Thromb Haemost 1997; 77(04): 624-628
DOI: 10.1055/s-0038-1656023
Clinical Studies
Schattauer GmbH Stuttgart

The Risk of Recurrent Venous Thromboembolism in Patients with and without Factor V Leiden

Sabine Eichinger
1   The Department of Internal Medicine I, Division of Hematology and Hemostaseology, University of Vienna, Austria
,
Ingrid Pabinger
1   The Department of Internal Medicine I, Division of Hematology and Hemostaseology, University of Vienna, Austria
,
Andreas Stümpfien
2   Department of Internal Medicine II, Division of Angiology, University of Vienna, Austria
,
Mirko Hirschl
3   Department of Hanuschkrankenhaus, Vienna
,
Christine Bialonczyk
4   Department of Wilhelminenspital, Vienna
,
Barbara Schneider
5   Department of Medical Statistics, University of Vienna, Austria
,
Christine Mannhalter
6   Department of Laboratory Medicine, University of Vienna, Austria
,
Erich Minar
2   Department of Internal Medicine II, Division of Angiology, University of Vienna, Austria
,
Klaus Lechner
1   The Department of Internal Medicine I, Division of Hematology and Hemostaseology, University of Vienna, Austria
,
Paul A Kyrle
1   The Department of Internal Medicine I, Division of Hematology and Hemostaseology, University of Vienna, Austria
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Publikationsverlauf

Received 12. November 1996

Accepted after revision 11. Dezember 1996

Publikationsdatum:
11. Juli 2018 (online)

Summary

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 anticoagulation. 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% Cl 7.8-17) in patients without factor V Leiden and was 10.6% (95% Cl 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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