Key result
Factor V Leiden was not associated with a higher risk of recurrent VTE within two years after discontinuation of oral anticoagulants compared to patients without the mutation (10.6% vs 12.4%).
Why the study?
Does the presence of Factor V Leiden mutation increase the risk of recurrent VTE in patients after discontinuation of oral anticoagulants?
Cohort (n=380)
Yes
Does the presence of Factor V Leiden mutation increase the risk of recurrent VTE in patients after discontinuation of oral anticoagulants?
Absolute Event Rate: 10.6% vs 12.4%
p-value: p=not significant
Patients with Factor V Leiden are not at a higher risk of recurrent VTE within two years after discontinuing oral anticoagulants compared to those without the mutation, suggesting they may not benefit from extended anticoagulation.
No increased recurrence with factor V Leiden after stopping anticoagulation; challenges extended therapy rationale but leaves open need for randomized confirmation.
Thromboprophylaxis with oral anticoagulants up to six months is established in patients after a first venous thromboembolic event (VTE). The risk of recurrent VTE is still considerable thereafter, and it is uncertain whether some patients might benefit from extended anti-coagulation. We performed a prospective, multicenter trial (4 thrombosis centers) and evaluated in 380 patients with a first or recurrent VTE (patients with a deficiency of antithrombin, protein C, protein S or plasminogen; cancer; or an antiphospholipid antibody syndrome were excluded) the risk of recurrence after discontinuation of secondary thromboprophylaxis with oral anticoagulants. It was the aim of the study to evaluate whether patients, with factor V Leiden are at an increased risk of recurrent VTE. 112 (29.5%) patients were carriers of factor V Leiden (26.9% heterozygous, 2.6% homozygous). After a median observation time of 19.3 months the overall recurrence rate of VTE was 9.9%. Recurrent deep vein thrombosis and/or pulmonary embolism occurred in 26 of 268 patients without factor V Leiden (9.7%) and in 10 of 112 patients with factor V Leiden (8.9%). The probability of recurrent VTE two years after discontinuation of oral anticoagulants was 12.4% (95% CI 7.8-17) in patients without factor V Leiden and was 10.6% (95% CI 3.8-17.4) in carriers of the mutation. This difference was statistically not significant. Patients with factor V Leiden are not at a higher risk of recurrent VTE within two years after discontinuation of oral anticoagulants than patients without factor V Leiden. Balancing the risk of recurrent VTE and bleeding from oral anticoagulants, patients with factor V Leiden are not likely to benefit from oral anticoagulant therapy extended beyond six months.
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Eichinger et al. (1997) conducted a cohort in First or recurrent venous thromboembolism (VTE) (n=380). Factor V Leiden mutation vs. No Factor V Leiden mutation was evaluated on Recurrent VTE two years after discontinuation of oral anticoagulants (p=not significant). Factor V Leiden was not associated with a higher risk of recurrent VTE within two years after discontinuation of oral anticoagulants compared to patients without the mutation (10.6% vs 12.4%).
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