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女性健康倡议(WHI)单独使用雌激素试验中的冠状动脉钙化(CAC)和试验后心血管事件和死亡率。

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

机构信息

Division of Cardiology, Allegheny General Hospital, Pittsburgh, PA.

Temple University School of Medicine, Philadelphia, PA.

出版信息

J Am Heart Assoc. 2017 Oct 27;6(11):e006887. doi: 10.1161/JAHA.117.006887.

DOI:10.1161/JAHA.117.006887
PMID:29079563
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5721773/
Abstract

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.

摘要

背景

在妇女健康倡议(WHI)雌激素单独治疗(E-Alone)试验中,基线时年龄在 50 至 59 岁的女性中,随机分配接受共轭马雌激素单独治疗与安慰剂相比,心肌梗死和死亡率风险降低,并且在一项辅助研究中,WHI-CACS(WHI 冠状动脉钙化研究)与通过心脏计算机断层扫描测量的 CAC 降低有关≈基线随机分组后 8.7 年。我们假设较高的 CAC 与试验后冠心病(CHD)、心血管疾病(CVD)和总死亡率相关,独立于基线随机分组或危险因素。

方法和结果

WHI-CACS 参与者(n=1020)从 2005 年的计算机断层扫描(平均年龄 64.4 岁)开始随访,直到 2013 年,共发生 CHD(心肌梗死和致命性 CHD,n=17)、CVD(n=69)和总死亡率(n=55)。CHD 和 CVD 分析排除了扫描前患有 CVD 的女性(n=89)。CAC=0(n=54%)的女性 CHD(0.91/1000 人年)、CVD(5.56/1000 人年)和死亡率(3.45/1000 人年)的年龄调整率非常低。相比之下,任何 CAC(>0)的女性的比率约为两倍。这些关联不受基线随机分组为共轭马雌激素单独治疗与安慰剂的影响。在校正基线随机分组和危险因素后,CAC>100(19%)的危险比(95%置信区间)为 CVD 的 4.06(2.11,7.80)和死亡率的 2.70(1.26,5.79)。

结论

在 WHI E-Alone 试验中,基线时年龄在 50 至 59 岁的绝经后女性亚组中,64 岁时 CAC 与 CHD、CVD 和总死亡率的发生高度相关,随访时间约为 8 年,与基线时随机分组为共轭马雌激素单独治疗与安慰剂或 CVD 危险因素无关。

临床试验注册

网址:https://www.clinicaltrials.gov。独特标识符:NCT00000611。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66f6/5721773/08e70e4e6a93/JAH3-6-e006887-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66f6/5721773/80e1f0c2190e/JAH3-6-e006887-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66f6/5721773/8aaa0b394f45/JAH3-6-e006887-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66f6/5721773/08e70e4e6a93/JAH3-6-e006887-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66f6/5721773/80e1f0c2190e/JAH3-6-e006887-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66f6/5721773/8aaa0b394f45/JAH3-6-e006887-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66f6/5721773/08e70e4e6a93/JAH3-6-e006887-g003.jpg

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