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Heart and Estrogen/Progestin Replacement Study Follow-up (HERS II)

Deborah Grady, MD, MPH; David Herrington, MD, MHS; Vera Bittner, MD; Roger Blumenthal, MD; Michael Davidson, MD; Mark Hlatky, MD; Judith Hsia, MD; Stephen Hulley, MD, MPH; Alan Herd, MD; Steven Khan, MD; L. Kristin Newby, MD; David Waters, MD; Eric Vittinghoff, PhD; Nanette Wenger, MD; for the HERS Research Group

JAMA. 2002;288:49-57.

Context  The Heart and Estrogen/progestin Replacement Study (HERS) found no overall reduction in risk of coronary heart disease (CHD) events among postmenopausal women with CHD. However, in the hormone group, findings did suggest a higher risk of CHD events during the first year, and a decreased risk during years 3 to 5.

Objective  To determine if the risk reduction observed in the later years of HERS persisted and resulted in an overall reduced risk of CHD events with additional years of follow-up.

Design and Setting  Randomized, blinded, placebo-controlled trial of 4.1 years' duration (HERS) and subsequent unblinded follow-up for 2.7 years (HERS II) conducted at outpatient and community settings at 20 US clinical centers.

Participants  A total of 2763 postmenopausal women with CHD and average age of 67 years at enrollment in HERS; 2321 women (93% of those surviving) consented to follow-up in HERS II.

Intervention  Participants were randomly assigned to receive 0.625 mg/d of conjugated estrogens and 2.5 mg of medroxyprogesterone acetate (n = 1380), or placebo (n = 1383) during HERS; open-label hormone therapy was prescribed at personal physicians' discretion during HERS II. The proportions with at least 80% adherence to hormones declined from 81% (year 1) to 45% (year 6) in the hormone group, and increased from 0% (year 1) to 8% (year 6) in the placebo group.

Main Outcome Measures  The primary outcome was nonfatal myocardial infarction and CHD death. Secondary cardiovascular events were coronary revascularization, hospitalization for unstable angina or congestive heart failure, nonfatal ventricular arrhythmia, sudden death, stroke or transient ischemic attack, and peripheral arterial disease.

Results  There were no significant decreases in rates of primary CHD events or secondary cardiovascular events among women assigned to the hormone group compared with the placebo group in HERS, HERS II, or overall. The unadjusted relative hazard (RH) for CHD events in HERS was 0.99 (95% confidence interval [CI], 0.81-1.22); HERS II, 1.00 (95% CI, 0.77-1.29); and overall, 0.99 (0.84-1.17). The overall RHs were similar after adjustment for potential confounders and differential use of statins between treatment groups (RH, 0.97; 95% CI, 0.82-1.14), and in analyses restricted to women who were adherent to randomized treatment assignment (RH, 0.96; 95% CI, 0.77-1.19).

Conclusions  Lower rates of CHD events among women in the hormone group in the final years of HERS did not persist during additional years of follow-up. After 6.8 years, hormone therapy did not reduce risk of cardiovascular events in women with CHD. Postmenopausal hormone therapy should not be used to reduce risk for CHD events in women with CHD.

Author Affiliations: Departments of Epidemiology and Biostatistics (Drs Grady, Hulley, and Vittinghoff) and Medicine (Dr Waters), University of California, San Francisco; Department of Internal Medicine/Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (Dr Herrington); Division of Cardiovascular Disease, Department of Medicine, University of Alabama, Birmingham (Dr Bittner); Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Md (Dr Blumenthal); Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill (Dr Davidson); Departments of Health Research and Policy, and of Medicine, Stanford University School of Medicine, Palo Alto, Calif (Dr Hlatky); Department of Medicine, George Washington University, Washington, DC (Dr Hsia); Division of Cardiology, Cedars Sinai and UCLA School of Medicine, Los Angeles, Calif (Dr Khan); Department of Medicine, Baylor College of Medicine, Houston, Tex (Dr Herd); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (Dr Newby); and Department of Medicine, Emory University School of Medicine, Atlanta, Ga (Dr Wenger).

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