Key result
Clopidogrel cuts major events ~30% versus aspirin in men, with mitigated benefit in women.
Why the study?
It remained unknown whether the clinical benefits of clopidogrel monotherapy versus aspirin monotherapy after PCI with DES differ based on sex.
Does clopidogrel monotherapy improve clinical outcomes compared to aspirin monotherapy in men versus women after PCI with DES?
RCT
Randomized
Does clopidogrel monotherapy improve clinical outcomes compared to aspirin monotherapy in men versus women after PCI with DES?
Hazard Ratio: 0.7 (95% CI 0.55–0.89)
p-value: p=0.004
Clopidogrel monotherapy after PCI with DES provides significant ischemic and bleeding benefits over aspirin in men, but these benefits appear attenuated in women.
Clopidogrel benefit seen in men but mitigated in women; leaves open confirmation before sex-specific monotherapy guidance.
Background Clopidogrel monotherapy was more effective in reducing the risk of adverse clinical events than aspirin monotherapy in patients who underwent percutaneous coronary intervention (PCI) with drug‐eluting stent (DES), according to the HOST‐EXAM (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis–Extended Antiplatelet Monotherapy) trial. However, it remains unknown whether these effects differ based on sex. Methods and Results This was a prespecified secondary analysis of HOST‐EXAM in South Korea. Patients who maintained dual antiplatelet therapy without adverse clinical events for 6 to 18 months after PCI with DES were included. The primary end point was a composite of all‐cause mortality, nonfatal myocardial infarction, stroke, acute coronary syndrome, or Bleeding Academic Research Consortium (BARC) bleeding type ≥3 at 24 months after randomization. The bleeding end point was BARC types 2 to 5. The primary end point was comparable between the sexes (adjusted hazard ratio [HR], 0.79 [95% CI, 0.62–1.02]; P =0.067), and the bleeding end point (adjusted HR, 0.79 [95% CI, 0.54–1.17]; P =0.240) was also similar. Compared with aspirin, clopidogrel was associated with lower risk of primary composite end point (adjusted HR, 0.70 [95% CI, 0.55–0.89]; P =0.004) and bleeding end point (adjusted HR, 0.65 [95% CI, 0.44–0.96]; P =0.031) in men but not in women. Conclusions The primary composite end point and bleeding events were comparable between the sexes during chronic maintenance antiplatelet monotherapy after PCI with DES. Clopidogrel monotherapy, compared with aspirin, significantly reduced the risk of the primary composite end point and bleeding events in men. However, the beneficial effect of clopidogrel on the primary end point and bleeding events was mitigated in women. Registration Information clinicaltrials.gov . Identifier: NCT02044250.
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Shin et al. (2023) conducted an RCT in Percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Clopidogrel monotherapy vs. Aspirin monotherapy was evaluated on Composite of all-cause mortality, nonfatal myocardial infarction, stroke, acute coronary syndrome, or Bleeding Academic Research Consortium (BARC) bleeding type ≥3 (HR 0.70, 95% CI 0.55-0.89, p=0.004). Clopidogrel monotherapy, compared with aspirin, significantly reduced the risk of the primary composite end point in men (HR 0.70; 95% CI 0.55-0.89; P=0.004), but this benefit was mitigated in women.
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