Abstract | BACKGROUND:
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.
|
Authors | A 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 |
Journal | Journal of thrombosis and haemostasis : JTH
(J Thromb Haemost)
Vol. 12
Issue 4
Pg. 479-87
(Apr 2014)
ISSN: 1538-7836 [Electronic] England |
PMID | 24460645
(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)
|