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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 :
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
Source :
Trials [Trials] 2012 Mar 31; Vol. 13, pp. 29. Date of Electronic Publication: 2012 Mar 31.
Publication Year :
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.<br />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.<br />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.<br />Trial Registration: ClincalTrials.gov number NCT01267734.

Details

Language :
English
ISSN :
1745-6215
Volume :
13
Database :
MEDLINE
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
22463698
Full Text :
https://doi.org/10.1186/1745-6215-13-29