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Sex differences in coronary disease health Status outcomes: the ISCHEMIA trial
Anna Grodzinsky1, Yoon J Cho1, Phil G Jones1
1Saint Luke's Mid America Heart Institute, Saint Luke's Muriel I. Kauffman Institute for Women's Cardiovascular Research, University of Missouri-Kansas City, Kansas City, MO 64110, USA.
Insights
Women with coronary artery disease (CAD) experience worse angina than men. This study found that demographic factors, treatment intensity, and revascularization completeness did not explain these sex differences in angina. Further research into nociception and microvascular dysfunction is warranted.
Area of Science:
- Cardiology
- Clinical Research
- Health Services Research
Background:
- The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial observed that women reported worse angina symptoms than men, despite having less severe coronary artery disease (CAD) and ischemia.
- This disparity prompted an investigation into patient and treatment factors that could account for these sex-based differences in angina.
Purpose of the Study:
- To identify patient and treatment-related factors contributing to the observed sex differences in angina-related health status among patients with moderate to severe ischemia.
- To analyze the impact of demographic characteristics, clinical factors, and treatment strategies on sex-based disparities in angina.
Main Methods:
- The ISCHEMIA trial randomized patients with moderate or severe ischemia to an initial invasive or conservative strategy.
- Angina-related health status was assessed at baseline and 1-year using the Seattle Angina Questionnaire (SAQ).
- Statistical analyses were performed to compare SAQ scores between sexes and to evaluate the influence of various factors on these differences.
Main Results:
- Women reported significantly worse baseline angina-related health status (SAQ summary scores) than men, a difference not explained by demographics or clinical characteristics.
- At 1-year follow-up, women continued to have lower SAQ scores compared to men, irrespective of the treatment strategy (invasive vs. conservative).
- Adjusting for baseline scores, post-randomization treatment intensity (guideline-directed medical therapy), risk factor goal achievement, and revascularization completeness did not eliminate the sex-based differences in angina.
Conclusions:
- Women with chronic CAD in the ISCHEMIA trial consistently experienced worse angina-related health status than men.
- The observed sex differences in angina were not attributable to demographic factors, clinical characteristics, GDMT intensity, or revascularization completeness.
- Further investigation is needed into other potential mediating factors, such as differences in nociception, coronary microvascular dysfunction, and vasospasm, to fully understand these disparities.
Aims:
In the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial, women had worse angina than men despite less severe coronary artery disease (CAD) and ischaemia. We examined which patient and treatment factors might explain sex-based differences in angina.
Methods And Results:
ISCHEMIA randomized patients with moderate or severe ischaemia to an initial invasive strategy of cardiac catheterization with complete revascularization plus guideline-directed medical therapy (GDMT), or an initial conservative strategy of GDMT alone with invasive management reserved for GDMT failure. Coronary CT angiography was performed in most participants. Angina-related health status was collected at baseline and 1-year using the Seattle Angina Questionnaire (SAQ). Of 4617 ISCHEMIA participants with complete SAQ data, women averaged 6.5 points (95% CI 5.2 to 7.8) lower (worse) baseline SAQ-summary scores (SS) than men. This difference was not reduced by adjustment for demographics and clinical characteristics. Women had lower unadjusted 1-year SAQ-SS than men (Invasive -3.8 points, Conservative -5.7 points). These sex-based differences were attenuated but not eliminated by adjustment for baseline SAQ-SS. Adjustment for post-randomization treatment (GDMT intensity, risk factor goal achievement and, in the invasive strategy, complete revascularization) did not narrow the sex difference.
Conclusion:
Women with chronic CAD in ISCHEMIA had worse angina-related health status than men at baseline and 1-year. Differences were not explained by demographic or clinical characteristics, intensity of GDMT, or completeness of revascularization. It is thus important to consider other factors that may mediate these results, including differences in nociception, coronary microvascular dysfunction, and/or vasospasm.
Trial Registration:
ClinicalTrials.gov identifier: NCT01471522; https://clinicaltrials.gov/ct2/show/NCT01471522.
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