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

Lee, Heesun; Koo, Bon Kwon; Park, Kyung Woo; Shin, Eun Seok; Lim, Sang Wook; Rha, Seung Woon; Bae, Jang Whan; Jeon, Dong Woon; Oh, Seok Kyu; Hur, Seung Ho; Kim, Bum Su; Lee, Jun Young; Park, Tae Ho; Lee, Nam Ho; Kim, Hyo Soo

doi:10.1016/j.ahj.2016.12.001

Cited by 17 publications

(12 citation statements)

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“…Details on the design of the HOST-EXAM trial have been described previously. 5 Briefly, the HOST-EXAM trial was an investigator-initiated, prospective, randomized, open-labeled, multicenter trial done at 37 study sites in Korea. In March 2020, an extended follow-up was planned, and the study protocol was submitted to the National Evidence-Based Healthcare Collaborating Agency of Korea.…”

Section: Trial Design and Oversightmentioning

confidence: 99%

Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The HOST-EXAM Extended Study

et al. 2023

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Background: Long term outcomes of antiplatelet monotherapy in patients who receive percutaneous coronary intervention (PCI) are unknown. The HOST-EXAM Extended study reports the post-trial follow-up results of the original HOST-EXAM trial. Methods: From March 2014 through May 2018, 5438 patients who maintained dual antiplatelet therapy without clinical events for 12±6 months after PCI with drug-eluting stents (DES) were randomly assigned in a 1:1 ratio to receive clopidogrel 75mg once daily or aspirin 100mg once daily. The primary endpoint (a composite of all-cause death, nonfatal myocardial infarction (MI), stroke, readmission due to acute coronary syndrome (ACS), and BARC type ≥3 bleeding), secondary thrombotic endpoint (cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis), bleeding endpoint (BARC type ≥2 bleeding) were analyzed during the extended follow-up period. Analysis was performed on the per-protocol population (2431 patients in the clopidogrel group and 2286 patients in the aspirin group). Results: During median follow-up of 5.8 years (interquartile range, 4.8 and 6.2 years), the primary endpoint occurred in 12.8% and 16.9% in the clopidogrel and aspirin groups, respectively (hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.63 to 0.86, p<0.001). The clopidogrel group had a lower risk for the secondary thrombotic endpoint (7.9% vs. 11.9%; HR 0.66, 95% CI 0.55 to 0.79, p<0.001) and secondary bleeding endpoint (4.5% vs. 6.1%; HR 0.74, 95% CI 0.57 to 0.94, p=0.016). There was no significant difference in the incidence of all-cause death between the two groups (6.2% vs. 6.0%; HR 1.04, 95% CI 0.82 to 1.31, p=0.742). Landmark analysis at 2 years showed that the beneficial effect of clopidogrel was consistent throughout the follow-up period. Conclusions: During an extended follow-up of over 5 years after randomization, clopidogrel monotherapy as compared with aspirin monotherapy was associated with lower rates of the composite net clinical outcome in patients without clinical events for 12±6 months after PCI with DES.

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Section: Trial Design and Oversightmentioning

confidence: 99%

Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The HOST-EXAM Extended Study

et al. 2023

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“…The primary endpoint was the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome (ACS) and major bleeding of Bleeding Academic Research Consortium (BARC) type ≥3, as previously defined in the HOST-EXAM trial. 12, 13 The status of all patients was cross-checked using the National Health Insurance Service System of South Korea and the South Korea National Statistics System. The definite cause of death was confirmed by the recorded data classified by the International Classification of Disease, 10th Revision, Clinical Modification codes.…”

Section: Clinical Outcomesmentioning

confidence: 99%

“…Details regarding the design of the HOST-EXAM trial have been described previously. 13 Briefly, the HOST-EXAM was an investigator-initiated, prospective, randomized, openlabel, multicentre trial conducted at 37 study sites in South Korea. All participants were randomly assigned in consecutive order to either the aspirin group (100 mg once daily) or clopidogrel group (75 mg once daily) in a ratio of 1 : 1.…”

Section: Study Design and Populationsmentioning

confidence: 99%

Body Mass Index and Major Adverse Events During Chronic Antiplatelet Monotherapy After Percutaneous Coronary Intervention With Drug-Eluting Stents　― Results From the HOST-EXAM Trial ―

Won

Shin

Kang

et al. 2023

Circ J

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Background: This study evaluated the association of body mass index (BMI) with adverse clinical outcomes during chronic maintenance antiplatelet monotherapy after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods and Results:Overall, 5,112 patients were stratified (in kg/m 2 ) into underweight (BMI ≤18.4), normal weight (18.5-22.9), overweight (23.0-24.9), obesity (25.0-29.9) and severe obesity (≥30.0) categories with randomized antiplatelet monotherapy of aspirin 100 mg or clopidogrel 75 mg once daily for 24 months. The primary endpoint was the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome and major bleeding of Bleeding Academic Research Consortium type ≥3. Compared with normal weight, the risk of primary composite outcomes was higher in the underweight (hazard ratio [HR] 2. 183 [1.199-3.974]), but lower in the obesity ) and severe obesity (HR 0.518 [0.278-0.966]) categories, which is partly driven by the difference in all-cause death. The risk of major bleeding was significantly higher in the underweight ) than in the normal weight category. A decrease in categorical BMI was independently associated with the increased risk of primary composite outcomes. Conclusions:Lower BMI is associated with a higher risk of primary composite outcomes, which is primarily related to the events of all-cause death or major bleeding during chronic maintenance antiplatelet monotherapy after PCI with DES.

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“…In particular, data on very long-term outcomes of P2Y12 blocker monotherapy are lacking. To the best of our knowledge, there is one pertinent trial that is currently being carried out in Korea in nearly 6000 PCI patients: the HOST-EXAM (NCT02044250) study [ 36 ]. In that trial, patients who have undergone PCI and have been treated with DAPT without events are randomised at the time of DAPT cessation (12–18 months post-PCI) to long-term clopidogrel monotherapy or long-term aspirin monotherapy (Fig.…”

Section: Future Perspectives On P2y12 Blocker Monotherapymentioning

confidence: 99%

“…3 Design of the currently running HOST-EXAM trial in Korea (NCT02044250). Reproduced from [ 36 ] with permission. ACS acute coronary syndrome, DAPT dual antiplatelet platelet therapy, DES drug-eluting stent, GI gastrointestinal, MI myocardial infarction, PCI percutaneous coronary intervention, TAPT triple antiplatelet therapy, TLR target lesion revascularisation, TVR target vessel revascularisation …”

Section: Future Perspectives On P2y12 Blocker Monotherapymentioning

confidence: 99%

P2Y12 blocker monotherapy after percutaneous coronary intervention

et al. 2021

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For secondary prevention of coronary artery disease (CAD) antiplatelet therapy is essential. For patients undergoing a percutaneous coronary intervention (PCI) temporary dual antiplatelet platelet therapy (DAPT: aspirin combined with a P2Y12 blocker) is mandatory, but leads to more bleeding than single antiplatelet therapy with aspirin. Therefore, to reduce bleeding after a PCI the duration of DAPT is usually kept as short as clinically acceptable; thereafter aspirin monotherapy is administered. Another option to reduce bleeding is to discontinue aspirin at the time of DAPT cessation and thereafter to administer P2Y12 blocker monotherapy. To date, five randomised trials have been published comparing DAPT with P2Y12 blocker monotherapy in 32,181 stented patients. Also two meta-analyses addressing this novel therapy have been presented. P2Y12 blocker monotherapy showed a 50–60% reduction in major bleeding when compared to DAPT without a significant increase in ischaemic outcomes, including stent thrombosis. This survey reviews the findings in the current literature concerning P2Y12 blocker monotherapy after PCI.

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Cited by 17 publications

References 50 publications

Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The HOST-EXAM Extended Study

Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The HOST-EXAM Extended Study

Body Mass Index and Major Adverse Events During Chronic Antiplatelet Monotherapy After Percutaneous Coronary Intervention With Drug-Eluting Stents　― Results From the HOST-EXAM Trial ―

P2Y12 blocker monotherapy after percutaneous coronary intervention

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Cited by 17 publications

References 50 publications

Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The HOST-EXAM Extended Study

Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The HOST-EXAM Extended Study

Body Mass Index and Major Adverse Events During Chronic Antiplatelet Monotherapy After Percutaneous Coronary Intervention With Drug-Eluting Stents ― Results From the HOST-EXAM Trial ―

P2Y12 blocker monotherapy after percutaneous coronary intervention

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Body Mass Index and Major Adverse Events During Chronic Antiplatelet Monotherapy After Percutaneous Coronary Intervention With Drug-Eluting Stents　― Results From the HOST-EXAM Trial ―