Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort

Marc A. Rodger; Dimitri Scarvelis; Susan R. Kahn; Philip S. Wells; David A. Anderson; Isabelle Chagnon; Grégoire Le Gal; Esteban Gandara; Susan Solymoss; Elham Sabri; Judy Kovacs; Michael J. Kovacs

doi:10.1016/j.thromres.2016.03.028

Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort

Marc A. Rodger, Dimitri Scarvelis, Susan R. Kahn, Philip S. Wells, David A. Anderson, Isabelle Chagnon, Grégoire Le Gal, Esteban Gandara, Susan Solymoss, Elham Sabri, Judy Kovacs, Michael J. Kovacs

Medicine

Producción científica: Contribución a una revista › Artículo › revisión exhaustiva

35 Citas (Scopus)

Resumen

Background Choosing short-term (3-6 months) or indefinite anticoagulation after a first unprovoked venous thromboembolic event (VTE) is a common and difficult clinical decision. The long-term absolute risk of recurrent VTE after a first unprovoked VTE, in all patients and sub-groups, is not well established, hindering decision making. Methods We conducted a multi-center multi-national prospective cohort study in first unprovoked VTE patients to establish the long-term risk of recurrent VTE after short-term anticoagulation in first unprovoked VTE patients (and sub-groups).We followed patients for symptomatic suspected VTE off of OAT. Suspected recurrent VTE was investigated with reference to baseline imaging and then independently and blindly adjudicated. Findings We recruited 663 participants between October, 2001 and March 2006 with the last follow-up in April 2014. During a mean 5.0 years of follow-up, 165/663 suspected VTE (in 408 patients) were adjudicated as recurrent VTE resulting in an annualized risk of recurrent VTE of 5.0% (95% CI: 4.2-5.8%) with a cumulative risk of 29.6% at 8 years. Men had a 7.6% (95% CI: 6.3-9.2%) annual risk of recurrent VTE. High risk women (2 or more HERDOO2 points; see text) had an annual risk of recurrent VTE of 5.9% (95% CI: 4.2-8.1%). Low risk women (1 or 0 HERDOO2 points) had 1.1% (95% CI: 0.6-2.0%) annual risk of recurrent VTE with a cumulative risk of 8.7% at 8 years. Interpretation Men and high risk women with unprovoked VTE should be considered for long-term anticoagulant therapy given a high risk of recurrent VTE after long-term follow-up. Women with a low HERDOO2 score may be able to safely discontinue anticoagulants. Funding This study was funded by the Canadian Institutes of Health Research (Grant # MOP 64319) and Heart and Stroke Foundation of Ontario (Grant # NA 6771). Registered at www.clinicaltrials.gov identifier: NCT00261014

Idioma original	English
Páginas (desde-hasta)	152-158
Número de páginas	7
Publicación	Thrombosis Research
Volumen	143
DOI	https://doi.org/10.1016/j.thromres.2016.03.028
Estado	Published - feb. 18 2016

Nota bibliográfica

Funding Information:
This study was funded by the Canadian Institutes of Health Research (Grant # MOP 64319) and Heart and Stroke Foundation of Ontario (Grant # NA 6771). Dr. Rodger had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All analyses were conducted by Dr. Rodger and Ms. Elham Sabri from the Ottawa Hospital Research Institute independent of the funders.

Funding Information:
Dr. Rodger is a Career Investigator Award from the Heart and Stroke Foundation of Canada and holds the University of Ottawa Faculty of Medicine Clinical Research Chair in Thrombosis and Thrombophilia. Drs. Kahn is a Tier 1 Canada Research Chairholder. We thank the staff and patients from the Thrombosis clinics who participated in the study. The results reported in this paper were presented in part at the International Society of Thrombosis and Hemostasis meeting in June 2015 in Toronto, Canada. Appendix I We collected the following information at the time of enrollment: 1) Demographic variables: age, gender, ethnic background (participant’s selection of ethnicity) given variable rates of thrombophilia in different ethnicities, socioeconomic status, height, weight and BMI, 2) Risk factors for index VTE: immobilization, surgery, low extremity fracture, stroke, myocardial infarction, hormone replacement, oral contraceptive use, malignancy, varicose veins, trauma, pregnancy or 6 weeks postpartum, family history of VTE, previous secondary VTE, known thrombophilias (Protein C, S or AT deficiency, antiphospholipid antibody syndrome, hyperhomocysteinemia, Factor V Leiden and Prothrombin gene mutation), statin use, known hypercholesterolemia, 3) Concomitant medications, 4) Compression stocking use, 5) Laboratory data: Factor V Leiden, Prothrombin Gene Mutation, Hemoglobin, Platelets, C-reactive protein, Homocysteine, Factor VIII, D-Dimer, Lupus anticoagulant, Anticardiolipin IgG, Anticardiolipin IgM, INR and aPTT, 6) Imaging: Ventilation Perfusion Scan (V/Q) (residual PE was classified as ‘yes or no’ and the pulmonary vascular obstruction (PVO) score was calculated [23] and compression ultrasound of legs with symptoms or signs of DVT at the time of index event (residual DVT was classified as ‘yes or no’ as per Prandoni criteria [21] and ‘percentage obstruction’ as per Piovella criteria [22] and 7) Post-thrombotic syndrome: Symptoms in either leg of cramps, itching, pins and needles, pain or swelling and signs in either leg of pretibial edema, skin induration, hyperpigmentation, venous ectasia, redness, pain during calf compression, warmth, dependent cyanosis or leg ulcers and leg circumference.

Publisher Copyright:
© 2016 The Authors

ASJC Scopus Subject Areas

Hematology

PubMed: MeSH publication types

Clinical Trial
Journal Article
Multicenter Study

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10.1016/j.thromres.2016.03.028

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Rodger, M. A., Scarvelis, D., Kahn, S. R., Wells, P. S., Anderson, D. A., Chagnon, I., Le Gal, G., Gandara, E., Solymoss, S., Sabri, E., Kovacs, J., & Kovacs, M. J. (2016). Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort. Thrombosis Research, 143, 152-158. https://doi.org/10.1016/j.thromres.2016.03.028

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abstract = "Background Choosing short-term (3-6 months) or indefinite anticoagulation after a first unprovoked venous thromboembolic event (VTE) is a common and difficult clinical decision. The long-term absolute risk of recurrent VTE after a first unprovoked VTE, in all patients and sub-groups, is not well established, hindering decision making. Methods We conducted a multi-center multi-national prospective cohort study in first unprovoked VTE patients to establish the long-term risk of recurrent VTE after short-term anticoagulation in first unprovoked VTE patients (and sub-groups).We followed patients for symptomatic suspected VTE off of OAT. Suspected recurrent VTE was investigated with reference to baseline imaging and then independently and blindly adjudicated. Findings We recruited 663 participants between October, 2001 and March 2006 with the last follow-up in April 2014. During a mean 5.0 years of follow-up, 165/663 suspected VTE (in 408 patients) were adjudicated as recurrent VTE resulting in an annualized risk of recurrent VTE of 5.0% (95% CI: 4.2-5.8%) with a cumulative risk of 29.6% at 8 years. Men had a 7.6% (95% CI: 6.3-9.2%) annual risk of recurrent VTE. High risk women (2 or more HERDOO2 points; see text) had an annual risk of recurrent VTE of 5.9% (95% CI: 4.2-8.1%). Low risk women (1 or 0 HERDOO2 points) had 1.1% (95% CI: 0.6-2.0%) annual risk of recurrent VTE with a cumulative risk of 8.7% at 8 years. Interpretation Men and high risk women with unprovoked VTE should be considered for long-term anticoagulant therapy given a high risk of recurrent VTE after long-term follow-up. Women with a low HERDOO2 score may be able to safely discontinue anticoagulants. Funding This study was funded by the Canadian Institutes of Health Research (Grant # MOP 64319) and Heart and Stroke Foundation of Ontario (Grant # NA 6771). Registered at www.clinicaltrials.gov identifier: NCT00261014",

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year = "2016",

month = feb,

day = "18",

doi = "10.1016/j.thromres.2016.03.028",

language = "English",

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T1 - Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event

T2 - A multi-national cohort

AU - Rodger, Marc A.

AU - Scarvelis, Dimitri

AU - Kahn, Susan R.

AU - Wells, Philip S.

AU - Anderson, David A.

AU - Chagnon, Isabelle

AU - Le Gal, Grégoire

AU - Gandara, Esteban

AU - Solymoss, Susan

AU - Sabri, Elham

AU - Kovacs, Judy

AU - Kovacs, Michael J.

N1 - Funding Information: This study was funded by the Canadian Institutes of Health Research (Grant # MOP 64319) and Heart and Stroke Foundation of Ontario (Grant # NA 6771). Dr. Rodger had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All analyses were conducted by Dr. Rodger and Ms. Elham Sabri from the Ottawa Hospital Research Institute independent of the funders. Funding Information: Dr. Rodger is a Career Investigator Award from the Heart and Stroke Foundation of Canada and holds the University of Ottawa Faculty of Medicine Clinical Research Chair in Thrombosis and Thrombophilia. Drs. Kahn is a Tier 1 Canada Research Chairholder. We thank the staff and patients from the Thrombosis clinics who participated in the study. The results reported in this paper were presented in part at the International Society of Thrombosis and Hemostasis meeting in June 2015 in Toronto, Canada. Appendix I We collected the following information at the time of enrollment: 1) Demographic variables: age, gender, ethnic background (participant’s selection of ethnicity) given variable rates of thrombophilia in different ethnicities, socioeconomic status, height, weight and BMI, 2) Risk factors for index VTE: immobilization, surgery, low extremity fracture, stroke, myocardial infarction, hormone replacement, oral contraceptive use, malignancy, varicose veins, trauma, pregnancy or 6 weeks postpartum, family history of VTE, previous secondary VTE, known thrombophilias (Protein C, S or AT deficiency, antiphospholipid antibody syndrome, hyperhomocysteinemia, Factor V Leiden and Prothrombin gene mutation), statin use, known hypercholesterolemia, 3) Concomitant medications, 4) Compression stocking use, 5) Laboratory data: Factor V Leiden, Prothrombin Gene Mutation, Hemoglobin, Platelets, C-reactive protein, Homocysteine, Factor VIII, D-Dimer, Lupus anticoagulant, Anticardiolipin IgG, Anticardiolipin IgM, INR and aPTT, 6) Imaging: Ventilation Perfusion Scan (V/Q) (residual PE was classified as ‘yes or no’ and the pulmonary vascular obstruction (PVO) score was calculated [23] and compression ultrasound of legs with symptoms or signs of DVT at the time of index event (residual DVT was classified as ‘yes or no’ as per Prandoni criteria [21] and ‘percentage obstruction’ as per Piovella criteria [22] and 7) Post-thrombotic syndrome: Symptoms in either leg of cramps, itching, pins and needles, pain or swelling and signs in either leg of pretibial edema, skin induration, hyperpigmentation, venous ectasia, redness, pain during calf compression, warmth, dependent cyanosis or leg ulcers and leg circumference. Publisher Copyright: © 2016 The Authors

PY - 2016/2/18

Y1 - 2016/2/18

N2 - Background Choosing short-term (3-6 months) or indefinite anticoagulation after a first unprovoked venous thromboembolic event (VTE) is a common and difficult clinical decision. The long-term absolute risk of recurrent VTE after a first unprovoked VTE, in all patients and sub-groups, is not well established, hindering decision making. Methods We conducted a multi-center multi-national prospective cohort study in first unprovoked VTE patients to establish the long-term risk of recurrent VTE after short-term anticoagulation in first unprovoked VTE patients (and sub-groups).We followed patients for symptomatic suspected VTE off of OAT. Suspected recurrent VTE was investigated with reference to baseline imaging and then independently and blindly adjudicated. Findings We recruited 663 participants between October, 2001 and March 2006 with the last follow-up in April 2014. During a mean 5.0 years of follow-up, 165/663 suspected VTE (in 408 patients) were adjudicated as recurrent VTE resulting in an annualized risk of recurrent VTE of 5.0% (95% CI: 4.2-5.8%) with a cumulative risk of 29.6% at 8 years. Men had a 7.6% (95% CI: 6.3-9.2%) annual risk of recurrent VTE. High risk women (2 or more HERDOO2 points; see text) had an annual risk of recurrent VTE of 5.9% (95% CI: 4.2-8.1%). Low risk women (1 or 0 HERDOO2 points) had 1.1% (95% CI: 0.6-2.0%) annual risk of recurrent VTE with a cumulative risk of 8.7% at 8 years. Interpretation Men and high risk women with unprovoked VTE should be considered for long-term anticoagulant therapy given a high risk of recurrent VTE after long-term follow-up. Women with a low HERDOO2 score may be able to safely discontinue anticoagulants. Funding This study was funded by the Canadian Institutes of Health Research (Grant # MOP 64319) and Heart and Stroke Foundation of Ontario (Grant # NA 6771). Registered at www.clinicaltrials.gov identifier: NCT00261014

AB - Background Choosing short-term (3-6 months) or indefinite anticoagulation after a first unprovoked venous thromboembolic event (VTE) is a common and difficult clinical decision. The long-term absolute risk of recurrent VTE after a first unprovoked VTE, in all patients and sub-groups, is not well established, hindering decision making. Methods We conducted a multi-center multi-national prospective cohort study in first unprovoked VTE patients to establish the long-term risk of recurrent VTE after short-term anticoagulation in first unprovoked VTE patients (and sub-groups).We followed patients for symptomatic suspected VTE off of OAT. Suspected recurrent VTE was investigated with reference to baseline imaging and then independently and blindly adjudicated. Findings We recruited 663 participants between October, 2001 and March 2006 with the last follow-up in April 2014. During a mean 5.0 years of follow-up, 165/663 suspected VTE (in 408 patients) were adjudicated as recurrent VTE resulting in an annualized risk of recurrent VTE of 5.0% (95% CI: 4.2-5.8%) with a cumulative risk of 29.6% at 8 years. Men had a 7.6% (95% CI: 6.3-9.2%) annual risk of recurrent VTE. High risk women (2 or more HERDOO2 points; see text) had an annual risk of recurrent VTE of 5.9% (95% CI: 4.2-8.1%). Low risk women (1 or 0 HERDOO2 points) had 1.1% (95% CI: 0.6-2.0%) annual risk of recurrent VTE with a cumulative risk of 8.7% at 8 years. Interpretation Men and high risk women with unprovoked VTE should be considered for long-term anticoagulant therapy given a high risk of recurrent VTE after long-term follow-up. Women with a low HERDOO2 score may be able to safely discontinue anticoagulants. Funding This study was funded by the Canadian Institutes of Health Research (Grant # MOP 64319) and Heart and Stroke Foundation of Ontario (Grant # NA 6771). Registered at www.clinicaltrials.gov identifier: NCT00261014

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ER -

Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort

Resumen

Nota bibliográfica

ASJC Scopus Subject Areas

PubMed: MeSH publication types

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