Madrid, Spain – 31 August 2025: There was no benefit to modulating the intensity of antiplatelet therapy compared with standard antiplatelet therapy in high-risk patients who had undergone complex stenting procedures, according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.1
Dual antiplatelet therapy (DAPT) consisting of aspirin plus a P2Y12 receptor inhibitor, such as clopidogrel, is generally given to patients after coronary stenting (percutaneous coronary intervention [PCI]) to prevent ischaemic events, such as heart attacks (myocardial infarction). Principal Investigator, Professor Duk-Woo Park from Asan Medical Center, Seoul, South Korea, explained why the TAILORED-CHIP trial was carried out: “The optimal antiplatelet therapy is not well established for patients who have undergone complex PCI procedures and are at high risk of ischaemic events. We hypothesised that modulating the intensity of antiplatelet therapy over time, i.e. stronger inhibition in the early phase to reduce ischaemic events and weaker inhibition in the later phase to mitigate bleeding, may be beneficial in this high-risk population. The TAILORED-CHIP trial was designed to study whether early escalation with low-dose ticagrelor plus aspirin and late de-escalation with clopidogrel alone would be better than standard clopidogrel plus aspirin.”
The open-label randomised TAILORED-CHIP trial was conducted at 24 sites in South Korea. Patients with high-risk anatomical or clinical characteristics undergoing complex PCI were enrolled and were randomised 1:1 to receive tailored antiplatelet strategy consisting of early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin for 6 months) then late de-escalation (clopidogrel monotherapy for 6 months) or standard DAPT (clopidogrel plus aspirin for 12 months).
The primary outcome was net adverse clinical events, defined as a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, unplanned urgent revascularisation and clinically relevant bleeding (BARC type 2, 3, or 5) at 12 months. Prespecified secondary outcomes included major ischaemic and clinically relevant bleeding events.
In total, 2,018 patients were enrolled. The mean age was 64.0 years and 17.1% were women. Most patients (93.7%) had PCI conducted in at least two major heart vessels during the same procedure.
At 12 months, the primary of outcome of net adverse clinical events was not significantly different between the groups, occurring in 10.5% of patients assigned to tailored antiplatelet therapy and in 8.8% of patients assigned to standard DAPT (hazard ratio [HR] 1.19; 95% confidence interval [CI] 0.90 to 1.58; p=0.21).
There was no significant difference in the incidence of major ischaemic events at 12 months between the tailored-therapy and DAPT groups (3.9% vs. 5.0%, respectively; HR 0.78; 95% CI 0.52 to 1.19; p=0.25). However, the incidence of clinically relevant bleeding at 12 months was significantly higher in the tailored-therapy group (7.2%) compared with the DAPT group (4.8%; absolute difference 2.45%; 95% CI 0.37% to 4.53%; p=0.002). The incidence of major bleeding was similar in the tailored-therapy group (1.7%) and the DAPT group (1.5%; absolute difference 0.21%; 95% CI −0.89% to 1.31%; p=0.70).
Summarising the findings, Professor Park said: “Our results suggest that a tailored strategy in patients undergoing complex high-risk PCI does not provide a net clinical benefit. We observed an increase in bleeding complications without a significant reduction in ischaemic events. This challenges the notion that ‘more is better’ even in carefully selected patients at high ischaemic risk undergoing complex PCI procedures. Standard 12-month DAPT remains appropriate.”
Notes to editor
This press release accompanies both a presentation and an ESC press conference at ESC Congress 2025.
It does not necessarily reflect the opinion of the European Society of Cardiology.
Funding: This study was funded by the CardioVascular Research Foundation and ChongKunDang Pharmaceutical Corp.
Disclosures: Professor Park reports research grants for this trial from the CardioVascular Research Foundation and ChongKunDang Pharmaceutical Corp. and reports research grants for other research projects and speaker fees from Abbott Vascular, Medtronic, Boston Scientific, Daiichi-Sankyo, Edwards Lifesciences, ChongKunDang Pharm, Daewoong Pharm and HK inno.N Co., Ltd.
References and notes:
1‘TAILORED-CHIP: Tailored antiplatelet therapy for complex high-Risk PCI’ presented during HOT LINE 7 on 31 August 2025 at 16:30 to 16:40 in Madrid (Main Auditorium).
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