Evidence map›Paper›PMID 26152683›Full record

Trial reportCirculation. Cardiovascular quality and outcomes2015

Sex-Stratified Trends in Enrollment, Patient Characteristics, Treatment, and Outcomes Among Non-ST-Segment Elevation Acute Coronary Syndrome Patients: Insights From Clinical Trials Over 17 Years.

Kristian Kragholm, Sharif A Halim, Qinghong Yang, Phillip J Schulte, Judith S Hochman, Chiara Melloni, Kenneth W Mahaffey, David J Moliterno, Robert A Harrington, Harvey D White and 7 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation. Cardiovascular quality and outcomes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Gender disparities in coronary artery disease: a review of factors influencing clinical outcomes.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Kristian KragholmFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Sharif A HalimFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Qinghong YangFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Phillip J SchulteFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Judith S HochmanFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Chiara MelloniFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Kenneth W MahaffeyFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
David J MoliternoFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Robert A HarringtonFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Harvey D WhiteFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Paul W ArmstrongFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
E Magnus OhmanFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Frans Van de WerfFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Pierluigi TricociFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
John H AlexanderFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
Robert P GiuglianoFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.).
L Kristin NewbyFrom the Duke Clinical Research Institute, Durham, NC (K.K., S.A.H., Q.Y., P.J.S., C.M., E.M.O., P.T., J.H.A., L.K.N.); Cardiovascular Clinical Research Center, Leon H. Charney Division of Cardiology, New York University School of Medicine and NYU Langone Medical Center, New York, NY (J.S.H.); Department of Medicine, Stanford University, Stanford, CA (K.W.M., R.A.H.); Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY (D.J.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (F.V.d.W.); and Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G.). kristin.newby@duke.edu.

Funding

Postdoctoral Training in Cardiovascular Clinical ResearchT32HL069749 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2003 to 2023
$6.7M
NHLBI NIH HHS T32 HL069749
6 · The paper itself

Abstract

backgroundAdequate representation by sex in trials allows generalizability of results. We examined representation of women in clinical trials during a 17-year period in which inclusion criteria were broadened and federal mandates for representativeness were launched. METHODS AND

resultsUsing mixed models, we studied sex-stratified temporal trends in enrollment, clinical characteristics, treatment, and outcomes among 76 148 non-ST-segment elevation acute coronary syndrome patients using patient-level data merged from 11 phase III trials conducted from 1994 to 2010. Overall, 33.3% of patients were women, which changed minimally over time. Women were consistently 4 to 5 years older than men (median age 68 [interquartile range 61-75] versus 64 [interquartile range 56-72] years) and more frequently had diabetes mellitus, hypertension, and heart failure; men more frequently had prior myocardial infarction and revascularization. GRACE risk scores increased over time for both sexes with the inclusion of older patients with more comorbidities. Use of percutaneous coronary intervention, in-hospital and discharge angiotensin-converting enzyme inhibitor/angiotensin II receptor blockers, β-blockers, and lipid-lowering drugs also increased among both sexes. Kaplan-Meier estimates of 6-month mortality declined from 7.0% [95% confidence interval 6.5%-7.6%] to 4.5% [95% confidence interval 4.0%-5.0%] among women and 6.3% [95% confidence interval 6.0%-6.7%] to 3.1% [95% confidence interval 2.9%-3.4%] among men during the 17-year period.

conclusionsThe relative proportion of women in non-ST-segment elevation acute coronary syndrome trials changed minimally over time. Nevertheless, in parallel with men, use of evidence-based care and outcomes improved significantly over time among women.

Indexed as

ElectrocardiographyAcute Coronary SyndromeAdrenergic beta-AntagonistsAgedAged, 80 and overAngiotensin-Converting Enzyme InhibitorsCoronary AngiographyFemaleFollow-Up StudiesHumansHypolipidemic AgentsMaleMiddle AgedPercutaneous Coronary InterventionRegistriesRetrospective StudiesAdrenergic beta-AntagonistsAngiotensin-Converting Enzyme InhibitorsHypolipidemic Agentscoronary diseasemyocardial infarctionwomen

Identifiers

PMID26152683
PMCPMC4512844

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.