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Temporal modulation of antiplatelet therapy in high-risk patients undergoing complex percutaneous coronary
Do-Yoon Kang1, Seong-Bong Wee1, Jung-Min Ahn1
1Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.
Insights
A tailored antiplatelet strategy did not reduce adverse events in high-risk patients undergoing complex percutaneous coronary intervention (PCI). The study found similar ischemic event rates but increased bleeding with tailored therapy compared to standard dual antiplatelet therapy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Optimal antiplatelet strategies for high-risk patients undergoing complex percutaneous coronary intervention (PCI) remain unclear.
- This study addresses the need for evidence on tailored antiplatelet regimens in this population.
Purpose of the Study:
- To investigate the efficacy and safety of a tailored antiplatelet strategy involving temporal modulation of platelet inhibition intensity.
- To compare this tailored approach with standard dual antiplatelet therapy in patients undergoing complex PCI.
Main Methods:
- A randomized trial involving 2018 high-risk patients undergoing complex PCI.
- Patients were assigned to either a tailored strategy (early escalation with ticagrelor/aspirin, late de-escalation to clopidogrel) or standard dual antiplatelet therapy (clopidogrel/aspirin for 12 months).
- The primary outcome was a composite of major adverse events (death, MI, stroke, stent thrombosis, urgent revascularization) and clinically relevant bleeding at 12 months.
Main Results:
- The primary composite outcome occurred in 10.5% of the tailored therapy group versus 8.8% in the dual therapy group (HR, 1.19; 95% CI, 0.90-1.58; P = .21).
- Major ischemic events were similar between the groups.
- Clinically relevant bleeding was higher in the tailored therapy group (7.2%) compared to the dual therapy group (4.8%).
Conclusions:
- A tailored antiplatelet strategy with early escalation and late de-escalation did not reduce the incidence of net adverse events at 12 months in high-risk patients undergoing complex PCI.
- The tailored approach was associated with a numerically higher rate of primary events and significantly more bleeding events compared to standard dual antiplatelet therapy.
Background And Aims:
Limited data exist on optimal antiplatelet strategies for high-risk patients undergoing complex percutaneous coronary intervention (PCI). This study aimed to investigate the efficacy and safety of tailored antiplatelet treatment with temporal modulation of the intensity of platelet inhibition in patients undergoing complex high-risk PCI.
Methods:
We randomly assigned 2018 patients with high-risk anatomical or clinical characteristics undergoing complex PCI to a tailored antiplatelet strategy with early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin <6 months) and late de-escalation (clopidogrel monotherapy >6 months) or dual antiplatelet therapy (clopidogrel plus aspirin for 12 months). The primary outcome was a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, unplanned urgent revascularization, and clinically relevant bleeding (Bleeding Academic Research Consortium Type 2, 3, or 5) at 12 months.
Results:
The mean age was 64.0 years, 22.6% had left main PCI, 19.5% had complex bifurcation PCI, 84.1% had diffuse long lesions, 93.7% had multivessel PCI, and 36.7% had medically treated diabetes. At 12 months, a primary outcome event occurred in 105 patients (10.5%) assigned to tailored antiplatelet therapy and in 89 patients (8.8%) assigned to dual antiplatelet therapy [hazard ratio, 1.19; 95% confidence interval (CI), 0.90-1.58; P = .21]. The incidence of major ischaemic events appeared to be similar in both groups. The incidence of clinically relevant bleeding at 12 months was 7.2% in the tailored-therapy group and 4.8% in the dual-therapy group (difference, 2.45% points; 95% CI, 0.37-4.53).
Conclusions:
Among high-risk patients undergoing complex PCI, tailored antiplatelet strategy with early escalation and late de-escalation, as compared with dual antiplatelet therapy, did not decrease the incidence of primary net adverse events at 12 months.
Clinical Trial Registration:
ClinicalTrials.gov number, NCT03465644.
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