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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

Authors
 Kyung Woo Park ; Byoung-Eun Park ; Hyo-Soo Kim ; In-Ho Chae ; Hyuck-Moon Kwon ; Keon Woong Moon ; Tae-Ho Park ; Sung Yun Lee ; Jung-Han Yoon ; Kyung-Kuk Hwang ; Sanghyun Kim ; Myung-Ho Jeong ; Ju Hyeon Oh ; Eun Seok Shin ; Hui-Kyoung Jeon ; Jay Young Rhew ; Kwang Soo Cha ; Seung-Pyo Lee ; Jin-Joo Park ; Si-Hyuck Kang 
Citation
 Trials, Vol.13(null) : 29, 2012 
Journal Title
 Trials 
ISSN
 1745-6215 
Issue Date
2012
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.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/91980
DOI
10.1186/1745-6215-13-29
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Internal Medicine
Yonsei Authors
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