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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2012
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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. |
format | Online Article Text |
id | pubmed-3342216 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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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