Fondaparinux plus compression prevents VTE.(Gynecologic Surgery)

PALM SPRINGS, CALIF. -- Once-daily fondaparinux 2.5 mg for 5-7 days combined with pneumatic compression was significantly more effective than intermittent pneumatic compression alone for preventing venous thrombosis after elective major abdominal surgery, Dr. Joseph A. Caprini reported at the annual meeting of the Society of Gynecologic Oncologists.

That marks the chief conclusion of the APOLLO study, a multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy of fondaparinux and intermittent pneumatic compression (IPC) vs. IPC alone for preventing venous thromboembolic events (VTE) after major abdominal surgery. The study is the largest of its kind to date.

"This trial has taught us two really important things," said Dr. Caprini, professor of surgery at Northwestern University, Chicago. "In patients who aren't at much risk, don't use very much [low-molecular-weight heparin]. In patients who have really high risk, use the modality that has been shown to give the most effective reduction in venous thromboembolism."

He and his associates randomized 1,309 patients, who were older than age 40 years and underwent major abdominal surgery, to receive either fondaparinux (2.5 mg) or a placebo shot of saline subcutaneously once a day starting 6-8 hours after surgery and then once daily for 5-7 days. Every patient in the study received IPC devices per each hospital's protocol. These included calf-high devices and thigh-high devices. Stockings were also used, but foot pumps were not allowed.

Of 1,309 patients, only 842 (64%) were evaluable. About half of the patients were women, the average age was 60 years, and most were white. "The procedures were mostly gastrointestinal procedures, which included laparoscopic cholecystectomy," Dr. Caprini said. Nearly half (40%) underwent cancer surgery, 18% underwent urologic surgery, and 9% underwent gynecologic surgery.

The majority of patients were at moderate risk of VTE, based on guidelines from the American ...