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Determinants and Time Course of the Postthrombotic Syndrome after Acute Deep Venous Thrombosis

Susan R. Kahn, MD, MSc; Ian Shrier, MD, PhD; Jim A. Julian, MMath; Thierry Ducruet, MSc; Louise Arsenault, BA; Marie-José Miron, MD; Andre Roussin, MD; Sylvie Desmarais, MD; France Joyal, MD; Jeannine Kassis, MD; Susan Solymoss, MD; Louis Desjardins, MD; Donna L. Lamping, PhD; Mira Johri, PhD; and Jeffrey S. Ginsberg, MD
[+] Article and Author Information

Deceased.


From the Centre for Clinical Epidemiology and Community Studies and Jewish General Hospital, McGill University Health Centre and McGill University, and Centre Hospitalier de l'Université de Montréal and Université de Montréal, Montreal, Quebec, Canada; Henderson Research Centre and McMaster University Medical Center, McMaster University, Hamilton, Ontario, Canada; Centre Hospitalier Pierre-Boucher, Longueuil, Quebec, Canada; Université Laval, Quebec City, Quebec, Canada; and Health Services Research Unit, London School of Hygiene & Tropical Medicine, London, United Kingdom.


Acknowledgment: The authors thank the VETO (VEnous Thrombosis Outcomes) study personnel at the clinical study sites for their dedication to this project.

Grant Support: By the Fonds de la recherche en santé du Québec and by an unrestricted grant-in-aid from GlaxoSmithKline. Drs. Kahn and Shrier are recipients of Senior Clinical Investigator Awards from the Fonds de la recherche en santé du Québec. Dr. Johri received a New Investigator Award from the Canadian Institutes of Health Research. Dr. Ginsberg received a Career Award from the Heart and Stroke Foundation of Ontario and holds the David Braley and Nancy Gordon Chair in Thromboembolic Disease at McMaster University.

Potential Financial Conflicts of Interest: None disclosed.

Reproducible Research Statement:Study protocol, statistical code, and data set: Available to approved individuals through written agreements with the author by contacting Dr. Kahn (e-mail, susan.kahn@mcgill.ca.)

Requests for Single Reprints: Susan R. Kahn, MD, MSc, Centre for Clinical Epidemiology and Community Studies, Sir Mortimer B. Davis Jewish General Hospital, 3755 Cote Sainte Catherine, Room A-127, Montreal, Quebec H3T 1E2, Canada; e-mail, susan.kahn@mcgill.ca.

Current Author Addresses: Drs. Kahn and Shrier, Mr. Ducruet, and Ms. Arsenault: Centre for Clinical Epidemiology and Community Studies, Sir Mortimer B. Davis Jewish General Hospital, 3755 Côte Sainte- Catherine, Room A-127, Montreal, Quebec H3T 1E2, Canada.

Mr. Julian: Department of Oncology, Henderson Research Centre,McMaster University, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.

Drs. Miron, Roussin, and Joyal: Centre Hospitalier de l'Université de Montreal, Hôpital Notre-Dame, 1560 Rue Sherbrooke East, Montreal, Quebec H2L 4M1, Canada.

Dr. Desmarais: Centre Hospitalier Pierre Boucher, Jacques-Cartier Boulevard East, Longueuil, Quebec J4M 2A5, Canada.

Dr. Kassis: Hôpital Maisonneuve-Rosemont, 5415 De l'Assomption Boulevard, Montreal, Quebec H1T 2M4, Canada.

Dr. Solymoss: Division of Hematology, Montreal General Hospital, 1650 Cedar Avenue, Montreal, Quebec H3G 1A4, Canada.

Dr. Lamping: Health Services Research Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom.

Dr. Johri: University of Montreal, 1420 Mont-Royal Boulevard, Montreal, Quebec H2V 4P3, Canada.

Dr. Ginsberg: McMaster University, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada.

Author Contributions: Conception and design: S.R. Kahn, D.L. Lamping, M. Johri, J.S. Ginsberg.

Analysis and interpretation of the data: S.R. Kahn, I. Shrier, J.A. Julian, T. Ducruet.

Drafting of the article: S.R. Kahn, I. Shrier.

Critical revision of the article for important intellectual content: S.R. Kahn, I. Shrier, J.A. Julian, A. Roussin, F. Joyal, J. Kassis, S. Solymoss, D.L. Lamping, M. Johri, J.S. Ginsberg.

Final approval of the article: S.R. Kahn, I. Shrier, J.A. Julian, M.-J. Miron, A. Roussin, S. Desmarais, F. Joyal, J. Kassis, S. Solymoss, M. Johri, J.S. Ginsberg.

Provision of study materials or patients: S.R. Kahn, M.-J. Miron, A. Roussin, S. Desmarais, F. Joyal, J. Kassis, S. Solymoss, J.S. Ginsberg.

Statistical expertise: J.A. Julian, T. Ducruet.

Obtaining of funding: S.R. Kahn.

Administrative, technical, or logistic support: S.R. Kahn, L. Arsenault, M.-J. Miron, A. Roussin, F. Joyal, J. Kassis, D.L. Lamping.

Collection and assembly of data: S.R. Kahn, T. Ducruet, L. Arsenault, M.-J. Miron, A. Roussin, F. Joyal, S. Solymoss, J.S. Ginsberg.


Ann Intern Med. 2008;149(10):698-707. doi:10.7326/0003-4819-149-10-200811180-00004
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We found that the postthrombotic syndrome occurs in almost half of patients within 2 years after DVT, and about 3% of patients develop severe postthrombotic syndrome, including venous ulcers. We also found that postthrombotic symptoms and signs are not static but tend to fluctuate over time for many patients. Variables that predicted higher (worse) postthrombotic scores over time included greater severity of residual venous symptoms and signs 1 month after the diagnosis of DVT, thrombosis of the common femoral or iliac vein, previous ipsilateral venous thrombosis, higher BMI, older age, and female sex.

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Figures

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Figure 1.
Study flow diagram.

Numbers in boxes for follow-up intervals represent the number of patients who remained in the study and continued to be followed at a given interval, including patients who may have missed an earlier follow-up visit. DVT = deep venous thrombosis.

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Figure 2.
Movement of patients among postthrombotic severity categories during study follow-up.

The top panel represents study patients whose postthrombotic severity category was none (Villalta score, 0 to 4) or mild (Villalta score, 5 to 9) at the 1-month visit (n = 298); the bottom panel represents study patients whose postthrombotic severity category was moderate (Villalta score, 10 to 14) or severe (Villalta score >14 or ulcer present) at the 1-month visit (n = 49). Open circles represent patients with scores in the none or mild range and solid circles indicate patients with scores in the moderate or severe range for a given visit (indicated on x-axis). Green circles represent patients with missing data for that visit. Numbers in circles indicate the number of patients. Solid arrows signify movement from none–mild to moderate–severe postthrombotic severity category for the subsequent visit. Dotted arrows indicate movement from moderate–severe to none–mild category for the subsequent visit. Dashed green arrows represent movement from any category to missing for the subsequent visit. Data are shown for all study patients who had nonmissing 1-month Villalta scores (n = 347). Data for the 8-month visit are not shown.

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Figure 3.
Mean Villalta scores during study follow-up, stratified by 1-month postthrombotic severity category.

Data shown are actual means (squares and circles) at study follow-up visits (4, 8, 12, and 24 months) and model-predicted means (solid line) over continuous time, stratified by actual 1-month postthrombotic severity category (none: Villalta score, 0 to 4; mild: score, 5 to 9; moderate: score, 10 to 14; and severe: score >14 or ulcer present). Vertical bars around actual means represent 95% CIs. Open squares represent patients with mean Villalta score values categorized as severe at the 1-month visit. Solid squares represent patients with mean Villalta score values categorized as moderate at the 1-month visit. Open circles represent patients with mean Villalta score values categorized as mild at the 1-month visit. Solid circles represent patients with mean Villalta score values categorized as none at the 1-month visit. Model 2 (see Table 3) was used to generate model-predicted data.

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Figure 4.
Plots of individual patient Villalta score trajectories, stratified by 1-month postthrombotic severity category.

For each panel, the solid black line with bars represents the overall actual means of participants with complete data, and the error bars represent the SDs. The shaded line with “X” symbols on each panel represents the mean of the model-predicted values based on all 347 participants with 1-month score data, stratified by actual 1-month postthrombotic severity category. For clarity, the “X” symbol is slightly offset from the SD bars on the solid black line in each panel. A. Data shown represent a stratified random sample (n = 15) of participants with a postthrombotic severity category of none (score, 0 to 4) at 1-month follow-up (n = 3 for each score) who had complete data throughout follow-up (n = 124). B. Data shown represent a stratified random sample (n = 15) of participants with scores in the mild category (score, 5 to 9) at 1-month follow-up (n = 3 for each score) who had complete data throughout follow-up (n = 88). C. Data shown represent a random sample (n = 16) of participants with scores in the moderate category (score, 10 to 14) at 1-month follow-up who had complete data throughout follow-up (n = 22). D. Data shown represent all participants with scores in the severe category (score >14 or ulcer) at 1-month follow-up who had complete data throughout follow-up (n = 7).

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Appendix Figure.
Plots of Villalta score population averages of effects over time, by categorical predictor variables.

Plots show smoothed model-predicted Villalta scores over time for individual predictor variables (sex, previous ipsilateral deep venous thrombosis, extent of index deep venous thrombosis, age, body mass index, and Villalta severity category at 1 month). Model 2 (see Table 3) was used to generate model-predicted data. For all plots, the x-axis is follow-up time, and the y-axis is Villalta score (continuous). A. Model 2, smoothed predicted Villalta total score over time, by sex. B. Model 2, smoothed predicted Villalta total score over time, by previous ipsilateral deep venous thrombosis. C. Model 2, smoothed predicted Villalta total score over time, by extent of index deep venous thrombosis. D. Model 2, smoothed predicted Villalta total score over time, by age group. E. Model 2, smoothed predicted Villalta total score over time, by body mass index group. F. Model 2, smoothed predicted Villalta total score over time, by Villalta severity category at 1 month.

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