EVTET, 2000 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of combined estrogen and progestogen versus placebo in postmenopausal women younger than 70 years who had suffered previous DVT or PE


Thromb Haemost 2000;84:961-7  

Studied treatment 2 mg estradiol plus 1 mg norethisterone acetate, 1 tablet daily
Control treatment placebo
Age (years) 55.8 y

Patients postmenopausal women younger than 70 years who had suffered previous DVT or PE
Group sizes71 / 69
Inclusion criteriaPrevious VTE verified by venography or ultrasound in cases of DVT, and lung-scan, helical computed tomography, or angiography in cases of PE; no natural menstruation for at least one year
Exclusion criteriacurrent use or use of anticoagulants within the last three months; familial antithrombin deficiency; any type of malignant diseases including known, suspected or past history of carcinoma of the breast; acute or chronic liver disease or history of liver disease in which liver function tests had failed to return to normal; porphyria, known drug abuse or alcoholism; life expectancy less than two years
type of prevention (secondary prevention
diabetes (%) 2.1%
hypertension (%) 17.1%
hyperlipidemia (%)
BMI (kg/m²) 27.1
Hysterectomy (%)
Oophorectomy (%)

Blindness double-blind Inclusion period feb 1996 - sep 1998
Follow-up duration 24 months Centers single center
Lost to FU geographical localisation Norway
Primary endpoint recurrent deep venous thrombosis or pulmonary embolism Design Parallel groups
PeriodeInclusionfeb 1996 - sep 1998

EndpointX1N1X0N0TE95% CI PE 3 71 1 69 Out of scale2,92[0,30; 28,73] all cause death - 71 - 69 no data CV events - 71 - 69 no data Cv death - 71 - 69 no data Coronary events (CHD) - 71 - 69 no data non fatal MI - 71 - 69 no data stroke - 71 - 69 no data venous thromboembolism 8 71 1 69 Out of scale7,77[0,95; 63,93]0,22,01,0

Høibraaten E, Qvigstad E, Arnesen H, Larsen S, Wickstrøm E, Sandset PM Increased risk of recurrent venous thromboembolism during hormone replacement therapy--results of the randomized, double-blind, placebo-controlled estrogen in venous thromboembolism trial (EVTET). Thromb Haemost 2000;84:961-7     [PMID: 11154141]   link to pdf   add to Mendeley  

Registering number (see trial on clinicaltrials.gov)
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