Madrid, Spain – 31 August 2025: Among low-risk patients with acute MI who underwent early complete revascularisation and received one month of dual antiplatelet therapy (DAPT), P2Y12 inhibitor monotherapy was noninferior to continued DAPT for adverse cardiovascular and cerebrovascular events, while reducing bleeding risk. These late-breaking findings were presented in a Hot Line session today at ESC Congress 2025 and simultaneously published in New England Journal of Medicine.1
Current ESC Guidelines recommend 12 months of DAPT − aspirin plus a potent P2Y12 inhibitor − after percutaneous coronary intervention (PCI) for MI.2 Principal Investigator of the TARGET-FIRST trial, Professor Giuseppe Tarantini from the University of Padua, Italy, explained: “No randomised trials have previously assessed early aspirin discontinuation in acute MI patients who achieve early, complete revascularisation with modern stents. In such cases, bleeding risk may outweigh residual ischaemic risk, making antiplatelet therapy de-escalation attractive.”
In this open-label randomised controlled trial conducted at 40 European centres, eligible adults with an ST-segment elevation MI (STEMI) or non-STEMI underwent complete revascularisation within seven days using a contemporary drug-eluting stent and completed one month of DAPT without adverse events. They were randomised 1:1 to continue DAPT or switch to P2Y12 inhibitor monotherapy for 11 months. The primary endpoint was a composite of all-cause death, MI, stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) type 3/5 bleeding at 11 months. Noninferiority was defined as an absolute difference ≤1.25 percentage points in the upper bound of the two-sided 95% CI.
The mean age of the 1,942 randomised patients was 61 years and 21.6% were women.
The primary endpoint occurred in 2.10% of the P2Y12 inhibitor monotherapy group and 2.18% of the continued DAPT group (difference –0.09 percentage points; 95% CI –1.39 to 1.20; p=0.021 for noninferiority). MI occurred in 0.7% vs. 1.1%, definite/probable stent thrombosis in 0.1% vs. 0.0% and ischaemic stroke in 0.3% vs. 0.2%, respectively. BARC type 3/5 bleeding occurred in 0.7% in each group.
The main secondary endpoint (BARC type 2/3/5 bleeding) was significantly lower with P2Y12 inhibitor monotherapy (2.65% vs. 5.57%; hazard ratio [HR] 0.46; 95% CI 0.29 to 0.75; p=0.002). The patient-oriented composite outcome (all-cause death, MI, stent thrombosis, stroke, repeat ischaemia-driven revascularisation or BARC type 2/3/5 bleeding) occurred in 4.5% in the monotherapy group and 7.2% in the DAPT group (HR 0.61; 95% CI 0.42 to 0.89). Therapy adherence at 11 months was high in both groups (86.9% with monotherapy and 88.6% with DAPT).
Professor Tarantini concluded: “In low-risk acute MI patients with early complete revascularisation and no complications after one month of DAPT, switching to P2Y12 inhibitor monotherapy-maintained protection from ischaemic events and reduced bleeding. These results reflect the benefits of modern stents, high procedural success and optimal medical therapy, making early aspirin discontinuation feasible in this selected population.”
Notes to editor
This press release accompanies a presentation at ESC Congress 2025.
It does not necessarily reflect the opinion of the European Society of Cardiology.
Funding: This study was funded by MicroPort CRM.
Disclosures: Professor Tarantini reports receiving lecture fees from MicroPort CRM.
References and notes:
1‘TARGET-FIRST: Early aspirin discontinuation after PCI in acute MI patients’ presented during HOT LINE 7 on 31 August 2025 at 16:45 to 16:55 in Madrid (Main Auditorium) and simultaneously published in New England Journal of Medicine.
2Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023;44:3720−3826.
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