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)

Hyo Soo Kim, 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 Kuk Hwang, Jung Han Yoon, Sung Yun Lee, Tae Ho Park, Keon Woong MoonHyuck Moon Kwon, In Ho Chae

Research output: Contribution to journalArticle

27 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)932-942
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume6
Issue number9
DOIs
Publication statusPublished - 2013 Sep 1

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clopidogrel
Drug-Eluting Stents
Coronary Stenosis
Blood Platelets
Safety
Percutaneous Coronary Intervention
Therapeutics
Stents
cilostazol
Thrombosis
Stroke
Myocardial Infarction
Confidence Intervals
Hemorrhage

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Kim, Hyo Soo ; Park, Kyung Woo ; Kang, Si Hyuck ; Park, Jin Joo ; Yang, Han Mo ; Kang, Hyun Jae ; Koo, Bon Kwon ; Park, Byoung Eun ; Cha, Kwang Soo ; Rhew, Jay Young ; Jeon, Hui Kyoung ; Shin, Eun Seok ; Oh, Ju Hyeon ; Jeong, Myung Ho ; Kim, Sanghyun ; Hwang, Kyung Kuk ; Yoon, Jung Han ; Lee, Sung Yun ; Park, Tae Ho ; Moon, Keon Woong ; Kwon, Hyuck Moon ; Chae, In Ho. / 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). In: JACC: Cardiovascular Interventions. 2013 ; Vol. 6, No. 9. pp. 932-942.
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title = "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)",
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).",
author = "Kim, {Hyo Soo} and Park, {Kyung Woo} and Kang, {Si Hyuck} and Park, {Jin Joo} and Yang, {Han Mo} and Kang, {Hyun Jae} and Koo, {Bon Kwon} and Park, {Byoung Eun} and Cha, {Kwang Soo} and Rhew, {Jay Young} and Jeon, {Hui Kyoung} and Shin, {Eun Seok} and Oh, {Ju Hyeon} and Jeong, {Myung Ho} and Sanghyun Kim and Hwang, {Kyung Kuk} and Yoon, {Jung Han} and Lee, {Sung Yun} and Park, {Tae Ho} and Moon, {Keon Woong} and Kwon, {Hyuck Moon} and Chae, {In Ho}",
year = "2013",
month = "9",
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doi = "10.1016/j.jcin.2013.04.022",
language = "English",
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pages = "932--942",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "9",

}

Kim, HS, Park, KW, Kang, SH, Park, JJ, Yang, HM, Kang, HJ, Koo, BK, Park, BE, Cha, KS, Rhew, JY, Jeon, HK, Shin, ES, Oh, JH, Jeong, MH, Kim, S, Hwang, KK, Yoon, JH, Lee, SY, Park, TH, Moon, KW, Kwon, HM & Chae, IH 2013, '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)', JACC: Cardiovascular Interventions, vol. 6, no. 9, pp. 932-942. https://doi.org/10.1016/j.jcin.2013.04.022

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

In: JACC: Cardiovascular Interventions, Vol. 6, No. 9, 01.09.2013, p. 932-942.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation

T2 - The HOST-ASSURE randomized trial (Harmonizing Optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen)

AU - Kim, Hyo Soo

AU - Park, Kyung Woo

AU - Kang, Si Hyuck

AU - Park, Jin Joo

AU - Yang, Han Mo

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Park, Byoung Eun

AU - Cha, Kwang Soo

AU - Rhew, Jay Young

AU - Jeon, Hui Kyoung

AU - Shin, Eun Seok

AU - Oh, Ju Hyeon

AU - Jeong, Myung Ho

AU - Kim, Sanghyun

AU - Hwang, Kyung Kuk

AU - Yoon, Jung Han

AU - Lee, Sung Yun

AU - Park, Tae Ho

AU - Moon, Keon Woong

AU - Kwon, Hyuck Moon

AU - Chae, In Ho

PY - 2013/9/1

Y1 - 2013/9/1

N2 - 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).

AB - 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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