Trends in Non–ST-Segment Elevation Acute Coronary Syndrome by Sex

Study Questions:

Are trends in the management of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) different for women and men?

Methods:

Data from clinical trials over a 17-year period were included in this analysis. All phase III clinical trials of antithrombotic therapy in patients presenting with NSTE-ACS were included, either NSTE myocardial infarction (NSTEMI) or unstable angina in which the Duke Clinical Research Institute had a coordinating center role (n = 8), along with three trials conducted elsewhere for which patient-level data were available. Baseline characteristics in-hospital and discharge medications, use of coronary angiography, and revascularization procedures were collected, in addition to 30-day and 6-month mortality. Time periods were examined by four prespecified periods (1994–1997, 1998–2001, 2002–2005, and 2006–2010). Data on glycoprotein IIb/IIIa inhibitors and heparins were not included in the models, as these treatments were part of the protocols for the trials included. Data were stratified by sex and examined for trends over time. The primary outcomes of interest included 30-day and 6-month mortality.

Results:

A total of 76,148 patients (46,196 presenting with NSTEMI and 28,890 presenting with unstable angina) were included from 11 phase III trials (conducted from 1994–2010). In this cohort, women represented 33.3% of the participants. Women were older by approximately 4-5 years compared to men, and were more likely to have diabetes mellitus, hypertension, and heart failure. Men were more likely to have a prior history of MI and revascularization compared to women. Women had higher median 6-month GRACE risk scores and had GRACE scores ≥140 more often than men. Compared with men, women less frequently had prior MI, percutaneous coronary intervention (PCI), and bypass surgery. Women also had higher rates of bleeding and transfusion rates compared to men. Over the time period examined, the GRACE risk scores increased for both men and women as more patients who were older and had more comorbidities were included in trials. Over time, use of PCI and cardiac medications (angiotensin-converting enzyme inhibitor/angiotensin II receptor blockers, beta-blockers, and lipid-lowering drugs) increased for both men and women. Over the 17-year time period examined, 6-month mortality declined from 7.0% (95% confidence interval [CI], 6.5%-7.6%) to 4.5% (95% CI, 4.0%-5.0%) among women. A similar trend was observed in men (6.3% [95% CI, 6.0%-6.7%] to 3.1% [95% CI, 2.9%-3.4%]).

Conclusions:

The authors concluded that the relative proportion of women included in NSTE-ACS trials has not changed significantly over the time period included. However, use of evidence-based treatment and associated outcomes has improved for women as well as men over time.

Perspective:

Two central messages are apparent from this analysis. One, there is a continued need to make sure women are adequately represented in clinical trials. Two, increased use of evidence-based management has improved ACS outcomes for both women and men.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Dyslipidemia, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Anticoagulation Management and ACS, Lipid Metabolism, Acute Heart Failure, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging, Hypertension

Keywords: Acute Coronary Syndrome, Adrenergic beta-Antagonists, Angina, Unstable, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Coronary Angiography, Diabetes Mellitus, Fibrinolytic Agents, Heart Failure, Heparin, Hypertension, Lipids, Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex, Secondary Prevention, Women


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