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Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial

OBJECTIVES: We aimed to test whether cilostazol has beneficial effects in the real-world patients treated with intracoronary drug-eluting stents (DES). BACKGROUND: The addition of cilostazol on the conventional dual antiplatelet therapy has been reported to reduce platelet reactivity and to improve clinical outcomes after percutaneous coronary intervention in previous studies. METHODS: In a randomized multicenter trial, we enrolled 960 patients who received DES. They were randomized to receive either dual antiplatelet therapy (DAT) (aspirin and clopidogrel) or triple antiplatelet therapy (TAT) (aspirin, clopidogrel, and cilostazol) for 6 months. Primary end point was the composite of cardiac death, nonfatal myocardial infarction, ischemic stroke, or target lesion revascularization (TLR). Secondary end points were P2Y12 reaction unit (PRU) measured with the VerifyNow P2Y12 assay (Accumetrics, San Diego, California) at discharge and at 6 months after the index procedure. All-cause death, stent thrombosis, and each component of the primary end point at 6 months were other secondary end points. Analysis was done on an intention-to-treat basis. RESULTS: At 6 months' follow-up, there was no difference in the primary end point between the 2 groups (8.5% in TAT vs. 9.2% in DAT, p = 0.74). In secondary end point analysis, the TAT group achieved lower PRU levels than the DAT group both at discharge (206.6 +/- 90.3 PRU vs. 232.2 +/- 80.3 PRU, p < 0.001) and at 6 months (210.7 +/- 87.9 PRU vs. 255.7 +/- 73.7 PRU, p < 0.001). In the Cox proportional hazards analysis, lesion length (>=28 mm, hazard ratio [HR]: 2.10, 95% confidence interval [CI]: 1.25 to 3.52), and PRU level at discharge (every increase in tertile, HR: 1.61, 95% CI: 1.16 to 2.25) were predictors of the primary end point, but not the use of cilostazol (HR: 0.90, 95% CI: 0.54 to 1.52). CONCLUSIONS: Despite the greater reduction of platelet reactivity by addition of cilostazol to conventional DAT, TAT did not show superiority in reducing the composite of adverse cardiovascular outcomes after DES implantation. (The Efficacy of CILostazol ON Ischemic Complications After DES Implantation [CILON-T]; NCT00776828).

Trial
Journal Ref. Suh J-W, Lee S-P, Park K-W, Lee H-Y, Kang H-J, Koo B-K, Cho Y-S, Youn T-J, Chae I-H, Choi D-J, et al: Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. Journal of the American College of Cardiology 2011, 57:280-289.
Intervention Drug - Cilostazol (loading dose 200mg, then 100mg BD for 6 months)
Number of sites 5
Countries involved South Korea
Sample size 960
Type of statistical analyses Intention-to-treat
Risk of bias Overall: Unclear details
Participant characteristics Age: 64
Condition: Coronary artery disease
Baseline severity: Intracoronary drug-eluting stents (DES)
Duration of trial 30 months: September 2006 to June 2009
Primary outcome Composite of major adverse cardiovascular events, cardiac death, non-fatal MI, clinically driven target lesion revascularization (TLR) and ischemic stroke at 6 months
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
39 457 42 458 -0.64 %
p value 0.73 (95% CI 0.59-1.46)
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
3 3 2 5 5 3 2 2 1