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High-STEACS: Troponin test could improve accuracy of MI diagnosis in women
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AMSTERDAM — Preliminary results from a study presented at ESC Congress 2013 suggest that a high-sensitivity troponin test may help improve the diagnosis and prognosis of patients presenting with MI symptoms. The test could be particularly helpful for women, who may have different presenting symptoms and are often underdiagnosed.
Nicholas Mills, MBChB,presented data on the first 1,126 patients (55% men) in the High-STEACS study who presented with suspected ACS. The study goal was to determine whether a high-sensitivity troponin test (Architect STATHigh Sensitive Troponin-I test, Abbott) can improve the diagnosis and prognosis of these patients.
“Inequalities exist in the treatment and outcome of men and women with ACS, with an increase in both early and late deaths in women. High-sensitivity troponin assays have identified differences in the reference range between men and women with 99th percentiles twofold higher in men,” Mills, a cardiologist at University of Edinburgh, Scotland, said at a presentation. “Whether use of a single diagnostic threshold has contributed to the underdiagnosis of MI in women is unknown. This study evaluated the impact of sex-specific diagnostic thresholds for MI in consecutive men and women with suspected ACS,” he said.
Disparities in diagnosis
Using contemporary assays, approximately one in four men were diagnosed with type 1 MI vs. one in eight women. However, when using the high-sensitivity troponin test with sex-specific thresholds, men were diagnosed at about the same rate as with the contemporary assays, but women were diagnosed at about the same rate as the men, Mills said.
The contemporary assay used a troponin-I threshold of 50 ng/L. The high-sensitivity assay used a threshold of 26 ng/L. The high-sensitivity assay with sex-specific thresholds used a threshold of 34 ng/L for men and 16 ng/L for women.
The contemporary assay had a sensitivity of 77% for men and 47% for women. The high-sensitivity assay with a single threshold had a sensitivity of 87% for men and 68% for women. The high-sensitivity assay with sex-specific thresholds had a sensitivity of 86% for men and 95% for women.
Patients were treated based only on the results of the contemporary assay, Mills said. The researchers also evaluated treatment outcomes for men and women based on troponin-I concentrations. Of particular interest are women with troponin-I concentrations between 17 ng/L and 49 ng/L, because they were not diagnosed with or treated for MI based on the contemporary assay, but they met the definition of MI based on results from the high-sensitivity assay with sex-specific thresholds, he said.
At 6 months, about one in four women with troponin-I concentrations between 17 ng/L and 49 ng/L had a recurrent MI or died compared with less than 2% of women with troponin-I concentrations ≤16 ng/L (P<.001).
“These outcomes were similar to or worse than patients with much larger infarcts who were treated based on the contemporary assay,” he said.
Sex-specific thresholds recommended
“Use of contemporary troponin assays and single diagnostic thresholds contributes to the underdiagnosis of MI, particularly in women, and to sex inequalities in intervention and treatment,” Mills said. “We therefore recommend the use of sex-specific diagnostic thresholds and will address in the ongoing trial whether implementation of the high specific assay will improve outcomes and address inequalities in the treatment of patients with suspected ACS.”
The High-STEACS study is scheduled to enroll more than 25,000 patients in Scotland and to be completed in 2016.
The test received CE Mark in January. In the United States it is approved for research only.
For more information:
Mills N. Clinical Trial Update Hot Line III: Updates on risk and outcome. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.
Disclosure: The study is funded by a grant from the British Heart Foundation; Abbott provided the assay. Mills reports financial ties with Abbott Diagnostics, Beckman & Coulter, GlaxoSmithKline and Sanofi-Aventis.