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Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial.

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Title: Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial.
Authors: Koo, Bon-Kwon (AUTHOR), Kang, Jeehoon (AUTHOR), Park, Kyung Woo (AUTHOR), Rhee, Tae-Min (AUTHOR), Yang, Han-Mo (AUTHOR), Won, Ki-Bum (AUTHOR), Rha, Seung-Woon (AUTHOR), Bae, Jang-Whan (AUTHOR), Lee, Nam Ho (AUTHOR), Hur, Seung-Ho (AUTHOR), Yoon, Junghan (AUTHOR), Park, Tae-Ho (AUTHOR), Kim, Bum Soo (AUTHOR), Lim, Sang Wook (AUTHOR), Cho, Yoon Haeng (AUTHOR), Jeon, Dong Woon (AUTHOR), Kim, Sang-Hyun (AUTHOR), Han, Jung-Kyu (AUTHOR), Shin, Eun-Seok (AUTHOR), Kim, Hyo-Soo (AUTHOR)
Source: Lancet. 6/26/2021, Vol. 397 Issue 10293, p2487-2496. 10p.
Subjects: Percutaneous coronary intervention, Drug-eluting stents, Aspirin, Platelet aggregation inhibitors, Acute coronary syndrome, Clopidogrel, Research, Medical care, Evaluation research, Cardiovascular system, Comparative studies, Randomized controlled trials, Coronary artery disease, Longitudinal method
Geographic Terms: South Korea
Abstract: Background: Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and clopidogrel monotherapy in this population.Methods: We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6-18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. 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 (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250.Findings: Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 [49·8%]) or to the aspirin group (2728 [50·2%]). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 [95% CI 0·59-0·90]; p=0·0035).Interpretation: Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events.Funding: ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial.
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  Data: <searchLink fieldCode="AR" term="%22Koo%2C+Bon-Kwon%22">Koo, Bon-Kwon</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kang%2C+Jeehoon%22">Kang, Jeehoon</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Park%2C+Kyung+Woo%22">Park, Kyung Woo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rhee%2C+Tae-Min%22">Rhee, Tae-Min</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yang%2C+Han-Mo%22">Yang, Han-Mo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Won%2C+Ki-Bum%22">Won, Ki-Bum</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rha%2C+Seung-Woon%22">Rha, Seung-Woon</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bae%2C+Jang-Whan%22">Bae, Jang-Whan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lee%2C+Nam+Ho%22">Lee, Nam Ho</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hur%2C+Seung-Ho%22">Hur, Seung-Ho</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yoon%2C+Junghan%22">Yoon, Junghan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Park%2C+Tae-Ho%22">Park, Tae-Ho</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kim%2C+Bum+Soo%22">Kim, Bum Soo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lim%2C+Sang+Wook%22">Lim, Sang Wook</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cho%2C+Yoon+Haeng%22">Cho, Yoon Haeng</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Jeon%2C+Dong+Woon%22">Jeon, Dong Woon</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kim%2C+Sang-Hyun%22">Kim, Sang-Hyun</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Han%2C+Jung-Kyu%22">Han, Jung-Kyu</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Shin%2C+Eun-Seok%22">Shin, Eun-Seok</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kim%2C+Hyo-Soo%22">Kim, Hyo-Soo</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 6/26/2021, Vol. 397 Issue 10293, p2487-2496. 10p.
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  Data: <searchLink fieldCode="DE" term="%22Percutaneous+coronary+intervention%22">Percutaneous coronary intervention</searchLink><br /><searchLink fieldCode="DE" term="%22Drug-eluting+stents%22">Drug-eluting stents</searchLink><br /><searchLink fieldCode="DE" term="%22Aspirin%22">Aspirin</searchLink><br /><searchLink fieldCode="DE" term="%22Platelet+aggregation+inhibitors%22">Platelet aggregation inhibitors</searchLink><br /><searchLink fieldCode="DE" term="%22Acute+coronary+syndrome%22">Acute coronary syndrome</searchLink><br /><searchLink fieldCode="DE" term="%22Clopidogrel%22">Clopidogrel</searchLink><br /><searchLink fieldCode="DE" term="%22Research%22">Research</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+care%22">Medical care</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation+research%22">Evaluation research</searchLink><br /><searchLink fieldCode="DE" term="%22Cardiovascular+system%22">Cardiovascular system</searchLink><br /><searchLink fieldCode="DE" term="%22Comparative+studies%22">Comparative studies</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Coronary+artery+disease%22">Coronary artery disease</searchLink><br /><searchLink fieldCode="DE" term="%22Longitudinal+method%22">Longitudinal method</searchLink>
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  Data: <bold>Background: </bold>Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and clopidogrel monotherapy in this population.<bold>Methods: </bold>We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6-18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. 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 (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250.<bold>Findings: </bold>Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 [49·8%]) or to the aspirin group (2728 [50·2%]). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 [95% CI 0·59-0·90]; p=0·0035).<bold>Interpretation: </bold>Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events.<bold>Funding: </bold>ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1016/S0140-6736(21)01063-1
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