CV event risk lower in women vs. men after non-ST segment elevation ACS
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Women who were enrolled in clinical trials had a lower risk for major adverse CV events compared with men after non-ST segment elevation ACS, according to a sex-specific analysis published in the Journal of the American College of Cardiology.
Researchers also found that women were undertreated compared with men.
“We should be conscious of the fact that accumulating risk factors for coronary disease (including high BP, diabetes and kidney disease) not only increase a woman’s risk of having a cardiac event, but also increases her changes of having poorer outcomes after such an event,” Amy A. Sarma, MD, noninvasive cardiologist at Massachusetts General Hospital, told Healio. “In addition, it highlights that we as a medical community are still underutilizing guideline-directed medical therapies in women, and we should be collectively more conscious of this.”
TIMI Study Group trials
Researchers analyzed data from 10 trials conducted by the TIMI Study Group. Each trial had assigned treatment to at least 2,500 patients with non-ST segment elevation ACS within 30 days of hospitalization. The total number of patients included in this analysis was 68,730, of whom 29% were women.
The primary outcome was major adverse CV events, which was defined as a composite of MI, CV death or stroke. All-cause mortality and individual components of the composite outcome were also assessed.
Compared with men, women were more likely to be older (67 years vs. 62 years) and have a higher prevalence of comorbidities including diabetes (34.6% vs. 27.4%), hypertension (76.8% vs. 64.4%), baseline renal impairment (26.3% vs. 16.9%) and prior HF (12.9% vs. 9.2%; P < .001 for all).
Women had a similar risk for major adverse CV events compared with men before relevant confounders were considered (HR = 1.04; 95% CI, 0.99-1.09). Despite this, they had a higher risk for all-cause mortality vs. men (HR = 1.12; 95% CI, 1.01-1.24).
After adjusting for baseline differences, women had a lower risk for major adverse CV events (HR = 0.93; 95% CI, 0.88-0.98) and all-cause death (HR = 0.84; 95% CI, 0.78-0.9) compared with men.
Women were less likely to undergo coronary angiography (69.7% vs. 76.2%; P < .001) or PCI (49.2% vs. 59%; P < .001) compared with men for the management of non-ST segment elevation ACS. This trend persisted after patients with unstable angina were excluded.
Women who underwent coronary angiography were more likely to have nonobstructive CAD compared with men (10.9% vs. 4.4%; P < .0001) and were less likely to require PCI (70.4% vs. 77.1%; P < .0001).
When high-risk patients were assessed, women were less likely to be treated with a P2Y12 inhibitor, aspirin or statin therapy or to undergo coronary angiography or PCI compared with men.
“Given that we know that baseline comorbidities are key to the higher risk of adverse events (and mortality) in women as compared with men after an ACS, whether efforts to improve primary prevention of the development of these risk factors results in a significant improvement in the CV health, particularly of women, is an area that warrants further research, but also should guide improvements in clinical practice,” Sarma said in an interview. “Further, we consistently observed that women are underrepresented in CV studies. Ensuring that the therapies that we investigate are equally efficacious in men and women requires greater enrollment of women in current clinical trials. As such, further study is required to understand the basis for the under-enrollment of women in such studies.”
Further research
Michael E. Farkouh, MD, MSc, professor and vice chair of research in the department of medicine at the University of Toronto, the Peter Munk Chair in Multinational Clinical Trials at the Peter Munk Cardiac Centre at Toronto General Hospital and director of the Heart and Stroke/Richard Lewar Centre of Excellence in Cardiovascular Research in Toronto, and Wendy Tsang, MD, SM, professor in the division of cardiology at the University of Toronto, wrote a related editorial, in which they wrote: “More studies are needed on the overall population of women with non-ST segment elevation ACS to improve disease prevention, diagnosis and response to therapy. We desperately need strategies to enhance the enrollment of women in these randomized trials, and this should be a high priority for funding agencies and industry sponsors. Ultimately, sex- and age-specific strategies for the diagnosis of ACS in women should be developed to improve women’s health outcomes.” – by Darlene Dobkowski
For more information:
Amy A. Sarma, MD, can be reached at asarma1@partners.org.
Disclosures: Sarma reports no relevant financial disclosures. Farkouh reports he received research support from Amgen and Novo Nordisk. Tsang reports she is supported by a National New Investigator Award from the Heart and Stroke Foundation of Canada. Please see the study for all other authors’ relevant financial disclosures.