Authors: TURPIE, A. G. G.¹; BAUER, K. A.²; CAPRINI, J. A.³; COMP, P. C.⁴; GENT, M.⁵; MUNTZ, J. E.⁶

Source: Journal of Thrombosis and Haemostasis, Volume 5, Number 9, September 2007 , pp. 1854-1861(8)

Publisher: Wiley-Blackwell

Abstract:

Summary. 

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.

Keywords: abdominal surgery; clinical trial; fondaparinux; intermittent pneumatic compression; prevention; venous thromboembolism

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1538-7836.2007.02657.x

Affiliations: 1: Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada 2: Beth Israel Deaconess Medical Center and VA Boston Healthcare System, Harvard Medical School, Boston, MA, USA 3: Northwestern University Feinberg School of Medicine, Chicago, IL, USA 4: College of Medicine, University of Oklahoma, Oklahoma City, OK, USA 5: Henderson Research Centre, McMaster University, Hamilton, ON, Canada 6: Baylor College of Medicine, Houston, TX, USA

Publication date: 2007-09-01

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