Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: Multinational prospective cohort management study

BMJ (Online)

Volumn 356, Issue , 2017, Pages

  Rodger, Marc A ^a,b   Le Gal, Gregoire ^a,b,c   Anderson, David R ^d   Schmidt, Jeannot ^e   Pernod, Gilles ^f   Kahn, Susan R ^g   Righini, Marc ^h   Mismetti, Patrick ⁱ   Kearon, Clive ^j   Meyer, Guy ^k   Elias, Antoine ^l   Ramsay, Tim ^a,b   Ortel, Thomas L ^m   Huisman, Menno V ⁿ   Kovacs, Michael J ^o  

^a UNIVERSITY OF OTTAWA   (Canada)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^c UNIVERSITÉ DE BRETAGNE OCCIDENTALE   (France)

^d DALHOUSIE UNIVERSITY   (Canada)

^e UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^f GRENOBLE UNIVERSITY HOSPITAL   (France)

^g MCGILL UNIVERSITY   (Canada)

^h GENEVA UNIVERSITY HOSPITALS   (Switzerland)

ⁱ UNIVERSITY HOSPITAL OF SAINT ETIENNE   (France)

^j MCMASTER UNIVERSITY   (Canada)

^k HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^l Centre Hospitalier Intercommunal Toulon La Seyne sur Mer   (France)

^m DUKE UNIVERSITY MEDICAL CENTER   (United States)

ⁿ LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^o UNIVERSITY OF WESTERN ONTARIO   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; D DIMER;

ADULT; ARTICLE; BLEEDING; BLOOD LEVEL; BODY MASS; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DISEASE ASSESSMENT; DISEASE CLASSIFICATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HERDOO2 CRITERIA; HIGH RISK PATIENT; HUMAN; LEG THROMBOSIS; LOW RISK PATIENT; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OBESITY; OUTCOME ASSESSMENT; PROSPECTIVE STUDY; RECURRENT DISEASE; RISK ASSESSMENT; RISK FACTOR; SHORT COURSE THERAPY; TREATMENT DURATION; VALIDATION PROCESS; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM; CLINICAL DECISION MAKING; CLINICAL TRIAL; DECISION SUPPORT SYSTEM; MIDDLE AGED; TREATMENT OUTCOME; VENOUS THROMBOSIS;

ANTICOAGULANTS; CLINICAL DECISION-MAKING; DECISION SUPPORT TECHNIQUES; FEMALE; FOLLOW-UP STUDIES; HUMANS; MIDDLE AGED; RISK FACTORS; TREATMENT OUTCOME; VENOUS THROMBOSIS;

EID: 85015779142     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.j1065     Document Type: Article

References (31)

1. Baglin T, Luddington R, Brown K, Baglin C. Incidence of recurrent venous thromboem bolism in relation to clinical, and thrombophilic risk factors: prospective cohort study. Lancet 2003;362:523-6. doi:10.1016/S0140-6736(03)14111-6
2. Kearon C, Akl EA, Comerota AJ, et al. American College of Chest Physicians. Antithrombotic therapy for VTE disease: Antithrombotic Therapy, and Prevention of Thrombosis, 9th ed. Chest 2012;141(Suppl):e419S-94S.
3. White RH. The epidemiology of venous thromboembolism. Circulation 2003;107(Suppl 1):I4-8. doi:10.1161/01.CIR.0000078468.11849.66
4. Agnelli G, Prandoni P, Santamaria MG, et al. Warfarin Optimal Duration Italian Trial Investigators. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. N Engl J Med 2001;345:165-9. doi:10.1056/NEJM200107193450302
5. Rodger MA, Scarvelis D, Kahn SR, et al. Long-Term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort. Thromb Res 2016;143:152-8. doi:10.1016/j. thromres.2016.03.028
6. Carrier M, Le Gal G, Wells PS, Rodger MA. Systematic review: case-fatality rates of recurrent venous thromboembolism, and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med 2010;152:578-89. doi:10.7326/0003-4819-152-9-201005040-00008
7. Castellucci LA, Cameron C, Le Gal G, et al. Efficacy, and safety outcomes of oral anticoagulants, and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review, and network meta-Analysis. BMJ 2013;347:f5133. doi:10.1136/bmj.f5133
8. Couturaud F, Sanchez O, Pernod G, et al. PADIS-PE Investigators. Six months vs extended oral anticoagulation after a first episode of pulmonary embolism: The PADIS-PE randomized clinical trial. JAMA 2015;314:31-40. doi:10.1001/jama.2015.7046
9. Agnelli G, Prandoni P, Becattini C, et al. Warfarin Optimal Duration Italian Trial Investigators. Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med 2003;139:19-25. doi:10.7326/0003-4819-139-1-200307010-00008
10. Pinede L, Ninet J, Duhaut P, et al. Investigators of the "Durée Optimale du Traitement AntiVitamines K" (DOTAVK) Study. Comparison of 3, and 6 months of oral anticoagulant therapy after a first episode of proximal deep vein thrombosis or pulmonary embolism, and comparison of 6, and 12 weeks of therapy after isolated calf deep vein thrombosis. Circulation 2001;103:2453-60. doi:10.1161/01.CIR.103.20.2453
11. Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease: CHEST Guideline, and Expert Panel Report. Chest 2016;149:315-52. doi:10.1016/j.chest.2015.11.026
12. Kearon C, Iorio A, Palareti G. Subcommittee on Control of Anticoagulation of the SSC of the ISTH. Risk of recurrent venous thromboembolism after stopping treatment in cohort studies: recommendation for acceptable rates, and standardized reporting. J Thromb Haemost 2010;8:2313-5. doi:10.1111/j.1538-7836.2010.03991.x.
13. Eichinger S, Heinze G, Jandeck LM, Kyrle PA. Risk assessment of recurrence in patients with unprovoked deep vein thrombosis or pulmonary embolism: the Vienna prediction model. Circulation 2010;121:1630-6. doi:10.1161/CIRCULATIONAHA.109.925214
14. Tosetto A, Iorio A, Marcucci M, et al. Predicting disease recurrence in patients with previous unprovoked venous thromboembolism: a proposed prediction score (DASH). J Thromb Haemost 2012;10:1019-25. doi:10.1111/j.1538-7836.2012.04735.x.
15. Rodger MA, Kahn SR, Wells PS, et al. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ 2008;179:417-26. doi:10.1503/cmaj.080493
16. Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C. Subcommittee on Control of Anticoagulation of the Scientific, and Standardization Committee of the International Society on Thrombosis, and Haemostasis. Definition of post-Thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost 2009;7:879-83.doi:10.1111/j.1538-7836.2009.03294.x.
17. McGinn TG, Guyatt GH, Wyer PC, Naylor CD, Stiell IG, Richardson WS. Evidence-Based Medicine Working Group. Users guides to the medical literature: XXII: how to use articles about clinical decision rules. JAMA 2000;284:79-84. doi:10.1001/jama.284.1.79
18. Douketis J, Tosetto A, Marcucci M, et al. Risk of recurrence after venous thromboembolism in men, and women: patient level meta-Analysis. BMJ 2011;342:d813. doi:10.1136/bmj.d813
19. Kyrle PA, Minar E, Bialonczyk C, Hirschl M, Weltermann A, Eichinger S. The risk of recurrent venous thromboembolism in men, and women. N Engl J Med 2004;350:2558-63. doi:10.1056/NEJMoa032959
20. Kearon C, Gent M, Hirsh J, et al. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med 1999;340:901-7. doi:10.1056/NEJM199903253401201
21. Stein PD, Henry JW, Gottschalk A. The addition of clinical assessment to stratification according to prior cardiopulmonary disease further optimizes the interpretation of ventilation/perfusion lung scans in pulmonary embolism. Chest 1993;104:1472-6. doi:10.1378/chest.104.5.1472
22. Wells PS, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med 2003;349:1227-35. doi:10.1056/NEJMoa023153
23. Schulman S, Kearon C. Subcommittee on Control of Anticoagulation of the Scientific, and Standardization Committee of the International Society on Thrombosis, and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005;3:692-4. doi:10.1111/j.1538-7836.2005.01204.x.
24. Kearon C. Indefinite anticoagulation after a first episode of unprovoked venous thromboembolism: yes. J Thromb Haemost 2007;5:2330-5. doi:10.1111/j.1538-7836.2007.02761.x.
25. Konstantinides SV, Torbicki A, Agnelli G, et al. Task Force for the Diagnosis, and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis, and management of acute pulmonary embolism. Eur Heart J 2014;35:3033-69. doi:10.1093/eurheartj/ehu283
26. Verhovsek M, Douketis JD, Yi Q, et al. Systematic review: D-dimer to predict recurrent disease after stopping anticoagulant therapy for unprovoked venous thromboembolism. Ann Intern Med 2008;149:481-90, W94
27. Carrier M, Rodger MA, Wells PS, Righini M, LE Gal G. Residual vein obstruction to predict the risk of recurrent venous thromboembolism in patients with deep vein thrombosis: a systematic review, and meta-Analysis. J Thromb Haemost 2011;9:1119-25. doi:10.1111/j.1538-7836.2011.04254.x.
28. Donadini MP, Ageno W, Antonucci E, et al. Prognostic significance of residual venous obstruction in patients with treated unprovoked deep vein thrombosis: a patient-level meta-Analysis. Thromb Haemost 2014;111:172-9. doi:10.1160/TH13-04-0336
29. Gauthier K, Le Gal G, Shivakumar S, et al. Inter-observer reliability of the HERDOO2 clinical decision rule. Thromb Res 2016;141:136-8. doi:10.1016/j.thromres.2016.03.015
30. Le Gal G, Kovacs MJ, Carrier M, et al. Risk of recurrent venous thromboembolism after a first oestrogen-Associated episode. Data from the REVERSE cohort study. Thromb Haemost 2010;104:498-503. doi:10.1160/TH09-10-0685
31. Le Moigne E, Delluc A, Tromeur C, et all. Risk of recurrent venous thromboembolism among young women after a first event while exposed to combined oral contraception versus not exposed to: A cohort study. Thromb Res 2013:132-51