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Lancet, Mar 29 2026, S0140-6736(26)00422-8 | https://doi.org/10.1016/S0140-6736(26)00422-8 Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention: 10-year follow-up of the HOST-EXAM trial

Jeehoon Kang MD PhD ^a*, Sungjoon Park MD ^b*, Han-Mo Yang MD PhD ^c*, Eun-Seok Shin MD PhD ^d, Seung-Woon Rha MD PhD ^e, Jang-Whan Bae MD PhD ^f, Nam Ho Lee MD PhD ^g, Hyuck-Jun Yoon MD PhD ^h, Yoon Haeng Cho MD PhD ⁱ, Ung Kim MD PhD ^j, Song-Yi Kim MD PhD ^k, Sang-Hyun Kim MD PhD ^b, Jung-Kyu Han MD PhD ^a, Prof Kyung Woo Park MD PhD ^c, Prof Hyo-Soo Kim MD PhD ^l on behalf of the HOST-EXAM investigators

^aDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea
^bDepartment of Cardiovascular Medicine, Boramae Medical Center, Seoul, South Korea
^cDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea
^dDepartment of Cardiovascular Medicine, Ulsan University Hospital, Ulsan, South Korea
^eDepartment of Cardiovascular Medicine, Korea University Guro Hospital, Seoul, South Korea
^fDepartment of Cardiovascular Medicine, Good SamSun Hospital, Busan, South Korea
^gDepartment of Cardiovascular Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, South Korea
^hDepartment of Cardiovascular Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea
ⁱDepartment of Cardiovascular Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea
^jDepartment of Cardiovascular Medicine, Yeungnam University Medical Center, Daegu, South Korea
^kDepartment of Cardiovascular Medicine, Jeju National University Hospital, Jeju, South Korea
^lBiomedical Research Institute, Seoul National University Hospital, Seoul, South Korea

^*Contributed equally
Correspondence to: Prof Hyo-Soo Kim, Kyung Woo Park

Abstract

Background: The long-term clinical outcomes of clopidogrel monotherapy versus aspirin monotherapy after percutaneous coronary intervention (PCI) remain uncertain. We conducted a 10-year follow-up of the HOST-EXAM trial to assess the very long-term effects of clopidogrel versus aspirin monotherapy in this setting.

Methods: In HOST-EXAM, patients who had completed dual antiplatelet therapy without clinical events for 6-18 months after PCI were randomly assigned to receive clopidogrel 75 mg once daily or aspirin 100 mg once daily. This study is an investigator-initiated 10-year extended follow-up of the HOST-EXAM trial. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium type ≥3 bleeding. The primary analysis was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov (NCT02044250) and is complete.

Findings: From March 26, 2014, to May 29, 2018, 5530 patients were enrolled and 5438 were randomly assigned to the aspirin group (n=2728) or the clopidogrel group (n=2710). Clinical follow-up status was ascertained on May 1, 2025, resulting in a median follow-up duration of 10·5 years (IQR 9·4-11·4) after PCI and a completion rate of 92·8%. Clopidogrel was associated with a lower rate of the primary composite endpoint than aspirin (Kaplan-Meier estimate 25·4% for the clopidogrel group vs 28·5% for the aspirin group; hazard ratio 0·86 [95% CI 0·77-0·96]; log-rank p=0·0050). Clopidogrel was also associated with a lower rate of the thrombotic endpoint (17·3% vs 20·0%; log-rank p=0·0024) and bleeding endpoint (9·1% vs 10·8%; log-rank p=0·020). All-cause mortality was similar between groups.

Interpretation: During 10 years of follow-up, clopidogrel monotherapy, compared with aspirin monotherapy, was associated with lower rates of the primary composite, ischaemic, and bleeding outcomes, but not all-cause mortality after PCI. These findings support consideration of clopidogrel as an alternative to aspirin for long-term antiplatelet monotherapy during the chronic maintenance phase after PCI.

논문소개전체 설명

관상동맥 협착증에 대해서 스텐트 삽입술 이후 약 1년간 이중 항혈소판요법을 유지해야하며, 이후 유지 용법으로 단일 항혈소판제를 사용하는 것이 치료원칙이다. 단일 항혈소판 약제로서 클로피도그렐은 HOST-EXAM 연구와 SMART-CHOICE3 연구 등 여러 임상연구 결과를 통해서 기존의 일차 선택약제였던 아스피린과 동등한 위상의 약제가 되었다. 다만, 단일 항혈소판제를 평생동안 장기간 유지해야하는 약제임을 고려하면 두 가지 약제를 비교한 장기간 추적관찰 결과가 필수적이다.
 본 연구는 HOST-EXAM 연구의 장기간 추적관찰 연구이다. HOST-EXAM 연구는 한국 내 37개 기관에서 경피적 관상동맥 중재술 이후에 안정화된 환자들을 클로피도그렐군(2710명)과 아스피린군(2728명)으로 무작위 배정한 연구로, 본 연구에서의 추적관찰 기간은 중위값 10.5년 (사분위간 범위, 9.4년과 11.4년) 이었다. 연구의 1차 종결점은 모든 원인 사망, 비치명적 심근경색, 뇌졸중, 급성 관상동맥 증후군으로 인한 재입원, 주요 출혈(BARC 기준 3 혹은 5)의 복합 사건으로 정의되었으며, HOST-EXAM 연구의 1차 종결점 판단 시점은 2년 추적관찰 시점 이후에는 개방형 추적관찰을 하였다.
 연구 결과, 클로피도그렐군은 아스피린군 대비 일차 종결점 발생률이 유의하게 낮았으며 (25.4% vs 28.5%, HR 0.86, p=0.0050), 혈전성 복합 종결점 (17.3% vs 20.0%, p=0.0024) 및 모든 출혈 종결점 (9.1% vs 10.8%, p=0.020)에서도 클로피도그렐이 적게 발생하였다. 두 집단 간 사망률은 유의한 차이가 없었다.

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