This Article Full Text Full Text (PDF) All Versions of this Article: 120/20/2006    most recent CIRCULATIONAHA.109.872630v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Google Scholar Articles by Eikelboom, J. W. Articles by O'Donnell, M. PubMed PubMed Citation Articles by Eikelboom, J. W. Articles by O'Donnell, M. Related Collections Deep vein thrombosis Heparin Other anticoagulants Related Article

(Circulation. 2009;120:2006-2011.)
© 2009 American Heart Association, Inc.

Vascular Medicine

Major Bleeding, Mortality, and Efficacy of Fondaparinux in Venous Thromboembolism Prevention Trials

John W. Eikelboom, MBBS, MSc; Daniel J. Quinlan, MBBS; Martin O'Donnell, MB, PhD

From the Thromboembolism Unit, Hamilton General Hospital, Hamilton, Ontario, Canada (J.W.E., M.O.); Department of Medicine, McMaster University, Hamilton, Ontario, Canada (J.W.E., M.O.); and Department of Radiology, King’s College Hospital, London, UK (D.J.Q.).

Correspondence to John W. Eikelboom, Thromboembolism Unit, Sixth Floor, McMaster Wing, Hamilton General Hospital, 237 Barton St E, Hamilton, Ontario, L8L 2X2, Canada. E-mail eikelbj{at}mcmaster.ca

Received April 11, 2009; accepted September 4, 2009.

Background— Bleeding is a strong predictor of death in patients hospitalized for arterial thrombosis who are treated with antithrombotic therapy, but the prognostic importance of bleeding in patients receiving antithrombotic prophylaxis for venous thromboembolism is uncertain.

Methods and Results— Using Cox proportional hazards modeling, we examined the association between major bleeding and death at 30 days using pooled individual patient data from 8 large randomized controlled trials (n=13 085) comparing fondaparinux with control (low-molecular-weight heparin or placebo) for the prophylaxis of venous thromboembolism in hospitalized surgical or medical patients. Patients who developed major bleeding were older, were more likely to be male, had a lower body weight and lower creatinine clearance, and were more likely to be receiving fondaparinux. At 30 days, the risk of death was 7-fold higher among patients with a major bleeding event (8.6% versus 1.7%; adjusted hazard ratio, 6.96; 95% confidence interval, 4.60 to 10.51). There was a consistent pattern of reduced mortality in patients treated with fondaparinux irrespective of whether patients experienced major bleeding (6.8% versus 11.4%; hazard ratio, 0.58; 95% confidence interval, 0.27 to 1.23) or no major bleeding (1.5% versus 1.9%; hazard ratio, 0.77; 95% confidence interval, 0.59 to 1.02; P for heterogeneity=0.47).

Conclusions— Major bleeding in hospitalized surgical and medical patients participating in venous thromboembolism prevention trials is a strong predictor of mortality.

---

 

CLINICAL PERSPECTIVE

Related Article:

Clinical Summaries
Circulation 2009 120: 1935-1936. [Extract] [Full Text]