Key result
Cilostazol had a borderline effect on reducing MACE (HR 0.67; 95% CI 0.34-1.33) compared to placebo, but significantly reduced the risk of major coronary events (HR 0.38; 95% CI 0.17-0.86).
Why the study?
Cilostazol favorably affects glucose and lipid homeostasis, endothelial function, atherosclerosis, and vasculo-angiogenesis, but whether these effects translate into better clinical outcomes was poorly understood.
Does cilostazol reduce major adverse cardiovascular events in patients with coronary artery disease or at high risk of cardiovascular disease?
RCT (n=266)
Double-blind
randomized
Does cilostazol reduce major adverse cardiovascular events in patients with coronary artery disease or at high risk of cardiovascular disease?
Hazard Ratio: 0.67 (95% CI 0.34–1.33)
Cilostazol significantly reduced the risk of major coronary and cerebrovascular events in patients with CAD or high cardiovascular risk, although the reduction in the primary MACE endpoint was not statistically significant.
Leaves open whether cilostazol improves hard clinical outcomes in coronary artery disease; larger trials are needed.
Previous studies found that cilostazol has a favorable effect on glucose and lipid homeostasis, endothelial function, atherosclerosis, and vasculo-angiogenesis. However, it is poorly understood whether these effects can translate into better clinical outcomes. This study investigated the outcome effect of cilostazol in patients with coronary artery disease (CAD) or at a high risk of cardiovascular (CV) disease. We conducted a randomized, double-blind, placebo-controlled trial involving 266 patients who received cilostazol, 200 mg/day (n = 134) or placebo (n = 132). Pre-specified clinical endpoints including composite major adverse cardiovascular events (MACE) (CV death, non-fatal myocardial infarct, non-fatal stroke, hospitalization for heart failure, or unplanned coronary revascularization), the composite major coronary event (MCE) and major adverse CV and cerebrovascular event (MACCE), were prospectively assessed. The mean duration of follow-up was 2.9 years. Relative to placebo, cilostazol treatment had a borderline effect on risk reduction of MACE (hazard ratio [HR], 0.67; 95% confidence interval (CI), 0.34–1.33), whereas the beneficial effect in favor of cilostazol was significant in patients with diabetes mellitus or a history of percutaneous coronary intervention (p for interaction, 0.02 and 0.06, respectively). Use of cilostazol, significantly reduced the risk of MCE (HR, 0.38; 95% CI, 0.17–0.86) and MACCE (HR, 0.47; 95% CI, 0.23–0.96). A significantly lower risk of angina pectoris (HR, 0.38; 95% CI, 0.17–0.86) was also observed in the cilostazol group. After multi-variable adjustment, cilostazol treatment independently predicted a lower risk of MCE. In conclusion, these results suggest cilostazol may have beneficial effects in patients with CAD or at a high risk of CV disease.
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Lin et al. (2022) conducted an RCT in Coronary artery disease or high risk of cardiovascular disease (n=266). Cilostazol vs. Placebo was evaluated on Composite major adverse cardiovascular events (MACE) (CV death, non-fatal myocardial infarct, non-fatal stroke, hospitalization for heart failure, or unplanned coronary revascularization) (HR 0.67, 95% CI 0.34-1.33). Cilostazol had a borderline effect on reducing MACE (HR 0.67; 95% CI 0.34-1.33) compared to placebo, but significantly reduced the risk of major coronary events (HR 0.38; 95% CI 0.17-0.86).
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