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Clinical Relevance of Bleeding Index

Clinical Relevance of Bleeding Index We read with interest the report of the recent meta-analysis by Turpie and colleagues1 of data from 4 randomized, double-blind clinical trials in which patients undergoing major orthopedic surgery were randomized to receive fondaparinux sodium or enoxaparin sodium to prevent venous thromboembolism (VTE). The authors report that fondaparinux reduced the risk of VTE by approximately 50% but that it also increased the risk of major bleeding by 53%. They point out that the difference in bleeding events was accounted for mainly by an excess risk among fondaparinux-treated patients of major bleeding with a "bleeding index of 2 or more" (number of units of packed red blood cells or whole blood transfused plus prebleeding minus postbleeding hemoglobin [grams per deciliter] values). They suggest that this measure is not "clinically relevant" but provide no data to substantiate this claim. To investigate this issue, we compared length of stay and total hospital charges among 23 298 major orthopedic surgery patients from over 100 US acute care hospitals with and without bleeding indexes of 2 or more (n = 394 and n = 22 904, respectively). We used the same definition of this measure as was used in the fondaparinux clinical trials program and excluded patients with fatal bleeding, bleeding into a critical organ, and bleeding leading to reoperation from the comparison. Mean length of stay was 2.8 days longer (95% confidence interval, 2.5-3.1 days) among patients with bleeding indexes of 2 or more vs those without major bleeding. Total inpatient charges were $9870 higher (95% confidence interval, $8865-$10 875) among the former group. The difference was consistent across all procedures (total hip, major knee, and hip fracture). While the reduction in VTE with fondaparinux therapy is impressive, the benefits of this new antithrombotic must be weighed against its associated risks. These risks may be more "clinically relevant" than Turpie and colleagues1 believe. Box Section Ref ID Drs Oster and Vera have received consulting fees from Organon Sanofi-Synthelabo and Aventis Pharmaceuticals, which market Arixyta and Lovenox, respectively. References 1. Turpie AGBauer KAEriksson BILassen MRfor the Steering Committees of the Pentasaccharide Orthopedic Prophylaxis Studies, Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med. 2002;1621833- 1840PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Clinical Relevance of Bleeding Index

Oster, Gerry; Vera, Montserrat
Archives of Internal Medicine , Volume 163 (22) – Dec 8, 2003
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Clinical Relevance of Bleeding Index

Abstract

We read with interest the report of the recent meta-analysis by Turpie and colleagues1 of data from 4 randomized, double-blind clinical trials in which patients undergoing major orthopedic surgery were randomized to receive fondaparinux sodium or enoxaparin sodium to prevent venous thromboembolism (VTE). The authors report that fondaparinux reduced the risk of VTE by approximately 50% but that it also increased the risk of major bleeding by 53%. They point out that the difference in bleeding...
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Publisher
American Medical Association
Copyright
Copyright © 2003 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinte.163.22.2794-a
Publisher site
See Article on Publisher Site

Abstract

We read with interest the report of the recent meta-analysis by Turpie and colleagues1 of data from 4 randomized, double-blind clinical trials in which patients undergoing major orthopedic surgery were randomized to receive fondaparinux sodium or enoxaparin sodium to prevent venous thromboembolism (VTE). The authors report that fondaparinux reduced the risk of VTE by approximately 50% but that it also increased the risk of major bleeding by 53%. They point out that the difference in bleeding events was accounted for mainly by an excess risk among fondaparinux-treated patients of major bleeding with a "bleeding index of 2 or more" (number of units of packed red blood cells or whole blood transfused plus prebleeding minus postbleeding hemoglobin [grams per deciliter] values). They suggest that this measure is not "clinically relevant" but provide no data to substantiate this claim. To investigate this issue, we compared length of stay and total hospital charges among 23 298 major orthopedic surgery patients from over 100 US acute care hospitals with and without bleeding indexes of 2 or more (n = 394 and n = 22 904, respectively). We used the same definition of this measure as was used in the fondaparinux clinical trials program and excluded patients with fatal bleeding, bleeding into a critical organ, and bleeding leading to reoperation from the comparison. Mean length of stay was 2.8 days longer (95% confidence interval, 2.5-3.1 days) among patients with bleeding indexes of 2 or more vs those without major bleeding. Total inpatient charges were $9870 higher (95% confidence interval, $8865-$10 875) among the former group. The difference was consistent across all procedures (total hip, major knee, and hip fracture). While the reduction in VTE with fondaparinux therapy is impressive, the benefits of this new antithrombotic must be weighed against its associated risks. These risks may be more "clinically relevant" than Turpie and colleagues1 believe. Box Section Ref ID Drs Oster and Vera have received consulting fees from Organon Sanofi-Synthelabo and Aventis Pharmaceuticals, which market Arixyta and Lovenox, respectively. References 1. Turpie AGBauer KAEriksson BILassen MRfor the Steering Committees of the Pentasaccharide Orthopedic Prophylaxis Studies, Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med. 2002;1621833- 1840PubMedGoogle ScholarCrossref

Journal

Archives of Internal Medicine – American Medical Association

Published: Dec 8, 2003

Keywords: hemorrhage

References

  • Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies.
    Lassen MR; Arch Intern Med.

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