Coronary Artery Calcification (CAC) and Post‐Trial Cardiovascular Events and Mortality Within the Women's Health Initiative (WHI) Estrogen‐Alone Trial

Background Among women aged 50 to 59 years at baseline in the Women's Health Initiative (WHI) Estrogen‐Alone (E‐Alone) trial, randomization to conjugated equine estrogen‐alone versus placebo was associated with lower risk of myocardial infarction and mortality, and, in an ancillary study, the W...

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Published in:	Journal of the American Heart Association Vol. 6; no. 11
Main Authors:	Poornima, Indu G., Mackey, Rachel H., Manson, JoAnn E., LaMonte, Michael J., Chang, Yuefang, Kuller, Lewis H., Rossouw, J.E., Ludlam, S., Cochrane, B.B., Hunt, J.R., Lund, B., Prentice, R., O'Rourke, C., Du, L., Pillsbury, S., Hightower, C., Ellison, R., Tan, J., Wassertheil‐Smoller, S., Noble, D.H., Bueche, M., McGinnis, A.D., Rybicki, F.J., Assaf, A.R., Sloane, G., Phillips, L.S., Butler, V., Vitali, J., Hsia, J., LeBrun, C., Palm, R., Embersit, D., Whitlock, E., Arnold, K., Cantrell, V., Feltz, C., Thomas‐Geevarghese, A., Boggs, G., Jelinick, J.S., Greenland, P., Neuman, A., Carlson‐Lund, G., Giovanazzi, S.M., Jackson, R., Toussant, K., Lewis, C.E., Wactawski‐Wende, J., Laughlin, R., Robbins, J., Zaragoza, S., Belisle, D., Nathan, L., Voigt, B., Goldin, J., Woo, M., Lien, X., Wright, C.M., Sheridan, S., Feddersen, D., Kelly‐Brake, K., Carroll, J., Ockene, J., Churchill, L., Miller, B., Fishman, J., Fernandez, D., Margolis, K.L., Bjerk, C.L., Truwit, C., Hearity, J.A., Hyslop, W.B., Darroch, K., Murphy, C., Heiss, G., Edmundowicz, D., Ives, D., Johnson, K.C., Satterfield, S., Connelly, S.A., Jones, E.L., Brzyski, R., Nashawati, M.A., Torchia, S., Rodriguez, A., Nentwich, P., Sarto, G.E., Broderick, L., Sweitzer, N.K., Rossouw, Jacques, Ludlam, Shari, McGowan, Joan, Geller, Nancy, Anderson, Garnet, Prentice, Ross, Jackson, Rebecca, Wactawski‐Wende, Jean, Limacher, Marian, Robinson, Jennifer, Shumaker, Sally
Format:	Journal Article
Language:	English
Published:	England John Wiley and Sons Inc 01-11-2017 Wiley
Subjects:	cardiovascular disease Chi-Square Distribution Computed Tomography Angiography Coronary Angiography - methods coronary artery calcification Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - epidemiology Coronary Artery Disease - mortality Estrogen Replacement Therapy - adverse effects Estrogen Replacement Therapy - methods Estrogen Replacement Therapy - mortality Estrogens, Conjugated (USP) - administration & dosage Estrogens, Conjugated (USP) - adverse effects Female hormonal therapy Humans Incidence Middle Aged mortality Multivariate Analysis Original Research Postmenopause Proportional Hazards Models Risk Factors Time Factors Treatment Outcome United States - epidemiology Vascular Calcification - diagnostic imaging Vascular Calcification - epidemiology Vascular Calcification - mortality women Women's Health hormonal therapy mortality cardiovascular disease coronary artery calcification women
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Summary:	Background Among women aged 50 to 59 years at baseline in the Women's Health Initiative (WHI) Estrogen‐Alone (E‐Alone) trial, randomization to conjugated equine estrogen‐alone versus placebo was associated with lower risk of myocardial infarction and mortality, and, in an ancillary study, the WHI‐CACS (WHI Coronary Artery Calcification Study) with lower CAC, measured by cardiac computed tomography ≈8.7 years after baseline randomization. We hypothesized that higher CAC would be related to post‐trial coronary heart disease (CHD), cardiovascular disease (CVD), and total mortality, independent of baseline randomization or risk factors. Methods and Results WHI‐CACS participants (n=1020) were followed ≈8 years from computed tomography scan in 2005 (mean age=64.4) through 2013 for incident CHD (myocardial infarction and fatal CHD, n=17), CVD (n=69), and total mortality (n=55). Incident CHD and CVD analyses excluded women with CVD before scan (n=89). Women with CAC=0 (n=54%) had very low age‐adjusted rates/1000 person‐years of CHD (0.91), CVD (5.56), and mortality (3.45). In comparison, rates were ≈2‐fold higher for women with any CAC (>0). Associations were not modified by baseline randomization to conjugated equine estrogen–alone versus placebo. Adjusted for baseline randomization and risk factors, the hazard ratio (95% confidence interval) for CAC >100 (19%) was 4.06 (2.11, 7.80) for CVD and 2.70 (1.26, 5.79) for mortality. Conclusions Among a subset of postmenopausal women aged 50 to 59 years at baseline in the WHI E‐Alone Trial, CAC at mean age of 64 years was strongly related to incident CHD, CVD, and to total mortality over ≈8 years, independent of baseline randomization to conjugated equine estrogen–alone versus placebo or CVD risk factors. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00000611.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 Dr Poornima and Dr Mackey contributed equally to this work. A complete list of the WHI and WHI‐CAC Study Investigators can be found in the Appendix at the end of the manuscript.
ISSN:	2047-9980 2047-9980
DOI:	10.1161/JAHA.117.006887