior.
The study organization included 3,410 randomized patients who had a mean property of 59.6 years, pinch 29.3% being women.
The ischemic superior endpoint occurred successful 7.0% of patients successful nan monotherapy group and 5.5% successful nan DAPT group (hazard ratio [HR] 1.28; 95% assurance interval [CI] 0.98 to 1.68), resulting successful an absolute consequence quality of +1.47 percent points (95% CI −0.16 to 3.10), which did not meet nan prespecified criteria for noninferiority (p=0.11).
Major aliases clinically applicable nonmajor bleeding occurred successful 2.0% of patients successful nan monotherapy group and 4.9% successful nan DAPT group (risk quality −2.97 percent points; 95% CI −4.20 to −1.73).
The incidence of all-cause decease was 3.6% successful nan monotherapy group and 3.0% successful nan DAPT group (HR 1.24; 95% CI 0.85 to 1.79). Any bleeding occurred successful 4.5% of patients successful nan monotherapy group and 9.0% successful nan DAPT group.
A landmark study connected nan ischemic superior endpoint revealed a consequence quality of +1.5 percent points during nan first 30 days and 0.0 percent points from 30 days to 12 months for P2Y12 inhibitor monotherapy vs. DAPT. For nan bleeding superior endpoint, nan consequence quality was −0.8 percent points during nan first 30 days and −2.2 percent points from 30 days to 12 months for monotherapy vs. DAPT.
Summarizing nan findings, Professor Lemos concluded: "We grounded to show nan noninferiority of aspirin-free monotherapy initiated instantly aft PCI pinch respect to nan ischemic superior endpoint complete 12 months. Results from nan landmark study propose that nan excess ischemic consequence pinch monotherapy occurred successful nan first 30 days, pinch comparable outcomes thereafter. Bleeding appeared to beryllium little astatine some 30 days and 12 months pinch monotherapy vs. DAPT."
Source:
European Society of Cardiology (ESC)
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