The results from the ELITE (Early versus Late Intervention Trial with Estradiol) study have been long awaited because of its desired methodology. This was a single-center, randomized, double-blind, placebo-controlled trial in which serial carotid arterial measurements were obtained non-invasively . Participants were 643 healthy postmenopausal women without diabetes and without clinical evidence of cardiovascular disease who had had no regular menses for at least 6 months or who had surgically induced menopause. At the time of randomization, participants were stratified according to the number of years past menopause: less than 6 years or 10 or more years. Participants were randomly assigned to receive oral 17β-estradiol (1 mg daily) or matching placebo. Women in the estradiol group who had a uterus also received micronized progesterone (45 mg) as a 4% vaginal gel (for 10 days per month), whereas women in the placebo group who had a uterus received matching placebo gel. The intima-media thickness at the right distal common carotid artery (CIMT) was measured every 6 months during a median 5-year follow-up period. As a secondary endpoint, cardiac CT was performed when participants completed the randomly assigned regimen. Among women who were less than 6 years past menopause at the time of randomization, the mean CIMT increased by 0.0078 mm per year in the placebo group versus 0.0044 mm per year in the estradiol group (p = 0.008). Among women who were 10 or more years past menopause at the time of randomization, the rates of CIMT progression in the placebo and estradiol groups were similar (0.0088 and 0.0100 mm per year, respectively; p = 0.29). CT values of coronary-artery calcium, total stenosis, and plaque did not differ significantly between the placebo group and the estradiol group in either postmenopause stratum.
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Hodis HN, Mack WJ, Henderson VW, et al. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med 2016;374:1221-31
Harman SM, Black DM, Naftolin F, et al. Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: a randomized trial. Ann Intern Med 2014;161:249-60
Allison MA, Manson JE, Langer RD, et al. Oophorectomy, hormone therapy, and subclinical coronary artery disease in women with hysterectomy: the Women’s Health Initiative coronary artery calcium study. Menopause 2008;15:639-47