Abstract
Background: Endothelial progenitor cells (EPCs) have the potential to protect against atherothrombotic event occurrences. There are no data to evaluate the impact of cilostazol on EPC levels in high-risk patients. Methods: We conducted a randomized, double-blind, placebo-controlled trial to assess the effect of adjunctive cilostazol on EPC mobilization and platelet reactivity in patients with acute myocardial infarction (AMI). Before discharge, patients undergoing percutaneous coronary intervention (PCI) were randomly assigned to receive cilostazol SR capsule (200-mg) a day (n = 30) or placebo (n = 30) on top of dual antiplatelet therapy (DAPT) with clopidogrel and aspirin. Before randomization (baseline) and at 30-day follow-up, circulating EPC levels were analyzed using flow cytometry and hemostatic measurements were evaluated by VerifyNow and thromboelastography assays. The primary endpoint was the relative change in EPC levels between baseline and 30-day. Results: At baseline, there were similar levels of EPC counts between treatments, whereas patients with cilostazol showed higher levels of EPC counts compared with placebo after 30 days. Cilostazol versus placebo treatment displayed significantly higher changes in EPC levels between baseline and follow-up (ΔCD133+/KDR+: difference 216%, 95% confidence interval (CI) 44~388%, p = 0.015; ΔCD34+/KDR+: difference 183%, 95% CI 25~342%, p = 0.024). At 30-day follow-up, platelet reactivity was lower in the cilostazol group compared with the placebo group (130 ± 45 versus 169 ± 62 P2Y12 Reaction Unit, p = 0.009). However, there were no significant correlations between the changes of EPC levels and platelet reactivity. Conclusion: Adjunctive cilostazol on top of clopidogrel and aspirin versus DAPT alone is associated with increased EPC mobilization and decreased platelet reactivity in AMI patients, suggesting its pleiotropic effects against atherothrombotic events (NCT04407312).
Highlights
Reperfusion with percutaneous coronary intervention (PCI) significantly reduced mortality after acute myocardial infarction (AMI) [1]
The EPISODE study first demonstrated the influence of cilostazol on Endothelial progenitor cells (EPCs) mobilization in AMI patients
The key findings of the study are as below; (1) adjunctive cilostazol therapy in addition to dual antiplatelet therapy (DAPT) significantly increased EPC levels compared with DAPT alone; (2) triple antiplatelet therapy with cilostazol versus DAPT was associated with the reduction of P2Y12 Reaction Units (PRU); and (3) EPC mobilization by cilostazol may not be related with its effect of platelet inhibition
Summary
Reperfusion with percutaneous coronary intervention (PCI) significantly reduced mortality after acute myocardial infarction (AMI) [1]. Delayed or impaired arterial healing is associated with increased risk of stent-related adverse events [6] This prompts additional treatment options to promote a vascular healing process. Patients undergoing percutaneous coronary intervention (PCI) were randomly assigned to receive cilostazol SR capsule (200-mg) a day (n = 30) or placebo (n = 30) on top of dual antiplatelet therapy (DAPT) with clopidogrel and aspirin. Cilostazol versus placebo treatment displayed significantly higher changes in EPC levels between baseline and follow-up (∆CD133+/KDR+: difference 216%, 95% confidence interval (CI) 44~388%, p = 0.015; ∆CD34+/KDR+: difference 183%, 95% CI 25~342%, p = 0.024). Conclusion: Adjunctive cilostazol on top of clopidogrel and aspirin versus DAPT alone is associated with increased EPC mobilization and decreased platelet reactivity in AMI patients, suggesting its pleiotropic effects against atherothrombotic events (NCT04407312)
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