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.
Bibliographical noteFunding Information:
This is a prospective, randomized, single blind, blinded endpoint evaluation, multicenter trial with a 2 × 2 factorial design. The study algorithm is shown in Figure 1. After enrollment and index PCI procedure, clinical follow-up will occur at 1, 3, 12 months and yearly up to 3 years after intervention. Follow-ups will be conducted as telephone contacts or office visits. Unless clinically necessary, there will be no angiographic follow-up until 12 months post PCI, the timepoint for the primary endpoint of the stent comparison. In a subset of patients angiographic follow-up will be recommended at 13 months post PCI. In another subgroup of patients, clopidogrel on-treatment platelet reactivity will be measured using the VerifyNow P2Y12 assay at baseline PCI and at 1-month follow-up. This study is an investigator-initiated clinical trial with grant support from two sources, the Ministry of Health, Welfare, and Family Affairs of the Republic of Korea, and Boston Scientific Korea. Other than providing financial support, Boston Scientific was not involved with the protocol development or the study process, including site selection, management, and data collection and analysis. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.
The overall trial organization is summarized in Additional file 2: Appendix C. The trial was designed by the principal investigators and the executive committee. Besides the executive committee, the steering committee, data safety monitoring board, and the clinical event adjudication committee will be involved in the execution, administration, and supervision of the trial. The specific role and information regarding each of the committees appear in Additional file 2: Appendix C. The study will be sponsored by the Seoul National University Hospital (SNUH) Cardiovascular Clinical Research Center (CCRC) and the data will be managed by an independent contract research organization, Dream CIS Inc. Dream CIS will be responsible for the development of a web-based randomization system, maintenance of the web-based case report form, and data collection from individual sites. Site monitoring will be performed by the CCRC of SNUH. The trial monitors will review the documents of at least 30% of the patients enrolled from each participating center, at appropriate intervals, for accuracy and completeness and to ensure compliance with the protocol. The trial monitor will be able to inspect all documents and required records that are maintained by the individual investigator and site, including medical records (office, clinic, or hospital) for the subjects in this trial. The study will be performed in accordance with the Declaration of Helsinki. Before participation of the study, each patient will be given full information, that is, purpose, methods, rights, duties and possible risk/benefits of the study in plain, lay language. Written, informed consent is a prerequisite to the participation in the study.
We thank Tae-Eun Kim, RN for her devotion and efforts in initiating the trial. H-SK is also a professor of Molecular Medicine and Biopharmaceuticals Sciences, Seoul National University, sponsored by World Class University (WCU) program from the Ministry of Education and Science, Korea. This study was supported by a grant from the Clinical Research Center for Ischemic Heart Disease, Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea (A102065), and a grant from the Innovative Research Institute for Cell Therapy, Seoul National University Hospital (A062260), sponsored by the Ministry of Health and Welfare, Republic of Korea. The authors also received an unrestricted grant from Boston Scientific Korea. The funding sources had no role in study design or the writing of this manuscript.
All Science Journal Classification (ASJC) codes
- Medicine (miscellaneous)
- Pharmacology (medical)