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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

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 ch...

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Autores principales: Park, Kyung Woo, Park, Byoung-Eun, Kang, Si-Hyuck, Park, Jin-Joo, Lee, Seung-Pyo, 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, Kim, Hyo-Soo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3342216/
https://www.ncbi.nlm.nih.gov/pubmed/22463698
http://dx.doi.org/10.1186/1745-6215-13-29
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author Park, Kyung Woo
Park, Byoung-Eun
Kang, Si-Hyuck
Park, Jin-Joo
Lee, Seung-Pyo
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
Kim, Hyo-Soo
author_facet Park, Kyung Woo
Park, Byoung-Eun
Kang, Si-Hyuck
Park, Jin-Joo
Lee, Seung-Pyo
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
Kim, Hyo-Soo
author_sort Park, Kyung Woo
collection PubMed
description 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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spelling pubmed-33422162012-05-03 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 Woo Park, Byoung-Eun Kang, Si-Hyuck Park, Jin-Joo Lee, Seung-Pyo 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 Kim, Hyo-Soo Trials Study Protocol 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. BioMed Central 2012-03-31 /pmc/articles/PMC3342216/ /pubmed/22463698 http://dx.doi.org/10.1186/1745-6215-13-29 Text en Copyright ©2012 Park et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Park, Kyung Woo
Park, Byoung-Eun
Kang, Si-Hyuck
Park, Jin-Joo
Lee, Seung-Pyo
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
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort '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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3342216/
https://www.ncbi.nlm.nih.gov/pubmed/22463698
http://dx.doi.org/10.1186/1745-6215-13-29
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