Women and men with stable coronary artery disease have similar clinical outcomes: insights from the international prospective CLARIFY registry
Key result
Female sex is linked to similar 1-year major cardiovascular event rates compared to male sex.
- OR 0.93
- 95% CI 0.75-1.15
- P=0.50
- n=30,977
Figures
Why the study?
Men and women differ in coronary artery disease presentation and management, but whether these differences translate into different clinical outcomes in stable CAD is unclear.
Does female sex affect the composite of cardiovascular death, non-fatal myocardial infarction, or stroke in outpatients with stable coronary artery disease?
Key Points
- To compare 1-year cardiovascular clinical outcomes between men and women with stable coronary artery disease.
- Analyzed 1-year outcomes in 30,977 outpatients (23,975 men and 7,002 women) with stable coronary artery disease enrolled in the international prospective CLARIFY registry.
- Evaluated differences in baseline cardiovascular risk factors, diagnostic procedures (non-invasive testing and coronary angiography), and prescribed evidence-based medical therapies.
- Adjusted 1-year rates of the primary composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke were 1.7% in men versus 1.8% in women (OR 0.93, 95% CI 0.75-1.15, P = 0.50).
- Adjusted secondary outcomes did not differ significantly, including all-cause death (1.5% in men vs. 1.6% in women, OR 0.91, 95% CI 0.72-1.13, P = 0.39) and fatal or non-fatal myocardial infarction (1.0% vs. 0.9%, OR 0.81, 95% CI 0.60-1.08, P = 0.15).
- Significantly fewer women underwent myocardial revascularization during follow-up compared with men (2.2% vs. 2.6%, OR 0.77, 95% CI 0.64-0.93, P = 0.007).
Study Design
Type
Observational (n=30,977)
Multicenter
Yes
Structured PICO
Does female sex affect the composite of cardiovascular death, non-fatal myocardial infarction, or stroke in outpatients with stable coronary artery disease?
P
Population
30,977 outpatients with stable coronary artery disease from 45 countries, followed for 1 year to compare cardiovascular outcomes between men and women.
E
Exposure
Female sex
C
Comparator
Male sex
O
Outcome
Composite of cardiovascular death, non-fatal myocardial infarction, or stroke at 1 yearcomposite
Main Result
Odds Ratio: 0.93 (95% CI 0.75–1.15)
Absolute Event Rate: 1.8% vs 1.7%
p-value: p=0.50
Despite differences in baseline characteristics and management, women and men with stable coronary artery disease have similar 1-year cardiovascular outcomes.
Limitations
- Observational nature prevents causality inference
- No patients enrolled from the USA
- Voluntary participation may not be representative of a population-based sample
- Selection criteria may have skewed enrolment of women towards lower risk
- Not a non-inferiority study
- Loss to follow-up and incomplete data
Ask about this paper
Answers are grounded in this paper and cite their sources.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“For the first time, we can see that many patients with CAD have too high resting heart rate levels, and combined internal evidence from CLARIFY and external evidence from prior sources indicate that this is associated with worse symptoms and worse clinical outcomes. These findings suggest tighter control of baseline heart rate with heart-rate-lowering medications may benefit CAD patients by improving symptom control and outcomes.”
Implication
Supports equivalent prognosis by sex in stable CAD outpatients; leaves open whether revascularization gaps reflect bias or appropriate care.
Abstract
AIMS: Men and women differ in terms of presentation and management in coronary artery disease (CAD). Whether these differences translate into different clinical outcomes in stable CAD is unclear. We analysed data from the international prospective CLARIFY registry to compare cardiovascular clinical outcomes in men and women with stable CAD. METHODS AND RESULTS: We analysed 1-year outcomes in 30 977 outpatients with stable CAD [23 975 (77.4%) men; 7002 (22.6%) women]. Women were older than men, more likely to have hypertension and diabetes, and less likely to exercise or smoke. They had more frequent angina, but were less likely to have undergone diagnostic non-invasive testing or coronary angiography. Women received less optimized treatment for stable CAD. One-year outcomes were similar for men and women for the composite of cardiovascular death, non-fatal myocardial infarction, or stroke [adjusted rates 1.7 vs. 1.8%, respectively, odds ratio (OR) 0.93, 95% confidence interval (CI) 0.75-1.15]; all-cause death (adjusted 1.5 vs. 1.6%, OR: 0.91, 95% CI: 0.72-1.13); fatal or non-fatal myocardial infarction (adjusted 1.0 vs. 0.9%, OR: 0.81, 95 CI: 0.60-1.08); and cardiovascular death or non-fatal myocardial infarction (adjusted 1.4 vs. 1.4%, OR: 0.89, 95% CI: 0.70-1.12). Fewer women underwent revascularization (2.6 vs. 2.2%, OR: 0.77, 95% CI: 0.64-0.93), although appropriateness was not analysed. CONCLUSION: The risk profiles of women and men with stable CAD differ substantially. However, 1-year outcomes were similar. Fewer women underwent revascularization. Further research is needed to better understand gender determinants of outcome and devise strategies to minimize bias in the management and treatment of women.
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Cite This Study
Steg et al. (2012) conducted an observational in Stable coronary artery disease (n=30,977). Female sex vs. Male sex was evaluated on Composite of cardiovascular death, non-fatal myocardial infarction, or stroke (OR 0.93, 95% CI 0.75-1.15, p=0.50). In outpatients with stable coronary artery disease, female sex was associated with similar 1-year rates of cardiovascular death, non-fatal myocardial infarction, or stroke compared to male sex.