Bemiparin for thromboprophylaxis after benign gynecologic surgery: a randomized clinical trial

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Abstract

Background:

Venous thromboembolism (VTE) is the leading cause of mortality and morbidity in women following gynecologic surgery.

Objectives:

To determine the efficacy of a second-generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery.

Methods:

We performed a single-blind randomized controlled trial including women in the moderate-risk, high-risk and highest-risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1 : 1 ratio into parallel groups to receive either seven daily doses of 3500 IU of subcutaneous bemiparin or to a non-intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7 days and 30 days postoperatively for symptomatic VTE, which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE.

Results:

In total, 387 participants were randomized to the bemiparin group and 387 to the non-intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [CI] 0.002–0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [OR] 7.1; 95% CI 1.3–36.2), varicose veins (OR 16.8; 95% CI 3.1–76.2), and thrombophilia (OR 39.3; 95% CI 1.5–1006.7). There were no major bleeding events or side effects related to the use of bemiparin.

Conclusions:

Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery.

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