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Prepublished online as a Blood First Edition Paper on April 17, 2002; DOI 10.1182/blood-2002-01-0111.

Submitted January 15, 2002
Accepted February 25, 2002
Factor V Leiden and risk of arterial thrombosis.3 case-control and 3 prospective studies based onThe Copenhagen City Heart Study and 2 meta-analyses
Klaus Juul, Anne Tybjaerg-Hansen, Rolf Steffensen, Steen Kofoed, Gorm Jensen, and Borge G Nordestgaard*
Clinical Biochemistry, Herlev University Hospital, Herlev, Denmark
Clinical Biochemistry, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; The Copenhagen City Heart Study, Bispebjerg University Hospital, Bispebjerg, Denmark
Medicine B, Hillerod Hospital, Hillerod, Denmark
Vascular Surgery, Gentofte University Hospital, Gentofte, Denmark
The Copenhagen City Heart Study, Bispebjerg University Hospital, Bispebjerg, Denmark
Clinical Biochemistry, Herlev University Hospital, Herlev, Denmark; The Copenhagen City Heart Study, Bispebjerg University Hospital, Bispebjerg, Denmark
* Corresponding author; email: brno{at}herlevhosp.kbhamt.dk.
Background: Factor V Leiden (FVL) is associated with venous thrombosis; however, an association between FVL and arterial thrombosis remains controversial.
Objective: We investigated FVL as a risk factor for myocardial infarction (MI), ischemic stroke (IS), or non-MI ischemic heart disease (non-MI-IHD).
Design: 3 case-control studies and 3 prospective studies with 21 years follow-up.
Setting: General population, Copenhagen, Denmark.
Participants: Copenhagen City Heart Study 20-95 year old participants without cardiovascular disease (=control population, n=7,907) or participants diagnosed with MI (n=469), IS (n=231) or non-MI-IHD (n=365). In addition, 3 independent patient populations from Copenhagen University Hospital with MI (n=493), IS (n=231) or non-MI-IHD (n=448).
Measurements: FVL genotype, major cardiovascular risk factors, MI, IS, and non-MI-IHD incidence and prevalence.
Results: Prevalences of FVL heterozygotes and homozygotes in controls from the general population were 7.7% and 0.2%. Odds ratios and relative risks of MI in FVL carriers (=heterozygotes+homozygotes) vs. non-carriers were 1.24 (95% CI: 0.91-1.69) and 0.83 (0.58-1.20) in case-control and prospective studies, respectively. Corresponding risks for IS were 0.92 (0.56-1.53) and 0.68(0.45-1.04), and for non-MI-IHD 1.01 (0.71-1.44) and 0.97 (0.66-1.42).
Conclusion: Findings from The Copenhagen City Heart Study suggest that FVL is not associated with MI, IS or non-MI-IHD.

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