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

Inna Tzoran, Manolis Papadakis, Benjamin Brenner, Ángeles Fidalgo, Agustina Rivas, Philip S. Wells, Olga Gavín, María Dolores Adarraga, Farès Moustafa, Manuel Monreal, Hervé Decousus, Paolo Prandoni, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Philip 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, P. García-Brotons, C. Gómez, V. Gómez, J. González, D. González-Marcano, E. Grau, A. Grimón, R. Guijarro, J. Gutiérrez, G. Hernández-Comes, L. Hernández-Blasco, M. J. Hermosa-Los Arcos, L. Jara-Palomares, M. J. Jaras, D. Jiménez, M. D. Joya, P. Llamas, R. Lecumberri, J. L. Lobo, P. López, L. López-Jiménez, R. López-Reyes, J. B. López-Sáez, M. A. Lorente, A. Lorenzo, A. Maestre, P. J. Marchena, F. Martín-Martos, J. A. Nieto, S. Nieto, A. Núñez, M. J. Núñez, M. Odriozola, R. Otero, J. M. Pedrajas, G. Pérez, C. Pérez-Ductor, M. L. Peris, J. A. Porras, O. Reig, A. Riera-Mestre, D. Riesco, C. Rodríguez, M. A. Rodríguez-Dávila, V. Rosa, N. Ruiz-Giménez, J. C. Sahuquillo, M. C. Sala-Sainz, A. Sampériz, R. Sánchez-Martínez, R. Sánchez Simón-Talero, O. Sanz, S. Soler, J. M. Suriñach, M. I. Torres, J. Trujillo-Santos, F. Uresandi, B. Valero, R. Valle, J. Vela, M. P. Vicente, A. Villalobos, T. Vanassche, P. Verhamme, J. Hirmerova, T. Tomko, G. del Pozo, E. Salgado, G. T. Sánchez, A. Bura-Riviere, I. Mahé, A. Merah, A. Braester, G. Antonucci, G. Barillari, F. Bilora, C. Bortoluzzi, C. Cattabiani, M. Ciammaichella, J. Di Biase, R. Duce, P. Ferrazzi, M. Giorgi-Pierfranceschi, E. Grandone, E. Imbalzano, C. Lodigiani, R. Maida, D. Mastroiacovo, F. Pace, R. Pesavento, M. Pinelli, R. Poggio, L. Rota, E. Tiraferri, D. Tonello, A. Tufano, A. Visonà, B. Zalunardo, V. Gibietis, A. Skride, B. Vitola, P. Monteiro, J. L. Ribeiro, M. S. Sousa, M. Zdraveska, L. Calanca, A. Erdmann, L. Mazzolai

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10 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)482.e1-482.e9
JournalAmerican Journal of Medicine
Volume130
Issue number4
DOIs
StatePublished - 1 Apr 2017

Bibliographical note

Publisher Copyright:
© 2017

Keywords

  • Anticoagulant therapy
  • Bleeding
  • Thrombophilia
  • Venous thromboembolism

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