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A correction has been published: N Engl J Med 2006;355(26):2797.

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Volume 355:1780-1789 October 26, 2006 Number 17
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D-Dimer Testing to Determine the Duration of Anticoagulation Therapy
Gualtiero Palareti, M.D., Benilde Cosmi, M.D., Ph.D., Cristina Legnani, D.Sci., Ph.D., Alberto Tosetto, M.D., Carlotta Brusi, M.D., Alfonso Iorio, M.D., Vittorio Pengo, M.D., Angelo Ghirarduzzi, M.D., Corrado Pattacini, M.D., Sophie Testa, M.D., Anthonie W.A. Lensing, M.D., Armando Tripodi, D.Sci., Ph.D., for the PROLONG Investigators

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ABSTRACT

Background The optimal duration of oral anticoagulation in patients with idiopathic venous thromboembolism is uncertain. Testing of D-dimer levels may play a role in the assessment of the need for prolonged anticoagulation.

Methods We performed D-dimer testing 1 month after the discontinuation of anticoagulation in patients with a first unprovoked proximal deep-vein thrombosis or pulmonary embolism who had received a vitamin K antagonist for at least 3 months. Patients with a normal D-dimer level did not resume anticoagulation, whereas those with an abnormal D-dimer level were randomly assigned either to resume or to discontinue treatment. The study outcome was the composite of recurrent venous thromboembolism and major bleeding during an average follow-up of 1.4 years.

Results The D-dimer assay was abnormal in 223 of 608 patients (36.7%). A total of 18 events occurred among the 120 patients who stopped anticoagulation (15.0%), as compared with 3 events among the 103 patients who resumed anticoagulation (2.9%), for an adjusted hazard ratio of 4.26 (95% confidence interval [CI], 1.23 to 14.6; P=0.02). Thromboembolism recurred in 24 of 385 patients with a normal D-dimer level (6.2%). Among patients who stopped anticoagulation, the adjusted hazard ratio for recurrent thromboembolism among those with an abnormal D-dimer level, as compared with those with a normal D-dimer level, was 2.27 (95% CI, 1.15 to 4.46; P=0.02).

Conclusions Patients with an abnormal D-dimer level 1 month after the discontinuation of anticoagulation have a significant incidence of recurrent venous thromboembolism, which is reduced by the resumption of anticoagulation. The optimal course of anticoagulation in patients with a normal D-dimer level has not been clearly established. (ClinicalTrials.gov number, NCT00264277 [ClinicalTrials.gov] .)


Source Information

From the S. Orsola-Malpighi University Hospital, Bologna, (G.P., B.C., C.L., C.B.); S. Bortolo Hospital, Vicenza (A. Tosetto); the University of Perugia, Perugia (A.I.); the University Hospital, Padua (V.P.); Arcispe-dale Santa Maria Nuova, Reggio Emilia (A.G.); General Hospital, Parma (C.P.); General Hospital, Cremona (S.T.); and Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Istituto di Ricovero e Cura a Carattere Scientifico, Maggiore Hospital, Milan (A. Tripodi) — all in Italy; and the Academic Medical Center, Amsterdam (A.W.A.L.).

Address reprint requests to Dr. Palareti at the Department of Angiology and Blood Coagulation, S. Orsola-Malpighi University Hospital, Via Albertoni 15, 40138 Bologna, Italy, or at palareti{at}tin.it.

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Related Letters:

D-Dimer and Duration of Anticoagulation
Pernod G., Sevestre M.-A., Labarere J., Mannarino E., Schillaci G., Kevorkian J.-P., Virally M.-L., Bergmann J.-F., Glynn R. J., Goldhaber S. Z., Ridker P. M., Palareti G., Cosmi B., Iorio A.
Extract | Full Text | PDF  
N Engl J Med 2007; 356:421-423, Jan 25, 2007. Correspondence

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