Tailored Antiplatelet Therapy in High-Risk Diabetic Patients Undergoing Complex Percutaneous Coronary Intervention: The Prespecified Analysis of TAILORED-CHIP Trial

초록

BACKGROUND Patients with diabetes mellitus (DM) undergoing complex percutaneous coronary intervention (PCI) face enhanced ischemic risk owing to altered platelet function and cardiovascular comorbidities. The optimal antiplatelet regimen for this high-risk population following complex PCI remains uncertain. METHODS The TAILORED-CHIP (Tailored versus Conventional Antithrombotic Strategy Intended for Complex High-Risk PCI) trial was a randomized controlled trial comparing a tailored antiplatelet strategy with early escalation (low-dose ticagrelor 60 mg twice daily plus aspirin for <6 months) followed by late de-escalation (clopidogrel monotherapy for 6 months) versus conventional dual antiplatelet therapy (DAPT) (clopidogrel plus aspirin for 12 months) in high-risk patients undergoing complex PCI. Randomization was stratified by the status of DM. 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 Among 2,018 randomized patients, diabetic patients (n=794, 39.3%) had a higher risk of clinical and anatomical profiles than non-diabetic patients (n=1,224, 60.7%). At 12 months, patients with DM showed a similar rate of primary composite events compared to those without DM (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.73–1.30; P=0.88). The 12-month incidence of the primary composite outcome was similar between tailored and conventional antiplatelet strategies in patients with DM (10.1% vs. 9.5%; HR, 1.07; 95% CI, 0.69–1.68; P=0.76) and in those without DM (10.8% vs. 8.4%; HR, 1.28; 95% CI, 0.89–1.84; P=0.18), with no significant interaction (P=0.55). Major ischemic events occurred at similar rates between the two antiplatelet strategies regardless of diabetes status. The 12-month incidence of clinically relevant bleeding was significantly higher with tailored therapy than with standard DAPT in non-diabetic patients (7.4% vs. 4.0%; difference, 3.40 percentage points; 95% CI, 0.81–5.99), while bleeding rates were comparable between the two antiplatelet strategies in diabetic patients (7.0% vs. 6.0%; difference, 1.00 percentage points; 95% CI, −2.44–4.44). CONCLUSIONS Irrespective of diabetes status, the tailored antiplatelet strategy involving early escalation followed by late de-escalation showed similar net clinical outcomes compared to conventional DAPT in high-risk patients undergoing complex PCI. The presence of diabetes did not modify the treatment effect of the tailored antiplatelet strategy.