Adjunctive Cilostazol Versus Double-Dose Clopidogrel After Drug-Eluting Stent Implantation

Kyung Woo Park; Si-Hyuck Kang; Jin Joo Park; Han-Mo Yang; Hyun-Jae Kang; Bon-Kwon Koo; Byoung-Eun Park; Kwang Soo Cha; Jay Young Rhew; Hui-Kyoung Jeon; Eun Seok Shin; Ju Hyeon Oh; Myung-Ho Jeong; Sanghyun Kim; Kyung-KukHwang; Jung-Han Yoon; Sung Yun Lee; Tae-Ho Park; Keon Woong Moon; Hyuck-Moon Kwon; In-Ho Chae; Hyo-Soo Kim

doi:10.1016/j.jcin.2013.04.022

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Adjunctive Cilostazol Versus Double-Dose Clopidogrel After Drug-Eluting Stent Implantation

Authors: Kyung Woo Park ; Si-Hyuck Kang ; Jin Joo Park ; Han-Mo Yang ; Hyun-Jae Kang ; Bon-Kwon Koo ; Byoung-Eun Park ; Kwang Soo Cha ; Jay Young Rhew ; Hui-Kyoung Jeon ; Eun Seok Shin ; Ju Hyeon Oh ; Myung-Ho Jeong ; Sanghyun Kim ; Kyung-KukHwang ; Jung-Han Yoon ; Sung Yun Lee ; Tae-Ho Park ; Keon Woong Moon ; Hyuck-Moon Kwon ; In-Ho Chae ; Hyo-Soo Kim

Citation: JACC-CARDIOVASCULAR INTERVENTIONS, Vol.6(9) : 932-942, 2013

Journal Title: JACC-CARDIOVASCULAR INTERVENTIONS

ISSN: 1936-8798

Issue Date: 2013

MeSH: Aged ; Aspirin/administration & dosage ; Coronary Artery Disease/diagnosis ; Coronary Artery Disease/mortality ; Coronary Artery Disease/therapy* ; Coronary Thrombosis/etiology ; Drug Therapy, Combination ; Drug-Eluting Stents* ; Female ; Hemorrhage/chemically induced ; Humans ; Male ; Middle Aged ; Myocardial Infarction/etiology ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/instrumentation* ; Percutaneous Coronary Intervention/mortality ; Platelet Aggregation Inhibitors/administration & dosage* ; Platelet Aggregation Inhibitors/adverse effects ; Prospective Studies ; Prosthesis Design ; Republic of Korea ; Risk Factors ; Stroke/etiology ; Tetrazoles/administration & dosage* ; Tetrazoles/adverse effects ; Ticlopidine/administration & dosage ; Ticlopidine/adverse effects ; Ticlopidine/analogs & derivatives* ; Time Factors ; Treatment Outcome

Keywords: ACS ; CI ; DDAT ; HOPR ; MI ; OPR ; PCI ; TAT ; acute coronary syndromes ; antiplatelet therapy ; cliostazol ; clopidogrel ; confidence interval ; double-dose clopidogrel dual antiplatelet therapy ; high on-treatment platelet reactivity ; myocardial infarction ; on-treatment platelet reactivity ; percutaneous coronary intervention ; randomized controlled trial ; triple antiplatelet therapy

Abstract: OBJECTIVES: This study sought to test the noninferiority of triple antiplatelet therapy (TAT) versus double-dose clopidogrel dual antiplatelet therapy (DDAT) in patients undergoing percutaneous coronary intervention (PCI).

BACKGROUND: Antiplatelet regimen is an integral component of medical therapy after PCI. A 1-week duration of doubling the dose of clopidogrel was shown to improve outcome at 1 month compared with the conventional dose in patients with acute coronary syndrome undergoing PCI. Yet in Asia, the addition of cilostazol is used more commonly than DDAT in high-risk patients.

METHODS: We 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.

RESULTS: 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% confidence interval, p = 0.0007 for noninferiority; hazard ratio: 0.85; 95% confidence interval: 0.49 to 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 2 groups. There were no significant between-group differences in the treatment effect with regard to the rate of the primary outcome.

CONCLUSIONS: 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. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).