Key result
Additional administration of cilostazol for one month did not significantly decrease the 6-month MACE rate compared to dual antiplatelet therapy in patients with drug-eluting stents (2.65% vs 3.99%, p=0.864).
Why the study?
Does additional cilostazol administration reduce major adverse cardiac events in patients receiving dual antiplatelet therapy after drug-eluting stent insertion?
RCT (n=603)
Prospective randomized
No
Does additional cilostazol administration reduce major adverse cardiac events in patients receiving dual antiplatelet therapy after drug-eluting stent insertion?
Absolute Event Rate: 2.65% vs 3.99%
p-value: p=0.864
Additional administration of cilostazol for one month did not significantly decrease the 6-month MACE rate compared to standard dual antiplatelet therapy after DES insertion, despite showing some laboratory antiplatelet effects.
Cilostazol addition confers no MACE benefit after DES; reinforces standard DAPT without routine triple therapy.
Background and Objectives: Cilostazol, a selective inhibitor of phosphodiesterase III (PDE III), prevents inactivation of the intracellular second messenger cyclic adenosine monophosphate (cAMP) and irreversibly inhibits platelet aggregation and vasodilation. Hence, we performed this prospective randomized study to evaluate the clinical effects of additional cilostazol administration in patients receiving dual antiplatelet therapy after drugeluting stent (DES) insertion. Subjects and Methods: Between December 2003 and June 2006, we enrolled a total 603 consecutive patients who underwent successful percutaneous coronary intervention (PCI) with DES insertion at Dong-A University Hospital. Study patients received dual antiplatelet therapy (aspirin and clopidogrel, n=301) for at least six months or dual antiplatelet therapy (six months) combined with cilostazol medication for one month (triple therapy, n=302) after PCI. We investigated the incidence of major adverse cardiac events (MACE) at one month and six months after the initiation of medical therapy. MACE was defined as a composite of death, myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). Platelet function was evaluated in 66 patients (dual therapy group, n=40; triple therapy group, n=26) using a Chrono-Log platelet aggregometer and the VerifyNow P2Y12 assay system. Results: The MACE rate was 0.66% in the triple therapy group (death only, 0.67%) and 1.67% in the dual therapy group (death, 0.67%; MI, 0.67%; stent thrombosis, 0.99%; TLR, 0.99%) at one month after PCI (p=0.087). At six months, there were no differences in the MACE rate between the two groups (triple group vs. dual group=2.65% vs. 3.99%, p=0.864). In laboratory tests, platelet aggregation induced by agonists of ADP (27.92±13.04% vs. 40.9±15.78%, p=0.0008), collagen (13.73±6.95% vs. 27.43±14.87%, p=0.03), and epinephrine (10.38±7.82% vs. 15.5±10.45%, p=0.0000) were lower in the triple therapy group versus the dual therapy group. However, platelet aggregation induced by agonists of arachidonic acid (3.23±1.07% vs. 3.78±2.12%, p=0.23) and ristocetin (29.19±35.55% vs. 44.78±32.65%, p= 0.07) and aspirin reaction unit (412.96±96.25 vs. 427.93±76.24, p=0.48) measured by VerifyNow were not different in the triple group versus the dual group. Conclusion: Additional administration of cilostazol did not decrease the MACE rate when compared to dual therapy six months after PCI in patients with DES. (Korean Circ J 2009;39:21-25)
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Kum et al. (2009) conducted an RCT in Coronary artery disease requiring percutaneous coronary intervention with drug-eluting stent (n=603). Cilostazol (Triple antiplatelet therapy) vs. Dual antiplatelet therapy (aspirin and clopidogrel) was evaluated on Major adverse cardiac events (MACE) at 6 months (p=0.864). Additional administration of cilostazol for one month did not significantly decrease the 6-month MACE rate compared to dual antiplatelet therapy in patients with drug-eluting stents (2.65% vs 3.99%, p=0.864).
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