A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism

Clive Kearon, Michael Gent, Jack Hirsh, Jeffrey Weitz, Michael J. Kovacs, David R. Anderson, Alexander G. Turpie, David Green, Jeffrey S. Ginsberg, Philip Wells, Betsy Mackinnon, Jim A. Julian

Producción científica: Contribución a una revistaArtículorevisión exhaustiva

1099 Citas (Scopus)

Resumen

Background: Patients who have a first episode of venous thromboembolism in the absence of known risk factors for thrombosis (idiopathic thrombosis) are often treated with anticoagulant therapy for three months. Such patients may benefit from longer treatment, however, because they appear to have an increased risk of recurrence after anticoagulant therapy is stopped. Methods: In this double-blind study, we randomly assigned patients who had completed 3 months of anticoagulant therapy for a first episode of idiopathic venous thromboembolism to continue receiving warfarin, with the dose adjusted to achieve an international normalized ratio of 2.0 to 3.0, or to receive placebo for a further 24 months. Our goal was to determine the effects of extended anticoagulant therapy on rates of recurrent symptomatic venous thromboembolism and bleeding. Results: A prespecified interim analysis of efficacy led to the early termination of the trial after 162 patients had been enrolled and followed for an average of 10 months. Of 83 patients assigned to continue to receive placebo, 17 had a recurrent episode of venous thromboembolism (27.4 percent per patient-year), as compared with 1 of 79 patients assigned to receive warfarin (1.3 percent per patient-year, P<0.001). Warfarin resulted in a 95 percent reduction in the risk of recurrent venous thromboembolism (95 percent confidence interval, 63 to 99 percent). Three patients assigned to the warfarin group had nonfatal major bleeding (two had gastrointestinal bleeding and one genitourinary bleeding), as compared with none of those assigned to the placebo group (3.8 percent vs. 0 percent per patient-year, P=0.09). Conclusions: Patients with a first episode of idiopathic venous thromboembolism should be treated with anticoagulant agents for longer than three months.

Idioma originalEnglish
Páginas (desde-hasta)901-907
Número de páginas7
PublicaciónNew England Journal of Medicine
Volumen340
N.º12
DOI
EstadoPublished - mar. 25 1999

ASJC Scopus Subject Areas

  • General Medicine

PubMed: MeSH publication types

  • Clinical Trial
  • Comparative Study
  • Journal Article
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

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