Outcome of Patients with Venous Thromboembolism and Factor V Leiden or Prothrombin 20210 Carrier Mutations During the Course of Anticoagulation

I. Tzoran, M. Papadakis, B. Brenner, Á. Fidalgo, A. Rivas, P.S. Wells, O. Gavín, M.D. Adarraga, F. Moustafa, M. Monreal, H. Decousus, P. Prandoni, R. Barba, P. Di Micco, L. Bertoletti, A. Reis, M. Bosevski, H. Bounameaux, R. Malý, P. WellsM.A. Aibar, M. Alfonso, J.I. Arcelus, M. Barrón, B. Barrón-Andrés, J. Bascuñana, A. Blanco-Molina, T. Bueso, G. Cañada, I. Cañas, N. Chic, R. del Pozo, J. del Toro, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, C. Falgá, C. Fernández-Capitán, M.A. Fidalgo, C. Font, L. Font, P. Gallego, A. García, M.A. García, F. García-Bragado, A. Lorenzo, G. Antonucci, P. Ferrazzi, E. Grandone, C. Lodigiani, L. Rota

Research output: Contribution to journalArticlepeer-review


Background Individuals with factor V Leiden or prothrombin G20210A mutations are at a higher risk to develop venous thromboembolism. However, the influence of these polymorphisms on patient outcome during anticoagulant therapy has not been consistently explored. Methods We used the Registro Informatizado de Enfermedad TromboEmbólica database to compare rates of venous thromboembolism recurrence and bleeding events occurring during the anticoagulation course in factor V Leiden carriers, prothrombin mutation carriers, and noncarriers. Results Between March 2001 and December 2015, 10,139 patients underwent thrombophilia testing. Of these, 1384 were factor V Leiden carriers, 1115 were prothrombin mutation carriers, and 7640 were noncarriers. During the anticoagulation course, 160 patients developed recurrent deep vein thrombosis and 94 patients developed pulmonary embolism (16 died); 154 patients had major bleeding (10 died), and 291 patients had nonmajor bleeding. On multivariable analysis, factor V Leiden carriers had a similar rate of venous thromboembolism recurrence (adjusted hazard ratio [HR], 1.16; 95% confidence interval [CI], 0.82-1.64), half the rate of major bleeding (adjusted HR, 0.50; 95% CI, 0.25-0.99) and a nonsignificantly lower rate of nonmajor bleeding (adjusted HR, 0.66; 95% CI, 0.43-1.01) than noncarriers. Prothrombin mutation carriers and noncarriers had a comparable rate of venous thromboembolism recurrence (adjusted HR, 1.00; 95% CI, 0.68-1.48), major bleeding (adjusted HR, 0.75; 95% CI, 0.42-1.34), and nonmajor bleeding events (adjusted HR, 1.10; 95% CI, 0.77-1.57). Conclusions During the anticoagulation course, factor V Leiden carriers had a similar risk for venous thromboembolism recurrence and half the risk for major bleeding compared with noncarriers. This finding may contribute to decision-making regarding anticoagulation duration in selected factor V Leiden carriers with venous thromboembolism. © 2017
Original languageEnglish
Pages (from-to)482.e1-482.e9
JournalAmerican Journal of Medicine
Issue number4
Publication statusPublished - 2017


  • Anticoagulant therapy
  • Bleeding
  • Thrombophilia
  • Venous thromboembolism
  • anticoagulant agent
  • antivitamin K
  • blood clotting factor 5 Leiden
  • estrogen
  • fibrinolytic agent
  • fondaparinux
  • heparin
  • low molecular weight heparin
  • prothrombin
  • rivaroxaban
  • blood clotting factor 5
  • adult
  • anticoagulant therapy
  • Article
  • bleeding
  • brain hemorrhage
  • deep vein thrombosis
  • estrogen therapy
  • female
  • gastrointestinal hemorrhage
  • gene mutation
  • hazard ratio
  • hematoma
  • hematuria
  • homozygosity
  • human
  • immobility
  • lung embolism
  • major clinical study
  • male
  • malignant neoplasm
  • menorrhagia
  • metastasis
  • pregnancy
  • priority journal
  • recurrent disease
  • retroperitoneal hemorrhage
  • thrombophilia
  • treatment duration
  • vena cava filter
  • venous thromboembolism
  • activated protein C resistance
  • chemically induced
  • complication
  • genetics
  • Hemorrhage
  • heterozygote
  • middle aged
  • mutation
  • risk factor
  • treatment outcome
  • Activated Protein C Resistance
  • Anticoagulants
  • Factor V
  • Female
  • Heterozygote
  • Humans
  • Male
  • Middle Aged
  • Mutation
  • Prothrombin
  • Risk Factors
  • Treatment Outcome
  • Venous Thromboembolism


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