The optimal duration of DAPT after coronary stenting remains a debated topic in interventional cardiology (1-3). Several trials, such as TICO, T-PASS, and ULTIMATE-DAPT, have shown reduced bleeding risk without an increase in ischaemic events when aspirin is discontinued after 1–3 months of DAPT and patients continue potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) (4–5). NEO-MINDSET took this a step further by exploring whether aspirin could be stopped safely immediately after successful PCI, within the first four days of hospitalisation (1).
Why is this important?
The peri-procedural and early post-PCI period carries a high risk of both thrombosis and bleeding. If monotherapy were effective in this window, it could spare patients significant bleeding complications while simplifying treatment.
Methods
NEO-MINDSET was an investigator-driven, open-label, multicentre randomised trial that enrolled 3,410 patients across 50 sites in Brazil. It included patients with acute coronary syndromes (STEMI, NSTEMI, or unstable angina) who had undergone successful PCI with contemporary drug-eluting stents (1).
Participants were randomised 1:1 to either:
- Immediate aspirin discontinuation with potent P2Y12 inhibitor monotherapy (prasugrel ~70%, ticagrelor ~28%), or
- DAPT with aspirin plus a potent P2Y12 inhibitor,
continued for 12 months (1).
Two ranked primary outcomes were analysed:
- Non-inferiority for a composite of death from any cause, myocardial infarction, stroke, or urgent target-vessel revascularization.
- If non-inferiority was met, superiority for major or clinically relevant nonmajor bleeding (BARC type 2, 3, or 5).
The results
In the monotherapy arm, the first primary outcome (death, MI, stroke, or urgent target-vessel revascularization) occurred in 7% of patients compared with 5% in the DAPT group (absolute risk difference +1.47 percentage points; 95% CI, −0.16 to 3.10; p = 0.11 for non-inferiority). Monotherapy was not non-inferior to DAPT for preventing death, MI, stroke, or urgent target-vessel revascularization.
The second primary outcome (major or clinically relevant non-major bleeding; BARC 2/3/5) occurred in 2% of the monotherapy group compared with 4.9% of the DAPT group (HR 0.40; 95% CI, 0.26 to 0.59). Stent thrombosis occurred in 12 patients in the monotherapy arm versus 4 patients in the DAPT arm.
Why this matters?
NEO-MINDSET suggests that the timing of aspirin de-escalation matters. Prior trials that stopped aspirin after 1-3 months, while continuing potent P2Y12 inhibitor monotherapy, generally showed no excess ischemic risk and reduced bleeding (4–5,13). In contrast, STOPDAPT-3 and NEO-MINDSET indicate that the very early post-PCI period is particularly vulnerable, and dual-pathway platelet inhibition still appears important during this phase (6-9). In the first week after an acute coronary syndrome, the prothrombotic milieu is high, and enhanced platelet inhibition with both aspirin and a P2Y12 inhibitor may be required.
Importance for healthcare professionals
Current ESC and NICE guidance recommend 12 months of DAPT after PCI for ACS, while advising that duration should be tailored to individual bleeding and thrombotic risk profiles (10–12).
NEO-MINDSET reinforces this approach:
- Avoid stopping aspirin immediately after PCI.
- A reasonable de-escalation timeframe appears to be after 1–3 months, as supported by trials such as TICO, ULTIMATE-DAPT, and other ticagrelor monotherapy studies (4–5,9,13).
- Use a patient-tailored approach, individualising de-escalation based on both bleeding and ischaemic risk.
References
- 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.
- ESC Congress 2025 coverage of the NEO-MINDSET study (conference materials / online summaries).
- Valgimigli M, et al. Dual antiplatelet therapy duration following percutaneous coronary intervention in acute coronary syndromes: contemporary review.
- Kim BK, et al. Ticagrelor with or without aspirin in acute coronary syndrome (TICO trial).
- ULTIMATE-DAPT Investigators. One-month ticagrelor monotherapy after PCI in acute coronary syndromes (ULTIMATE-DAPT).
- STOPDAPT-3 and related early aspirin-withdrawal studies in ACS-PCI populations.
- ESC press communication on NEO-MINDSET and TARGET-FIRST: early aspirin discontinuation and outcomes after PCI.
- ACC summary: new studies exploring early aspirin withdrawal and tailored antiplatelet therapy at ESC 2025.
- ESC Congress news: TARGET-FIRST – early aspirin discontinuation in low-risk MI with complete revascularisation.
- NICE guideline NG185: Acute coronary syndromes – antiplatelet therapy recommendations after PCI.
- AHA/ACC 2025 Guideline for the management of patients with acute coronary syndromes – antiplatelet therapy section.
- Angiolillo DJ, et al. De-escalation or abbreviation of dual antiplatelet therapy in ACS and PCI: international expert consensus.
- Contemporary ticagrelor monotherapy trials after short DAPT in ACS and PCI (e.g. T-PASS, GLOBAL LEADERS sub-analyses).