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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.
J Thromb Haemost. 2014 Jan 27;
Authors: Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P, The MAGELLAN Study Group
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: 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× 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: VTE frequency was 3.5-fold greater in patients with high D-dimer concentrations. Multivariate analysis showed D-dimer was an independent predictor of VTE risk (odds ratio 2.29 [95% confidence interval 1.75-2.98]), and was similarly predictive for VTE to established risk factors, e.g. 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 VTE risk for whom extended anticoagulant prophylaxis may provide greater benefit than those with low D-dimer concentrations. This article is protected by copyright. All rights reserved.
PMID: 24460645 [PubMed - as supplied by publisher]