Early escalation, late de-escalation of antiplatelet therapy is not beneficial in patients after complex stenting: Trial

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 at the ESC Congress 2025.

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 ischemic 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 ischemic events.

“We hypothesized that modulating the intensity of antiplatelet therapy over time, i.e. stronger inhibition in the early phase to reduce ischemic 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 randomized 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 randomized 1:1 to receive tailored antiplatelet strategy consisting of early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin for six months), then late de-escalation (clopidogrel monotherapy for six 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 revascularization and clinically relevant bleeding (BARC type 2, 3, or 5) at 12 months. Prespecified secondary outcomes included major ischemic 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 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 ischemic 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).

Summarizing 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 ischemic events.

“This challenges the notion that ‘more is better’ even in carefully selected patients at high ischemic risk undergoing complex PCI procedures. Standard 12-month DAPT remains appropriate.”

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 at the ESC Congress 2025.

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 ischemic 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 ischemic events.

“We hypothesized that modulating the intensity of antiplatelet therapy over time, i.e. stronger inhibition in the early phase to reduce ischemic 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 randomized 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 randomized 1:1 to receive tailored antiplatelet strategy consisting of early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin for six months), then late de-escalation (clopidogrel monotherapy for six 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 revascularization and clinically relevant bleeding (BARC type 2, 3, or 5) at 12 months. Prespecified secondary outcomes included major ischemic 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 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 ischemic 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).

Summarizing 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 ischemic events.

“This challenges the notion that ‘more is better’ even in carefully selected patients at high ischemic risk undergoing complex PCI procedures. Standard 12-month DAPT remains appropriate.”