Key result
Cilostazol-based triple antiplatelet therapy did not significantly increase the risk of major bleeding compared to dual antiplatelet therapy (RR 1.23) in patients with coronary artery disease undergoing percutaneous coronary intervention.
Why the study?
Does triple antiplatelet therapy (cilostazol, aspirin, clopidogrel) increase the risk of major bleeding compared to dual antiplatelet therapy in CAD patients undergoing PCI?
Meta-Analysis (n=8,589)
Does triple antiplatelet therapy (cilostazol, aspirin, clopidogrel) increase the risk of major bleeding compared to dual antiplatelet therapy in CAD patients undergoing PCI?
Relative Risk: 1.23 (95% CI 0.9–1.67)
Absolute Event Rate: 2.22% vs 1.51%
p-value: p=0.19
In a meta-analysis of 7 RCTs, adding cilostazol to DAPT did not significantly increase the risk of major bleeding in CAD patients undergoing PCI.
No significant major bleeding increase with cilostazol TAT supports its consideration post-PCI; confirms safety across RCTs.
BACKGROUND: A novel cilostazol-based triple antiplatelet therapy (TAT) was shown in a trial to have a lower restenosis rate than the usual clopidogrel and aspirin dual antiplatelet therapy (DAPT) among patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention. However, TAT may also be associated with an increased risk of bleeding. A systematic review would show further evidence regarding the risk of bleeding among TAT-treated patients. MAIN OBJECTIVE: To determine the risk of bleeding with TAT composed of cilostazol, aspirin and clopidogrel for CAD patients who underwent percutaneous coronary intervention. METHODS: This systematic review included randomized controlled trials (RCT) published from 2005 to 2014. Only one study was blinded. These studies compared the risk of major bleeding between DAPT and TAT. Meta-analysis of this outcome was conducted using Review Manager (RevMan) Version 5.3 2014. RESULTS: The overall relative risk (RR) of major bleeding in TAT patients was 1.23 (CI 95% 0.90, 1.67; z=1.30, p=0.19). The heterogeneity of results of the seven studies was not statistically significant (p=0.88; I2=0%). When isolating those studies with favorable outcome with TAT, the risk of bleeding demonstrated in five studies was also not statistically significant (p=0.11; I2=0%). Sensitivity analysis on two studies with wider deviation and slightly lower rates of bleeding showed no significant influence on the risk of bleeding (RR 0.78; CI 0.29, 2.09; p=0.63; I2=0%). CONCLUSION: Compared with DAPT, the trend towards increased major bleeding in cilostazol -based TAT did not reach statistical significance.
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Keuffel Caparuzo Dangazo (2017) conducted a meta-analysis in Coronary artery disease post-percutaneous coronary intervention (n=8,589). Triple antiplatelet therapy (cilostazol, aspirin, clopidogrel) vs. Dual antiplatelet therapy (aspirin, clopidogrel) was evaluated on Major bleeding (RR 1.23, 95% CI 0.90-1.67, p=0.19). Cilostazol-based triple antiplatelet therapy did not significantly increase the risk of major bleeding compared to dual antiplatelet therapy (RR 1.23) in patients with coronary artery disease undergoing percutaneous coronary intervention.
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