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Combined Effect of Factor V Leiden and Prothrombin 20210A on the Risk of Venous Thromboembolism - Pooled Analysis of 8 Case-control Studies Including 2310 Cases and 3204 Controls

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
Issue: 2001: 86/3 (Sept) pp.728-938
Pages: 809-816
Ahead of Print: ###MANUSCRIPT_aheadofprint###

Combined Effect of Factor V Leiden and Prothrombin 20210A on the Risk of Venous Thromboembolism - Pooled Analysis of 8 Case-control Studies Including 2310 Cases and 3204 Controls

Joseph Emmerich, Frits R. Rosendaal, Marco Cattaneo, Maurizio Margaglione, Valerio De Stefano, Tony Cumming, Valder Arruda, Andreas Hillarp, Jean-Luc Reny, for the study group for pooled-analysis in venous thromboembolism*
Paris: J. Emmerich, J. L. Reny, E. Arnaud, M. Alhenc-Gelas [Hôpital Européen Georges Pompidou, Service de Médecine Vasculaire (Centre Claude Bernard) et Laboratoire d’Hémostase, Paris, France]; Leiden: F. R. Rosendaal, T. Koster, J. P. Vandenbroucke, R.

Summary

Factor V Leiden and factor II G20210A mutations are two frequent genetic risk factors involved in venous thromboembolism (VTE). The goal of this pooled analysis of 8 case-control studies, comprising a total of 2310 cases and 3204 controls, was to precisely estimate the risk of VTE in patients bearing both mutations (double heterozygotes). Odds ratios for VTE were 4.9 (95% CI; 4.1-5.9) for the factor V Leiden and 3.8 (3.0-4.9) for the factor II G20210A mutation. Fifty-one cases (2.2%) and none of the controls were double heterozygotes. The odds ratio for venous thrombosis in double heterozygotes was 20.0 (11.1-36.1). Twelve percent of patients heterozygous for factor V Leiden were also heterozygous for factor II G20210A and conversely 23% of patients heterozygous for factor II G20210A were also heterozygous for factor V Leiden. Furthermore, in this large population we analyzed the effect of oral contraceptive (OC) in women carrying one of these mutations. Odds ratio for VTE associated with OC was 2.29 (1.72-3.04). In factor V Leiden carriers using OC, the odds ratio for VTE was 10.25 (5.69-18.45). The odds ratio of the association of factor II mutation and OC use was 7.14 (3.39-15.04). Finally, we also confirmed that the frequency of factor V Leiden was lower in patients with pulmonary embolism than in patients with deep vein thrombosis without PE (odds