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
Dr Lee and Dr Koo contributed equally to this work.}}, Bon-Kwon Koo, MD, PhD ^a,^c,^{^{1
Dr Lee and Dr Koo contributed equally to this work.}}, 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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Plan

Background

Study design and methods

Study objectives

Study population

Study design

Randomization and interventions with study drugs

Outcome measurement

Statistical analysis

Trial organization and ethical considerations

Discussion

The necessity of trials providing strong evidence for the best antiplatelet monotherapy beyond DAPT after DES implantation

The best therapeutic agent for long-term antiplatelet monotherapy

Which drug increases bleeding risk?

Conclusion

	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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