Aspirin vs. Clopidogrel as a Chronic maintenance monotherapy after PCI in patients with high ischemic risk and high bleeding risk: Subgroup analysis of the HOST-EXAM trial

Funding Acknowledgements Type of funding sources: None. OnBehalf on behalf of the HOST-EXAM investigators Background The HOST-EXAM randomized clinical trial recently performed a comparison of clopidogrel monotherapy vs. aspirin monotherapy in patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention (PCI). This study randomized 5,438 patients who maintained dual antiplatelet therapy without clinical events for 6–18 months after PCI with drug-eluting stents (DES) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. During the 24-month follow-up, the primary outcome (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) rate was significantly lower in the clopidogrel group (hazard ratio [HR] 0.73 [95% CI 0.59–0.90]; p = 0.0035). However, it is uncertain whether the beneficial effect of clopidogrel will be consistent in patients with high ischemic risk or those with high bleeding risk. Methods This is a post-hoc analysis of the HOST-EXAM trial. A high ischemic risk was defined as those who had at least 1 of the following procedural features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length >60 mm, or left main PCI. Patients with high bleeding risk were defined according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. The co-primary outcome were thrombotic endpoints (a composite of cardiac death, non-fatal myocardial infarction, ischemic stroke, readmission due to acute coronary syndrome, and definite or probable stent thrombosis) and bleeding endpoints (BARC type ≥2 bleeding events) at 24-month follow-up. Results Among the total population, 22.1% had high ischemic risk and 21.4% had high bleeding risk. Complex PCI was not associated with a higher risk of thrombotic endpoints, nor bleeding endpoints. For patients with a high bleeding risk, these patients had a higher risk of both thrombotic endpoints (HR 1.545, 95% CI 0.141-2.092, p = 0.005) and bleeding endpoints (HR 3.418, 95% CI 2.413-4.840, p < 0.001). The primary results focusing on the interaction between high ischemic risk, high bleeding and the antiplatelet regimen will be presented. Conclusion The current post-hoc analysis of the HOST-EXAM trial will evaluate the efficacy of clopidogrel monotherapy vs. aspirin monotherapy during the chronic maintenance period after PCI, in patients with high ischemic risk or those with high bleeding risk.