D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial.
BACKGROUND
D-dimer concentrations have not been evaluated extensively as a predictor of increased venous thromboembolism (VTE) risk in acutely ill, hospitalized medical patients.


OBJECTIVE
To analyze the relationships between D-dimer concentration, VTE and bleeding in the MAGELLAN trial (NCT00571649).


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.
King's College Hospital, London, UK.
A T
AT
Cohen
T E
TE
Spiro
A C
AC
Spyropoulos
Y H
YH
Desanctis
M
M
Homering
H R
HR
Büller
L
L
Haskell
D
D
Hu
R
R
Hull
A
A
Mebazaa
G
G
Merli
S
S
Schellong
V F
VF
Tapson
P
P
Burton
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000378:metabolism*; D006470:Hemorrhage; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D015999:Multivariate Analysis; D012307:Risk Factors; D000069552:Rivaroxaban; D013876:Thiophenes / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000097:blood* / Q000175:diagnosis*
D000925:Anticoagulants; D017984:Enoxaparin; D005338:Fibrin Fibrinogen Degradation Products; D009025:Morpholines; D013876:Thiophenes; C036309:fibrin fragment D; D000069552:Rivaroxaban
D-dimer; enoxaparin; hospitalization; rivaroxaban; venous thromboembolism