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

• DOI: 10.1111/jth.12515
• Publication Date: 2014-01-27T11:36:40Z
• 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
• Keywords: Adult; Male; 2. Zero hunger; Time Factors; Morpholines; Anticoagulants; Hemorrhage; Thiophenes; Venous Thromboembolism; Middle Aged; 3. Good health; Fibrin Fibrinogen Degradation Products; Hospitalization; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Rivaroxaban; Risk Factors; Acute Disease; Multivariate Analysis; Humans; Female; Enoxaparin; Aged

D-dimer concentrations have not been evaluated extensively as a predictor of increased venous thromboembolism (VTE) risk in acutely ill, hospitalized medical patients.To analyze the relationships between D-dimer concentration, VTE and bleeding in the MAGELLAN trial (NCT00571649).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.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.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.