September 15, 2022Open Access
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 ―
Key Result
Being underweight was associated with a significantly higher risk of the primary composite outcome (HR 2.183) compared to normal weight during chronic antiplatelet monotherapy after percutaneous coronary intervention.
Study Design
Type
Cohort (n=5,112)
Blinding
Open-label
Randomization
1:1 (for the underlying trial)
Multicenter
Yes
Structured PICO
Does body mass index affect the risk of major adverse cardiovascular and bleeding events in patients on chronic antiplatelet monotherapy after PCI with DES?
P
Population
5,112 patients from South Korea who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and were event-free under dual antiplatelet therapy for ~1 year. Mean BMI 24.8 kg/m2.
I
Intervention
Underweight (BMI ≤18.4 kg/m2), overweight (23.0-24.9 kg/m2), obesity (25.0-29.9 kg/m2), and severe obesity (≥30.0 kg/m2) categories, receiving chronic antiplatelet monotherapy (aspirin 100 mg or clopidogrel 75 mg once daily).
C
Comparator
Normal weight category (BMI 18.5-22.9 kg/m2) receiving the same chronic antiplatelet monotherapy.
O
Outcome
Composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome and major bleeding of Bleeding Academic Research Consortium (BARC) type ≥3 at 24 months.composite
Lower BMI is associated with a higher risk of adverse clinical events and major bleeding during chronic antiplatelet monotherapy after PCI, while obesity is associated with a lower risk, supporting the obesity paradox.
Main Result
Effect estimate: HR 2.183 (95% CI 1.199-3.974)
Absolute Event Rate: 15.8% vs 7.7%
p-value: p=0.011
Limitations
- Open-label design has a potential bias in outcome reporting and ascertainment
- Information on variables comprising measures of fat distribution, physical activity level and serial BMI measures was unavailable
- The proportion of underweight participants was extremely low
- All study populations comprised East Asians, limiting generalization to other ethnicities
- Potential collider bias might influence the results
Abstract
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: ) 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 (HR 0.730 0.558-0.954) 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 (HR 4.140 1.704-10.059) 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.