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The Combination of fondaparinux and Intermittent Pneumatic Compression is Superior to Intermittent Pneumatic Compression Alone for Prevention of Venous Thromboembolism in Patients After Abdominal Surgery
Gregory Piazza, M.D.
Provided by NATF
Posted on ClotCare January, 2008*
Reference: Turpie AG, Bauer KA, Caprini JA, Comp PC, Gent M, Muntz, JE; on behalf of the APOLLO Investigators. Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison. Journal of Thrombosis and Haemostasis 2007; 5: 1854–1861.
Is a combined modality approach of prophylactic anticoagulation with fondaparinux and mechanical prophylaxis with intermittent pneumatic compression superior to mechanical prophylaxis alone in the prevention of venous thromboembolism (VTE) after abdominal surgery? This randomized, double-blind, placebo-controlled superiority trial randomized 1,309 patients who had undergone abdominal surgery to 2.5 mg of subcutaneously administered fondaparinux or placebo in addition to intermittent pneumatic compression. Deep vein thrombosis (DVT) was diagnosed by bilateral contrast venography between days 5 and 10. The combination of fondaparinux and intermittent pneumatic compression resulted in a lower rate of VTE compared with mechanical prophylaxis alone (1.7% versus 5.3%) with an associated odds ratio reduction of 69.8% (95% confidence interval 27.9-87.3; p = 0.004). While the combination group also demonstrated significant reductions in proximal DVT and a composite of any VTE or death, there was no difference in the rate of symptomatic VTE between the two groups. A similarly low rate of pulmonary embolism was observed in both groups. Although the frequency of major bleeding was high in the combination group (1.6% versus 0.2%, p = 0.006), no bleeding episodes were fatal or involving a critical organ.
While previous studies have established the safety and efficacy of fondaparinux in postoperative patients, the APOLLO study demonstrates the superiority of a combination approach that utilizes pharmacological and mechanical modalities. The superiority of combined pharmacological and mechanical prophylaxis persisted regardless of gender, age, obesity, number of VTE risk factors, duration of surgery, type of surgery, and whether or not surgery was performed for malignancy. While significantly increased compared with the placebo group, the 1.6% rate of major bleeding in the combination group was within the lower range of rates reported in recent meta-analyses supporting the safety and efficacy of pharmacological prophylaxis.
The APOLLO study suggests that a prophylactic strategy that combines pharmacological and mechanical modalities is a safe and effective option for reducing the risk of VTE even further among patients undergoing abdominal surgery. Further studies should focus on determining whether the combination of mechanical and pharmacological prophylaxis can safely lower the rate of VTE compared with standard pharmacological prophylaxis with unfractionated heparin, low-molecular weight heparin, or fondaparinux.
Dr. Piazza completed medical Internship and Residency at the Beth Israel Deaconess Medical Center in Boston, Massachusetts. He also served as a Chief Medical Resident at the Beth Israel Deaconess Medical Center. Dr. Piazza is currently a third year clinical fellow in the Cardiovascular Division at the Beth Israel Deaconess Medical Center. His Clinical research is undertaken simultaneously at the Venous Thromboembolism Research Group, where he is focusing on characteristics of hospitalized medical patients with DVT and complications of anticoagulation management.
This posting originally appeared on the website of the North American Thrombosis Forum (NATF) and has been provided on ClotCare with NATF's permission. See www.natfonline.org for more information about NATF.
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