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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 
Journal Title
Issue Date
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
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
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).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Hyuck Moon(권혁문) ORCID logo https://orcid.org/0000-0001-9901-5015
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