SEARCH:   Advanced

Blood, 1 May 2008, Vol. 111, No. 9, pp. 4471-4476. Prepublished online as a Blood First Edition Paper on March 3, 2008; DOI 10.1182/blood-2007-11-123711. This Article Full Text (PDF) All Versions of this Article: blood-2007-11-123711v1 111/9/4471    most recent Alert me when this article is cited Alert me if a correction is posted 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 Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Google Scholar Articles by Levi, M. Articles by Rosendaal, F. R PubMed PubMed Citation Articles by Levi, M. Articles by Rosendaal, F. R Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted November 16, 2007 Accepted February 19, 2008 Bleeding in patients receiving vitamin K-antagonists that would have been excluded from trials on which the indication for anticoagulation was based Marcel Levi*, G. Kees Hovingh, Suzanne C Cannegieter, Marinus R Vermeulen, Harry R Buller, and Frits R Rosendaal Department of Internal Medicine/Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands Department of Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands * Corresponding author; email: m.m.levi{at}amc.uva.nl. Vitamin K antagonists (VKA) are effective antithrombotic agents and advocated in guidelines for the management of cardiovascular disease. However, in the trials underlying these guidelines, many patients were excluded. We performed a case-control study in 993 patients receiving VKA, who required hospitalization for bleeding, and contrasted them to 993 matched control patients on VKA, who were hospitalized for an infection. We analyzed whether patients and controls would have been eligible for the clinical trials on which their indication for anticoagulation was based, and estimated the risk of hemorrhage associated with exclusion criteria as applied in those trials. About a quarter (23% (95% CI 21-26%)) of controls had one or more exclusion criteria for the trials supporting the use of anticoagulation for their condition. 40% of patients presenting with bleeding had one or more exclusion criteria (95% CI 37-43%). Having one exclusion criterion resulted in a 2.9-fold increased risk of bleeding (95% CI 2.2-3.9), and this risk increased sharply when more than one exclusion criterion was present. VKA are often prescribed to patients who would not have qualified for clinical trials and in these patients a careful consideration should be made regarding the expected efficacy and the risk of bleeding. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: Why Is Warfarin Such a Dangerous Drug? Journal Watch Oncology and Hematology, June 10, 2008; 2008(610): 1 - 1. [Full Text]

	Blood Online is supported in part by Genentech BioOncology and Biogen Idec
	Copyright © 2008 by American Society of Hematology         Online ISSN: 1528-0020