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QUESTION: In women with coronary artery disease, does hormone replacement therapy (HRT) (oestrogen plus progestin) increase the risk for venous thromboembolism (VTE)?
Design
Randomised (unclear allocation concealment*), blinded (patients, investigators, and outcome assessors),* placebo controlled trial with a mean follow up of 4.1 years (Heart and Estrogen/progestin Replacement Study [HERS]).
Setting
20 US outpatient and community settings.
Patients
2763 postmenopausal women between 44 and 79 years of age (mean age 67 y, 89% white) who had established coronary artery disease and who had not had a hysterectomy. Exclusion criteria were recent coronary events; recent use of hormone therapy; history of VTE, breast cancer, or endometrial cancer; uncontrolled hypertension; diabetes; or other life …