Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison.
BACKGROUND
The benefit of combined mechanical and pharmacologic methods for venous thromboembolism prevention after abdominal surgery has not been clearly established.


OBJECTIVE
To compare the efficacy and safety of fondaparinux in conjunction with intermittent pneumatic compression vs. intermittent pneumatic compression alone in this context.


METHODS
This was a randomized, double-blind, placebo-controlled superiority trial. Patients aged at least 40 years undergoing abdominal surgery were randomized to receive either fondaparinux 2.5 mg or placebo s.c. for 5-9 days, starting 6-8 h postoperatively. All patients received intermittent pneumatic compression. The primary efficacy outcome was venous thromboembolism up to day 10. The main safety outcomes were major bleeding and all-cause mortality. Follow-up lasted 32 days.


RESULTS
Of the 1309 patients randomized, 842 (64.3%) were evaluable for efficacy. The venous thromboembolism rate was 1.7% (7/424) in the fondaparinux-treated patients and 5.3% (22/418) in the placebo-treated patients (odds ratio reduction 69.8%; 95% confidence interval 27.9-87.3; P = 0.004). Fondaparinux significantly reduced the proximal deep vein thrombosis rate from 1.7% (7/417) to 0.2% (1/424; P = 0.037). Major bleeds occurred in 1.6% (10/635) and 0.2% (1/650) of fondaparinux-treated and placebo-treated patients, respectively (P = 0.006), none being fatal or involving a critical organ. By day 32, eight patients (1.3%) receiving fondaparinux and five (0.8%) receiving placebo had died.


CONCLUSIONS
In patients undergoing abdominal surgery and receiving intermittent pneumatic compression, fondaparinux 2.5 mg reduced the venous thromboembolism rate by 69.8% as compared to pneumatic compression alone, with a low bleeding risk as compared to placebo.
Turpie
A G G
AG
Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada. turpiea@mcmaster.ca
Bauer
K A
KA
Caprini
J A
JA
Comp
P C
PC
Gent
M
M
Muntz
J E
JE
D000005:Abdomen / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D000077425:Fondaparinux; D006801:Humans; D048228:Intermittent Pneumatic Compression Devices; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011134:Polysaccharides / Q000009:adverse effects / Q000627:therapeutic use*; D013514:Surgical Procedures, Operative / Q000009:adverse effects*; D013923:Thromboembolism / Q000517:prevention & control*; D016896:Treatment Outcome
D000925:Anticoagulants; D010919:Placebos; D011134:Polysaccharides; D000077425:Fondaparinux