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 Moon; Hyuck Moon Kwon; In Ho Chae

doi: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)

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

Internal Medicine

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34 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 language	English
Pages (from-to)	932-942
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	6
Issue number	9
DOIs	https://doi.org/10.1016/j.jcin.2013.04.022
Publication status	Published - 2013 Sept

Bibliographical note

Funding Information:
This study was supported by a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( A062260 ), sponsored by the Ministry of Health and Welfare, Republic of Korea. The authors also received an unrestricted grant from Boston Scientific Korea . The funding sources of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the paper. Drs. Park and Kang contributed equally to this study.

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Cardiology and Cardiovascular Medicine

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Kim, H. S., Park, K. W., Kang, S. H., Park, J. J., Yang, H. M., Kang, H. J., Koo, B. K., Park, B. E., Cha, K. S., Rhew, J. Y., Jeon, H. K., Shin, E. S., Oh, J. H., Jeong, M. H., Kim, S., Hwang, K. K., Yoon, J. H., Lee, S. Y., Park, T. H., ... Chae, I. H. (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, 6(9), 932-942. https://doi.org/10.1016/j.jcin.2013.04.022

Kim, Hyo Soo ; Park, Kyung Woo ; Kang, Si Hyuck et al. / 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.

@article{2b45ee607d6247aeb498b342a1fede26,

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}",

note = "Funding Information: This study was supported by a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( A062260 ), sponsored by the Ministry of Health and Welfare, Republic of Korea. The authors also received an unrestricted grant from Boston Scientific Korea . The funding sources of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the paper. Drs. Park and Kang contributed equally to this study. ",

year = "2013",

month = sep,

doi = "10.1016/j.jcin.2013.04.022",

language = "English",

volume = "6",

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 et al.

In: JACC: Cardiovascular Interventions, Vol. 6, No. 9, 09.2013, p. 932-942.

Research output: Contribution to journal › Article › peer-review

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

N1 - Funding Information: This study was supported by a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( A062260 ), sponsored by the Ministry of Health and Welfare, Republic of Korea. The authors also received an unrestricted grant from Boston Scientific Korea . The funding sources of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the paper. Drs. Park and Kang contributed equally to this study.

PY - 2013/9

Y1 - 2013/9

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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Kim HS, Park KW, Kang SH, Park JJ, Yang HM, Kang HJ et al. 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. 2013 Sept;6(9):932-942. doi: 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)

Abstract

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