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Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The
Jeehoon Kang1, Kyung Woo Park1, Huijin Lee1
1Seoul National University Hospital, Korea (J.K., K.W.P., H.L., D.H., H.-M.Y., J.-K.H., B.-K.K., H.-S.K.).
Insights
Long-term clopidogrel monotherapy after drug-eluting stent percutaneous coronary intervention significantly reduced major adverse events compared to aspirin. This extended follow-up confirms clopidogrel
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Long-term outcomes of antiplatelet monotherapy post-percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remain incompletely understood.
- The HOST-EXAM Extended study provides crucial post-trial follow-up data on antiplatelet monotherapy strategies.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of clopidogrel monotherapy versus aspirin monotherapy in patients after PCI with DES.
- To compare composite net clinical outcomes, thrombotic events, and bleeding events between clopidogrel and aspirin monotherapy groups.
Main Methods:
- 5438 patients with DES-PCI, event-free on dual antiplatelet therapy for 12±6 months, were randomized to clopidogrel or aspirin monotherapy.
- Primary endpoint: composite of death, myocardial infarction, stroke, ACS readmission, and BARC ≥3 bleeding.
- Secondary endpoints: thrombotic and bleeding events analyzed over an extended follow-up period.
Main Results:
- Clopidogrel monotherapy showed a significantly lower rate of the primary composite endpoint (12.8% vs. 16.9%; HR 0.74, P<0.001) over median 5.8 years.
- Reduced risks observed for secondary thrombotic (HR 0.66, P<0.001) and bleeding endpoints (HR 0.74, P=0.016) with clopidogrel.
- No significant difference in all-cause mortality between groups (P=0.742); clopidogrel's benefit was consistent long-term.
Conclusions:
- Clopidogrel monotherapy is associated with superior long-term net clinical outcomes compared to aspirin monotherapy in select PCI patients.
- The findings support clopidogrel monotherapy as a potentially more effective strategy for reducing ischemic events while managing bleeding risk post-PCI.
Background:
Long-term outcomes of antiplatelet monotherapy in patients who receive percutaneous coronary intervention are unknown. The HOST-EXAM (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Extended Antiplatelet Monotherapy) Extended study reports the posttrial 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 percutaneous coronary intervention with drug-eluting stents were randomly assigned in a 1:1 ratio to receive clopidogrel (75 mg once daily) or aspirin (100 mg once daily). The primary end point (a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission attributable to acute coronary syndrome, and Bleeding Academic Research Consortium type 3 or greater bleeding), secondary thrombotic end point (cardiac death, nonfatal myocardial infarction, ischemic stroke, readmission attributable to acute coronary syndrome, and definite or probable stent thrombosis), and bleeding end point (Bleeding Academic Research Consortium type 2 or greater 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 a median follow-up of 5.8 years (interquartile range, 4.8-6.2 years), the primary end point occurred in 12.8% and 16.9% in the clopidogrel and aspirin groups, respectively (hazard ratio, 0.74 [95% CI, 0.63-0.86]; P<0.001). The clopidogrel group had a lower risk for the secondary thrombotic end point (7.9% versus 11.9%; hazard ratio, 0.66 [95% CI, 0.55-0.79]; P<0.001) and secondary bleeding end point (4.5% versus 6.1%; hazard ratio, 0.74 [95% CI, 0.57-0.94]; P=0.016). There was no significant difference in the incidence of all-cause death between the 2 groups (6.2% versus 6.0%; hazard ratio, 1.04 [95% CI, 0.82-1.31]; 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 >5 years after randomization, clopidogrel monotherapy 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 percutaneous coronary intervention with drug-eluting stents.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT02044250.
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