TY - JOUR
T1 - The EFFORT trial
T2 - Preoperative enoxaparin versus postoperative fondaparinux for thromboprophylaxis in bariatric surgical patients: A randomized double-blind pilot trial
AU - Steele, Kimberley E.
AU - Canner, Joseph
AU - Prokopowicz, Gregory
AU - Verde, Franco
AU - Beselman, Aleksandra
AU - Wyse, Ransom
AU - Chen, Junnan
AU - Streiff, Michael
AU - Magnuson, Thomas
AU - Lidor, Anne
AU - Schweitzer, Michael
N1 - Funding Information:
Study materials (drug) and/or additional financial support were provided by GlaxoSmithKline. Financial supporters had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript .
Publisher Copyright:
© 2015 Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
PY - 2015/5/1
Y1 - 2015/5/1
N2 - Background Prophylaxis for venous thromboembolism is routinely performed for all patients undergoing bariatric surgery. However, there is disagreement regarding the optimal dosing and duration of anticoagulant therapy. Furthermore, there is little data regarding the incidence of asymptomatic deep venous thrombosis (DVT) in this population. Our objective was to conduct a pilot randomized double blind study to evaluate the pharmacodynamic parameters of 2 different anticoagulation medications (enoxaparin and fondaparinux) administered to patients undergoing bariatric surgery. Methods From July 2010 to August 2013, 198 consecutive bariatric surgery patients from an academic institution were randomized in a double blinded manner to receive either 40mg enoxaparin twice daily or 5mg fondaparinux sodium once daily. Antifactor Xa activity was measured on all patients in both study arms, 3 hours after the first dose (on the day of the operation), immediately before the second dose (postoperative day one), and 3 hours after the second dose. At the routine 2 week postoperative visit, patients underwent magnetic resonance venography (MRV) to detect DVT. The primary outcome was attainment of therapeutic antifactor Xa levels. The secondary outcome was DVT, as detected by MRV. Safety outcomes were perioperative bleeding, perioperative complications, and death. Results Of 198 patients randomized, 177 underwent MRV and 137 had interpretable antifactor Xa levels. Nearly half of the patients (47.4%) did not attain target prophylactic antifactor Xa levels. Adequate antifactor Xa levels were more common with fondaparinux (74.2%) than with enoxaparin (32.4%). Antifactor Xa levels were also associated with preoperative D-dimer level. 4 of the 175 patients who underwent MRV developed DVT, 2 in each arm of the study. No major adverse events occurred in either arm. Conclusion Fondaparinux was much more likely to produce target prophylactic antifactor Xa levels than enoxaparin. Both regimens appear to be equally effective at reducing the risk of DVT. Further prospective studies are needed to determine the optimal DVT prophylaxis regimen in the bariatric surgical population.
AB - Background Prophylaxis for venous thromboembolism is routinely performed for all patients undergoing bariatric surgery. However, there is disagreement regarding the optimal dosing and duration of anticoagulant therapy. Furthermore, there is little data regarding the incidence of asymptomatic deep venous thrombosis (DVT) in this population. Our objective was to conduct a pilot randomized double blind study to evaluate the pharmacodynamic parameters of 2 different anticoagulation medications (enoxaparin and fondaparinux) administered to patients undergoing bariatric surgery. Methods From July 2010 to August 2013, 198 consecutive bariatric surgery patients from an academic institution were randomized in a double blinded manner to receive either 40mg enoxaparin twice daily or 5mg fondaparinux sodium once daily. Antifactor Xa activity was measured on all patients in both study arms, 3 hours after the first dose (on the day of the operation), immediately before the second dose (postoperative day one), and 3 hours after the second dose. At the routine 2 week postoperative visit, patients underwent magnetic resonance venography (MRV) to detect DVT. The primary outcome was attainment of therapeutic antifactor Xa levels. The secondary outcome was DVT, as detected by MRV. Safety outcomes were perioperative bleeding, perioperative complications, and death. Results Of 198 patients randomized, 177 underwent MRV and 137 had interpretable antifactor Xa levels. Nearly half of the patients (47.4%) did not attain target prophylactic antifactor Xa levels. Adequate antifactor Xa levels were more common with fondaparinux (74.2%) than with enoxaparin (32.4%). Antifactor Xa levels were also associated with preoperative D-dimer level. 4 of the 175 patients who underwent MRV developed DVT, 2 in each arm of the study. No major adverse events occurred in either arm. Conclusion Fondaparinux was much more likely to produce target prophylactic antifactor Xa levels than enoxaparin. Both regimens appear to be equally effective at reducing the risk of DVT. Further prospective studies are needed to determine the optimal DVT prophylaxis regimen in the bariatric surgical population.
KW - Anticoagulation
KW - Bariatric surgery
KW - Clinical trial
KW - Prophylaxis
KW - Venous thromboembolism
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UR - http://www.scopus.com/inward/citedby.url?scp=84931578813&partnerID=8YFLogxK
U2 - 10.1016/j.soard.2014.10.003
DO - 10.1016/j.soard.2014.10.003
M3 - Article
C2 - 25620436
AN - SCOPUS:84931578813
SN - 1550-7289
VL - 11
SP - 672
EP - 683
JO - Surgery for Obesity and Related Diseases
JF - Surgery for Obesity and Related Diseases
IS - 3
ER -