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D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial.

AbstractBACKGROUND:
D-dimer concentrations have not been evaluated extensively as a predictor of increased venous thromboembolism (VTE) risk in acutely ill, hospitalized medical patients.
OBJECTIVES:
To analyze the relationships between D-dimer concentration, VTE and bleeding in the MAGELLAN trial (NCT00571649).
PATIENTS/METHODS:
This was a multicenter, randomized, controlled trial. Patients aged ≥ 40 years, hospitalized for acute medical illnesses with risk factors for VTE received subcutaneous enoxaparin 40 mg once daily for 10 ± 4 days then placebo up to day 35, or oral rivaroxaban 10 mg once daily for 35 ± 4 days. Patients (n = 7581) were grouped by baseline D-dimer ≤ 2 × or > 2 × the upper limit of normal. VTE and major plus non-major clinically relevant bleeding were recorded at day 10, day 35, and between days 11 and 35.
RESULTS:
The frequency of VTE was 3.5-fold greater in patients with high D-dimer concentrations. Multivariate analysis showed that D-dimer was an independent predictor of the risk of VTE (odds ratio 2.29 [95% confidence interval 1.75-2.98]), and had a similar association to established risk factors for VTE, for example cancer and advanced age. In the high D-dimer group, rivaroxaban was non-inferior to enoxaparin at day 10 and, unlike the low D-dimer group, superior to placebo at day 35 (P < 0.001) and days 11-35 (P < 0.001). In both groups, bleeding outcomes favored enoxaparin/placebo.
CONCLUSIONS:
Elevated baseline D-dimer concentrations may identify acutely ill, hospitalized medical patients at high risk of VTE for whom extended anticoagulant prophylaxis may provide greater benefit than for those with low D-dimer concentrations.
AuthorsA T Cohen, T E Spiro, A C Spyropoulos, Y H Desanctis, M Homering, H R Büller, L Haskell, D Hu, R Hull, A Mebazaa, G Merli, S Schellong, V F Tapson, P Burton, MAGELLAN Study Group
JournalJournal of thrombosis and haemostasis : JTH (J Thromb Haemost) Vol. 12 Issue 4 Pg. 479-87 (Apr 2014) ISSN: 1538-7836 [Electronic] England
PMID24460645 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© 2014 International Society on Thrombosis and Haemostasis.
Chemical References
  • Anticoagulants
  • Enoxaparin
  • Fibrin Fibrinogen Degradation Products
  • Morpholines
  • Thiophenes
  • fibrin fragment D
  • Rivaroxaban
Topics
  • Acute Disease
  • Adult
  • Aged
  • Anticoagulants (therapeutic use)
  • Enoxaparin (therapeutic use)
  • Female
  • Fibrin Fibrinogen Degradation Products (metabolism)
  • Hemorrhage
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Morpholines (therapeutic use)
  • Multivariate Analysis
  • Risk Factors
  • Rivaroxaban
  • Thiophenes (therapeutic use)
  • Time Factors
  • Treatment Outcome
  • Venous Thromboembolism (blood, diagnosis)

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