32278
document
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 . OBJECTIVES To compare the efficacy and safety of fondaparinux in conjunction with intermittent pneumatic compression vs. intermittent pneumatic compression alone in this context . PATIENTS AND 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 .
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Intervention_Pharmacological
Fondaparinux combined with intermittent pneumatic compression
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Intervention_Physical
intermittent pneumatic compression alone
32281
Intervention_Pharmacological
fondaparinux in conjunction with intermittent pneumatic compression
32282
Intervention_Physical
intermittent pneumatic compression alone
32283
Intervention_Control
placebo-controlled
32284
Intervention_Pharmacological
fondaparinux
32285
Intervention_Control
placebo
32286
Intervention_Physical
intermittent pneumatic compression
32287
Intervention_Pharmacological
fondaparinux-treated
32288
Intervention_Control
placebo-treated
32289
Intervention_Pharmacological
Fondaparinux
32290
Intervention_Pharmacological
fondaparinux-treated
32291
Intervention_Control
placebo-treated
32292
Intervention_Pharmacological
fondaparinux
32293
Intervention_Control
placebo
32294
Intervention_Pharmacological
intermittent pneumatic compression , fondaparinux
32295
Intervention_Physical
pneumatic compression alone
32296
Intervention_Control
placebo
32297
Outcome_Physical
venous thromboembolism
32298
Outcome_Physical
venous thromboembolism
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Physical
venous thromboembolism up to day 10 .
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Outcome_Physical
major bleeding
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Outcome_Mortality
all-cause mortality
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Outcome_Physical
venous thromboembolism rate
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Outcome_Physical
proximal deep vein thrombosis rate
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Outcome_Physical
Major bleeds
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Outcome_Mortality
died
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Outcome_Physical
venous thromboembolism
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Outcome_Physical
low bleeding risk
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Participant_Condition
venous thromboembolism after abdominal surgery :
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Participant_Condition
venous thromboembolism
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Participant_Condition
after abdominal surgery
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Participant_Age
Patients aged at least 40 years undergoing abdominal surgery
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Participant_Condition
patients undergoing abdominal surgery and receiving intermittent pneumatic compression