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Four-week prophylaxis safe, effective after abdominal, pelvic surgery
ISTH 2009
Extending the length of prophylaxis with bemiparin after cancer abdominal or pelvic surgery was more effective and safer than one week of prophylaxis, according to the results of a late-breaking abstract presented this week at the XXII Congress of the International Society on Thrombosis and Hemostasis.
Vijay V. Kakkar, MD, director of the Thrombosis Research Institute in London, presented the results of the CANBESURE trial.
“Four-week prophylaxis with bemiparin after abdominal and pelvic surgery significantly reduced the risk of major venous thromboembolism without increasing the risk of major bleeding complications,” Kakkar said.
The multicenter, randomized, double blind trial enrolled patients who were undergoing elective, open, curative or palliative abdominal or pelvic surgery for malignant disease on the gastrointestinal or genitourinary tract or the female reproductive organs.
Before randomization, all patients (n=703) were given 3,500 IU bemiparin once daily starting six hours after surgery for eight days. Patients were then randomly assigned to placebo or to an additional 20 days of 3,500 IU bemiparin.
The primary efficacy endpoint was the combined incidence of total symptomatic and asymptomatic deep vein thrombosis, nonfatal pulmonary embolism and deaths due to any cause. The primary safety endpoint was the incidence of major hemorrhage.
The primary efficacy endpoint occurred in 10.1% of the bemiparin group and 13.3% of the placebo group for an RR reduction of 24.4% (P=.263). Major venous thromboembolism — or venous thromboembolism-related death — occurred in 0.8% of the bemiparin group vs. 4.6% in the placebo group for an RR reduction of 82.4% (P=.0096).
Rates of major bleeding were similar between the two groups.
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