The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: Study protocol for a randomized controlled trial

Kyung W. Park, Byoung Eun Park, Si Hyuck Kang, Jin Joo Park, Seung Pyo Lee, Kwang S. Cha, Jay Y. Rhew, Hui Kyoung Jeon, Eun S. Shin, Ju H. Oh, Myung Ho Jeong, Sanghyun Kim, Kyung Kuk Hwang, Jung Han Yoon, Sung Y. Lee, Tae Ho Park, Keon W. Moon, Hyuck Moon Kwon, In Ho Chae, Hyo Soo Kim

Research output: Contribution to journalArticle

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Abstract

Background: Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.Methods: In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.Discussion: The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.Trial registration: ClincalTrials.gov number NCT01267734.

Original languageEnglish
Article number29
JournalTrials
Volume13
DOIs
Publication statusPublished - 2012 Mar 31

Fingerprint

Drug-Eluting Stents
Coronary Stenosis
Clinical Protocols
Stents
Randomized Controlled Trials
Chromium
Safety
clopidogrel
Platinum
Percutaneous Coronary Intervention
Cobalt
Chromium Alloys
Therapeutics
Acute Coronary Syndrome
Korea

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Park, Kyung W. ; Park, Byoung Eun ; Kang, Si Hyuck ; Park, Jin Joo ; Lee, Seung Pyo ; Cha, Kwang S. ; Rhew, Jay Y. ; Jeon, Hui Kyoung ; Shin, Eun S. ; Oh, Ju H. ; Jeong, Myung Ho ; Kim, Sanghyun ; Hwang, Kyung Kuk ; Yoon, Jung Han ; Lee, Sung Y. ; Park, Tae Ho ; Moon, Keon W. ; Kwon, Hyuck Moon ; Chae, In Ho ; Kim, Hyo Soo. / The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial : Study protocol for a randomized controlled trial. In: Trials. 2012 ; Vol. 13.
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title = "The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: Study protocol for a randomized controlled trial",
abstract = "Background: Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.Methods: In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.Discussion: The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.Trial registration: ClincalTrials.gov number NCT01267734.",
author = "Park, {Kyung W.} and Park, {Byoung Eun} and Kang, {Si Hyuck} and Park, {Jin Joo} and Lee, {Seung Pyo} and Cha, {Kwang S.} and Rhew, {Jay Y.} and Jeon, {Hui Kyoung} and Shin, {Eun S.} and Oh, {Ju H.} and Jeong, {Myung Ho} and Sanghyun Kim and Hwang, {Kyung Kuk} and Yoon, {Jung Han} and Lee, {Sung Y.} and Park, {Tae Ho} and Moon, {Keon W.} and Kwon, {Hyuck Moon} and Chae, {In Ho} and Kim, {Hyo Soo}",
year = "2012",
month = "3",
day = "31",
doi = "10.1186/1745-6215-13-29",
language = "English",
volume = "13",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

Park, KW, Park, BE, Kang, SH, Park, JJ, Lee, SP, 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 & Kim, HS 2012, 'The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: Study protocol for a randomized controlled trial', Trials, vol. 13, 29. https://doi.org/10.1186/1745-6215-13-29

The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial : Study protocol for a randomized controlled trial. / Park, Kyung W.; Park, Byoung Eun; Kang, Si Hyuck; Park, Jin Joo; Lee, Seung Pyo; Cha, Kwang S.; Rhew, Jay Y.; Jeon, Hui Kyoung; Shin, Eun S.; Oh, Ju H.; Jeong, Myung Ho; Kim, Sanghyun; Hwang, Kyung Kuk; Yoon, Jung Han; Lee, Sung Y.; Park, Tae Ho; Moon, Keon W.; Kwon, Hyuck Moon; Chae, In Ho; Kim, Hyo Soo.

In: Trials, Vol. 13, 29, 31.03.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial

T2 - Study protocol for a randomized controlled trial

AU - Park, Kyung W.

AU - Park, Byoung Eun

AU - Kang, Si Hyuck

AU - Park, Jin Joo

AU - Lee, Seung Pyo

AU - Cha, Kwang S.

AU - Rhew, Jay Y.

AU - Jeon, Hui Kyoung

AU - Shin, Eun S.

AU - Oh, Ju H.

AU - Jeong, Myung Ho

AU - Kim, Sanghyun

AU - Hwang, Kyung Kuk

AU - Yoon, Jung Han

AU - Lee, Sung Y.

AU - Park, Tae Ho

AU - Moon, Keon W.

AU - Kwon, Hyuck Moon

AU - Chae, In Ho

AU - Kim, Hyo Soo

PY - 2012/3/31

Y1 - 2012/3/31

N2 - Background: Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.Methods: In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.Discussion: The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.Trial registration: ClincalTrials.gov number NCT01267734.

AB - Background: Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.Methods: In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.Discussion: The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.Trial registration: ClincalTrials.gov number NCT01267734.

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