Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy

Marc A. Rodger, Susan R. Kahn, Philip S. Wells, David A. Anderson, Isabelle Chagnon, Grégoire Le Gal, Susan Solymoss, Mark Crowther, Arnaud Perrier, Richard H White, Linda Vickars, Tim Ramsay, Marisol T. Betancourt, Michael J. Kovacs

Research output: Contribution to journalArticle

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Abstract

Background: Whether to continue oral anticoagulant therapy beyond 6 months after an "unprovoked" venous thromboembolism is controversial. We sought to determine clinical predictors to identify patients who are at low risk of recurrent venous thromboembolism who could safely discontinue oral anticoagulants. Methods: In a multicentre prospective cohort study, 646 participants with a first, unprovoked major venous thromboembolism were enrolled over a 4-year period. Of these, 600 participants completed a mean 18-month follow-up in September 2006. We collected data for 69 potential predictors of recurrent venous thromboembolism while patients were taking oral anticoagulation therapy (5-7 months after initiation). During follow-up after discontinuing oral anticoagulation therapy, all episodes of suspected recurrent venous thromboembolism were independently adjudicated. We performed a multivariable analysis of predictor variables (p < 0.10) with high interobserver reliability to derive a clinical decision rule. Results: We identified 91 confirmed episodes of recurrent venous thromboembolism during follow-up after discontinuing oral anticoagulation therapy (annual risk 9.3%, 95% CI 7.7%-11.3%). Men had a 13.7% (95% CI 10.8%-17.0%) annual risk. There was no combination of clinical predictors that satisfied our criteria for identifying a low-risk subgroup of men. Fifty-two percent of women had 0 or 1 of the following characteristics: hyperpigmentation, edema or redness of either leg; D-dimer ≥ 250 μg/L while taking warfarin; body mass index ≥ 30 kg/m2; or age ≥ 65 years. These women had an annual risk of 1.6% (95% CI 0.3%-4.6%). Women who had 2 or more of these findings had an annual risk of 14.1% (95% CI 10.9%-17.3%). Interpretation: Women with 0 or 1 risk factor may safely discontinue oral anticoagulant therapy after 6 months of therapy following a first unprovoked venous thromboembolism. This criterion does not apply to men. (http://Clinicaltrials.gov trial register number NCT00261014).

Original languageEnglish (US)
Pages (from-to)417-426
Number of pages10
JournalCMAJ
Volume179
Issue number5
DOIs
StatePublished - Aug 26 2008

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Thromboembolism
Venous Thromboembolism
Anticoagulants
Recurrence
Therapeutics
Hyperpigmentation
Warfarin
Edema
Leg
Body Mass Index
Cohort Studies
Prospective Studies

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Rodger, M. A., Kahn, S. R., Wells, P. S., Anderson, D. A., Chagnon, I., Le Gal, G., ... Kovacs, M. J. (2008). Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ, 179(5), 417-426. https://doi.org/10.1503/cmaj.080493

Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. / Rodger, Marc A.; Kahn, Susan R.; Wells, Philip S.; Anderson, David A.; Chagnon, Isabelle; Le Gal, Grégoire; Solymoss, Susan; Crowther, Mark; Perrier, Arnaud; White, Richard H; Vickars, Linda; Ramsay, Tim; Betancourt, Marisol T.; Kovacs, Michael J.

In: CMAJ, Vol. 179, No. 5, 26.08.2008, p. 417-426.

Research output: Contribution to journalArticle

Rodger, MA, Kahn, SR, Wells, PS, Anderson, DA, Chagnon, I, Le Gal, G, Solymoss, S, Crowther, M, Perrier, A, White, RH, Vickars, L, Ramsay, T, Betancourt, MT & Kovacs, MJ 2008, 'Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy', CMAJ, vol. 179, no. 5, pp. 417-426. https://doi.org/10.1503/cmaj.080493
Rodger, Marc A. ; Kahn, Susan R. ; Wells, Philip S. ; Anderson, David A. ; Chagnon, Isabelle ; Le Gal, Grégoire ; Solymoss, Susan ; Crowther, Mark ; Perrier, Arnaud ; White, Richard H ; Vickars, Linda ; Ramsay, Tim ; Betancourt, Marisol T. ; Kovacs, Michael J. / Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. In: CMAJ. 2008 ; Vol. 179, No. 5. pp. 417-426.
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AU - Chagnon, Isabelle

AU - Le Gal, Grégoire

AU - Solymoss, Susan

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N2 - Background: Whether to continue oral anticoagulant therapy beyond 6 months after an "unprovoked" venous thromboembolism is controversial. We sought to determine clinical predictors to identify patients who are at low risk of recurrent venous thromboembolism who could safely discontinue oral anticoagulants. Methods: In a multicentre prospective cohort study, 646 participants with a first, unprovoked major venous thromboembolism were enrolled over a 4-year period. Of these, 600 participants completed a mean 18-month follow-up in September 2006. We collected data for 69 potential predictors of recurrent venous thromboembolism while patients were taking oral anticoagulation therapy (5-7 months after initiation). During follow-up after discontinuing oral anticoagulation therapy, all episodes of suspected recurrent venous thromboembolism were independently adjudicated. We performed a multivariable analysis of predictor variables (p < 0.10) with high interobserver reliability to derive a clinical decision rule. Results: We identified 91 confirmed episodes of recurrent venous thromboembolism during follow-up after discontinuing oral anticoagulation therapy (annual risk 9.3%, 95% CI 7.7%-11.3%). Men had a 13.7% (95% CI 10.8%-17.0%) annual risk. There was no combination of clinical predictors that satisfied our criteria for identifying a low-risk subgroup of men. Fifty-two percent of women had 0 or 1 of the following characteristics: hyperpigmentation, edema or redness of either leg; D-dimer ≥ 250 μg/L while taking warfarin; body mass index ≥ 30 kg/m2; or age ≥ 65 years. These women had an annual risk of 1.6% (95% CI 0.3%-4.6%). Women who had 2 or more of these findings had an annual risk of 14.1% (95% CI 10.9%-17.3%). Interpretation: Women with 0 or 1 risk factor may safely discontinue oral anticoagulant therapy after 6 months of therapy following a first unprovoked venous thromboembolism. This criterion does not apply to men. (http://Clinicaltrials.gov trial register number NCT00261014).

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