Decision analysis model of prolonged oral anticoagulant treatment in factor V Leiden carriers with first episode of deep vein thrombosis

BMJ 1998;316:95-99 (10 January)

Papers

Decision analysis model of prolonged oral anticoagulant treatment in factor V Leiden carriers with first episode of deep vein thrombosis

François P Sarasin, senior registrar,department of internal medicine,^a Henri Bounameaux, head, division of angiology and haemostasis ^a

^a Medical Clinics and the Division of Angiology and Haemostasis, Department of Internal Medicine, Hospital Cantonal, University of Geneva Medical School, Geneva, Switzerland

Correspondence to: Dr F PSarasin Department of Internal Medicine, Hospital Cantonal, 24 rue Micheli du Crest, 1211 Geneva 14, Switzerland sarasin-francois@diogenes.hcuge.ch

Objective: To assess the risks and benefits of oral anticoagulanttreatment extended beyond 3 months after a first episode ofdeep vein thrombosis in patients who carry factor V Leiden mutation.Such patients have over twice the risk of recurrence after therecommended treatment period, but more information is requiredbefore widespread genetic screening can be recommended.
Design: A decision analysis Markov model (with data extractedform literature) representing the risks of developing symptomaticvenous thromboembolism, the risks of major bleeding, and theefficacy of anticoagulant treatment.
Subjects: A hypothetical cohort of 1000 carriers of factor VLeiden recovering from a first episode of deep vein thrombosisin the lower limbs.
Main outcome measures: Risks and benefits of, firstly, stoppingoral anticoagulation 3 months after first episode of thrombosiswith reinitiation of treatment only after recurrent thrombosisand, secondly, extension of oral anticoagulation up to 1 to5 years.
Results: Despite consistent biases in favour of extended oralanticoagulation, analysis revealed that among factor V carriersthe number of major haemorrhages induced by oral anticoagulantswould exceed that of clinical pulmonary emboli prevented overthe entire range of duration of anticoagulation (1 to 5 years).On the other hand, the number of recurrent deep vein thrombiprevented would exceed that of iatrogenic major bleedings.
Conclusion: The lack of evidence of a net clinical benefit ofprolonged oral anticoagulation, at least beyond 1 year, amongpatients recovering from acute deep vein thrombosis does notsupport the decision to promote widespread genetic screeningprogrammes to detect the factor V mutation.

Key messages

Patients who carry the factor V Leiden mutation have a more than twice the risk of recurrence after a first episode of deep vein thrombosis
Before screening for the abnormality is advocated in all patients recovering from acute deep vein thrombosis, it should be determined whether carriers of the mutation would benefit from the diagnosis
The risks (major haemorrhage) of extended oral anticoagulation beyond the usually recommended 3 month period would exceed its benefits, in terms of clinical pulmonary emboli prevented
The decision to promote widespread screening programmes to detect factor V mutation should be questioned in the absence of clinical benefit provided by extended use of oral anticoagulants

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Relevant Article

Anticoagulation may be beneficial in high risk factor V Leiden carriers: Trevor Baglin, Caroline Baglin, Karen Brown, Roger Luddington, and East Anglian Thrombophilia Study Group
BMJ 1998 317: 416. [Extract] [Full Text]

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