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

被引：8

作者：

Park, Kyung Woo ^{[2
]}

Park, Byoung-Eun ^{[3
]}

Kang, Si-Hyuck ^{[2
]}

Park, Jin-Joo ^{[2
]}

Lee, Seung-Pyo ^{[2
]}

Cha, Kwang Soo ^{[4
]}

Rhew, Jay Young ^{[5
]}

Jeon, Hui-Kyoung ^{[6
]}

Shin, Eun Seok ^{[7
]}

Oh, Ju Hyeon ^{[8
]}

Jeong, Myung-Ho ^{[9
]}

Kim, Sanghyun ^{[10
]}

Hwang, Kyung-Kuk ^{[11
]}

Yoon, Jung-Han ^{[12
]}

Lee, Sung Yun ^{[13
]}

Park, Tae-Ho ^{[14
]}

Moon, Keon Woong ^{[15
]}

Kwon, Hyuck-Moon ^{[16
]}

Chae, In-Ho ^{[1
]}

Kim, Hyo-Soo ^{[2
]}

机构：

[1] Seoul Natl Univ, Bundang Hosp, Songnam, South Korea

[2] Seoul Natl Univ Hosp, Dept Internal Med, Cardiovasc Ctr, Seoul 110744, South Korea

[3] Dankook Univ Hosp, Cheonan, South Korea

[4] Busan Natl Univ Hosp, Pusan, South Korea

[5] Presbyterian Med Ctr, Jeonju, South Korea

[6] Uijeongbu St Marys Hosp, Uijongbu, South Korea

[7] Ulsan Univ Hosp, Ulsan, South Korea

[8] Samsung Changwon Hosp, Chang Won, South Korea

[9] Chonnam Natl Univ Hosp, Kwangju, South Korea

[10] Boramae Med Ctr, Seoul, South Korea

[11] Chungbuk Natl Univ Hosp, Cheongju, South Korea

[12] Wonju Christian Hosp, Wonju, South Korea

[13] Inje Univ, Ilsan Paik Hosp, Goyang, South Korea

[14] Dong A Med Ctr, Pusan, South Korea

[15] St Vincents Hosp, Suwon, South Korea

[16] Gangnam Severance Hosp, Seoul, South Korea

来源：

TRIALS | 2012年 / 13卷

关键词：

Cilostazol; cobalt chromium; coronary heart disease; everolimus-eluting stent; platinum chromium; zotarolimus-eluting stent; REDUCES LATE RESTENOSIS; OF-CARE ASSAY; PLATELET REACTIVITY; CLOPIDOGREL; INTERVENTION; IMPLANTATION; OUTCOMES; THERAPY; METAANALYSIS; CILOSTAZOL;

D O I：

10.1186/1745-6215-13-29

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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 x 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.

引用

页数：8

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