Adjunctive Cilostazol Versus Double-Dose Clopidogrel After Drug-Eluting Stent Implantation: The HOST-ASSURE Randomized Trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis–Safety & Effectiveness of Drug-Eluting Stents & Anti-platelet Regimen)
What is the efficacy of triple antiplatelet therapy (TAT) versus double-dose clopidogrel dual antiplatelet therapy (DDAT) in patients undergoing percutaneous coronary intervention (PCI)?
The HOST-ASSURE trial investigators randomly assigned 3,755 all-comers undergoing PCI to either TAT or DDAT, which was continued for 1 month, to test the noninferiority of TAT versus DDAT. The primary outcome was the cumulative incidence of net clinical outcome at 1 month post-PCI defined as the composite of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO (Platelet Inhibition and Patient Outcomes) major bleeding. Time-to-event curves were compared using the log-rank tests. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using the Cox proportional hazards method.
TAT was noninferior to DDAT with respect to the primary outcome, which occurred in 1.2% and 1.4% of patients, respectively (−0.22% absolute difference, 0.34% 1-sided 97.5% CI, p = 0.0007 for noninferiority; HR, 0.85; 95% CI, 0.49-1.48; p = 0.558 for superiority). The individual risks of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO major bleeding did not differ significantly between the two groups. There were no significant between-group differences in the treatment effect with regard to the rate of the primary outcome.
The authors concluded that the adjunctive use of cilostazol was noninferior to doubling the dose of clopidogrel for 1 month in all-comers undergoing PCI with exclusively drug-eluting stents.
This trial reported that the adjunctive use of cilostazol for 1 month in addition to conventional DAPT was noninferior to doubling the maintenance dose of clopidogrel with regard to net clinical outcome. Furthermore, there were no differences between the two treatment regimens regarding the individual components of the primary outcome. Although this study provides some support for triple antiplatelet therapy, the clinical significance of this finding remains uncertain in the era of more potent P2Y12 inhibitors. Further studies with cilostazol that are adequately powered and comparison with DAPT with the newer agents are needed to better determine its viability as an adjunctive antiplatelet therapy in the current management of acute coronary syndrome and PCI.
Keywords: Myocardial Infarction, Stroke, Acute Coronary Syndrome, Platelet Aggregation Inhibitors, Drug-Eluting Stents, Ticlopidine, Tetrazoles, Percutaneous Coronary Intervention, Incidence, Coronary Angiography, Coronary Stenosis, Thrombosis, Organoplatinum Compounds, Confidence Intervals, Hemorrhage
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