What is the clinical evidence from this study?

Study design: RCT. Population: ST elevation myocardial infarction (STEMI) undergoing primary PCI (n=60). Intervention: Cilostazol (added to aspirin and clopidogrel) vs. Standard dual regimen (aspirin and clopidogrel). Primary outcome: % inhibition of ADP-induced platelet aggregation (p=0.004).

January 1, 2007Circulation Journal50 citationsOpen Access

Cilostazol Could Ameliorate Platelet Responsiveness to Clopidogrel in Patients Undergoing Primary Percutaneous Coronary Intervention

JKJang‐Young Kim KLKyounghoon Lee MSMyungsang Shin

Key Result

Adding cilostazol to aspirin and clopidogrel significantly increased the inhibition of ADP-induced platelet aggregation (40.5% vs 23.8%, p=0.004) in patients undergoing primary percutaneous coronary intervention.

Study Design

Type

RCT (n=60)

Randomization

1:1

Multicenter

Structured PICO

Does the addition of cilostazol to aspirin and clopidogrel improve platelet responsiveness and reduce platelet activation in STEMI patients undergoing primary PCI?

Population

60 patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention within 12 hours of symptom onset were randomized to dual or triple antiplatelet therapy and followed for 1 month.

Intervention

Triple regimen: Aspirin (300 mg oral loading dose, then 100 mg daily) + Clopidogrel (600 mg loading dose, then 75 mg daily) + Cilostazol (400 mg loading dose, then 200 mg daily) for 1 month.

Comparator

Dual regimen: Aspirin (300 mg oral loading dose, then 100 mg daily) + Clopidogrel (600 mg loading dose, then 75 mg daily) for 1 month.

Outcome

Platelet aggregation measured by VerifyNow analyzer (P2Y12 reaction unit [PRU] and % inhibition of ADP-induced platelet aggregation) at 7 to 21 days, and plasma soluble CD40 ligand (sCD40L) levels at admission, 24 hours, and 21 days.surrogate

Adding cilostazol to standard dual antiplatelet therapy significantly increases the inhibition of ADP-induced platelet aggregation in STEMI patients undergoing primary PCI, potentially mitigating clopidogrel low-responsiveness.

Main Result

Absolute Event Rate: 40.5% vs 23.8%

p-value: p=0.004

Limitations

The sample size was relatively small.
Ex vivo platelet responsiveness was evaluated based on the VerifyNow P2Y12 test rather than the ideal method of light transmission aggregometry.
Small sample size
Ex vivo platelet responsiveness evaluated by VerifyNow instead of light transmission aggregometry

Abstract

BACKGROUND: Cilostazol increases the cyclic adenosine monophosphate levels in platelets and might ameliorate the antiplatelet activity of clopidogrel. This study investigated the additional effect of cilostazol on platelet aggregation measured by a VerifyNow analyzer and soluble CD40 ligand (sCD40L) as a marker of activated platelet in patients undergoing primary percutaneous coronary intervention (PCI). METHODS AND RESULTS: Sixty cases of primary PCI were randomly assigned to dual (aspirin and clopidogrel) or triple (dual plus cilostazol) therapy. The antiplatelet effects of aspirin and clopidogrel were evaluated by VerifyNow tests. The plasma sCD40L levels at admission, 24 h and 21 days were measured by the ELISA method. The arachidonic acid induced platelet aggregation was similar in both groups. However, the triple group had a significantly lower P2Y12 reaction unit (dual 208.8+/-69.0 vs triple 168.2+/-79.2, p=0.041) and higher % inhibition of adenosine diphosphate (ADP)-induced platelet aggregation (dual 23.8+/-21.4% vs triple 40.5+/-21.0%, p=0.004). In the multivariate analysis, cilostazol was a negative predictor for low responders to clopidogrel (95% confidence interval 0.067-0.711). The plasma sCD40L levels were not significantly different between the 2 groups at the same point of time. CONCLUSIONS: The addition of cilostazol to the combination of aspirin plus clopidogrel significantly increases the inhibition of ADP-induced platelet aggregation. However, there was no additive effect on aspirin-induced antiplatelet activity or lowering of sCD40L.

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