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A randomized clinical trial comparing long-term clopidogrel vs aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the Harmonizing Optimal Strategy for Treatment of coronary artery stenosis-Extended Antiplatelet Monotherapy (HOST-EXAM) trial - 18/04/17

Doi : 10.1016/j.ahj.2016.12.001 
Heesun Lee, MD a, b, 1, Bon-Kwon Koo, MD, PhD a, c, 1, Kyung Woo Park, MD, PhD a, c, Eun-Seok Shin, MD, PhD d, Sang Wook Lim, MD, PhD e, Seung-Woon Rha, MD, PhD f, Jang-Whan Bae, MD, PhD g, Dong Woon Jeon, MD, PhD h, Seok-Kyu Oh, MD, PhD i, Seung-Ho Hur, MD, PhD j, Bum-Su Kim, MD, PhD k, Jung-Hee Lee, MD, PhD l, Tae-Ho Park, MD, PhD m, Nam Ho Lee, MD, PhD n, Hyo-Soo Kim, MD, PhD a, c,
on behalf of the

HOST-EXAM investigators

a Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea 
b Healthcare System Gangnam Center, Seoul National University Hospital, Seoul, Republic of Korea 
c Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea 
d Ulsan University Hospital, Ulsan, Republic of Korea 
e CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea 
f Korea University Guro Hospital, Seoul, Republic of Korea 
g Chungbuk National University, College of Medicine, Cheongju, Republic of Korea 
h National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea 
i Wonkwang University Hospital, Iksan, Republic of Korea 
j Keimyung University Dongsan Medical Center, Daegu, Republic of Korea 
k Kangbuk Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea 
l Yeungnam University Medical Center, Daegu, Republic of Korea 
m Dong-A University Hospital, Busan, Republic of Korea 
n Kangnam Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea 

Reprint requests: Hyo-Soo Kim, MD, PhD, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul 110-744, Republic of Korea.Department of Internal Medicine, Cardiovascular CenterSeoul National University Hospital101 Daehak-ro, Jongro-guSeoul110-744Republic of Korea

Background

Percutaneous coronary intervention (PCI) has been developed by drug-eluting stent (DES), but stent implantation has brought the issue of stent thrombosis and optimal antiplatelet therapy. Guidelines recommend at least 6- to 12 months of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor such as clopidogrel. Beyond DAPT after PCI with DES, however, there has been still a debate for antiplatelet regimen. Therefore, we report on the upcoming HOST-EXAM trial (NCT02044250), which will evaluate the efficacy and safety of aspirin and clopidogrel monotherapies beyond DAPT after DES implantation.

Trial design

The HOST-EXAM is a prospective, randomized, open-label, multicenter, comparative effectiveness trial, to compare between clopidogrel (75 mg once daily) and aspirin (100 mg once daily) as long-term antiplatelet agents. A total of 5,530 patients with no clinical events during combined antiplatelet therapy for 12±6 months after index PCI will be screened, enrolled, and randomized to either group (1:1 ratio) receiving antiplatelet monotherapy for 2 years. The primary endpoint will be the rate of clinical events defined as a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, or major bleeding at 24 months after randomization.

Conclusions

The HOST-EXAM will be the first large-scale randomized controlled study to directly compare the efficacy and safety of long-term antiplatelet monotherapy beyond DAPT after DES implantation. This study will provide clinical evidence to establish optimal regimen for long-term antiplatelet therapy after DES implantation.

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 This study was supported by a grant from the Korean Health Technology R&D Project, Ministry of Health and Welfare, Republic of Korea (HI14C1277). This project is investigator-initiated and funded by an unrestricted grant from Chong Kun Dang Pharmaceutical Corp; Samjin Pharmaceutical Co, Ltd; HANMI PHARMA Co, Ltd; and Daewoong Pharmaceutical Co, Ltd.
 Clinical trials registration number: NCT02044250.


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