Key result
Tailored antiplatelet strategy fails to reduce 12-month net adverse events compared with standard DAPT.
Why the study?
Does a tailored antiplatelet strategy with early escalation and late de-escalation reduce net adverse clinical events compared to standard 12-month dual antiplatelet therapy in high-risk patients undergoing complex PCI?
RCT (n=2,018)
randomized
Does a tailored antiplatelet strategy with early escalation and late de-escalation reduce net adverse clinical events compared to standard 12-month dual antiplatelet therapy in high-risk patients undergoing complex PCI?
Hazard Ratio: 1.19 (95% CI 0.9–1.58)
Absolute Event Rate: 10.5% vs 8.8%
p-value: p=0.21
In high-risk patients undergoing complex PCI, a tailored antiplatelet strategy with early escalation and late de-escalation did not improve net clinical outcomes and increased bleeding compared to standard 12-month dual antiplatelet therapy.
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. 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. 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). 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. ClinicalTrials.gov number, NCT03465644.
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Kang et al. (2025) conducted an RCT in High-risk patients undergoing complex percutaneous coronary intervention (PCI) (n=2,018). Tailored antiplatelet strategy vs. Dual antiplatelet therapy (clopidogrel plus aspirin for 12 months) was evaluated on 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 (HR 1.19, 95% CI 0.90-1.58, p=0.21). A tailored antiplatelet strategy did not decrease primary net adverse events at 12 months compared with dual antiplatelet therapy (HR 1.19; 95% CI 0.90-1.58; P=0.21).
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