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Blood, 15 March 2002, Vol. 99, No. 6, pp. 1938-1942
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Incidence of venous thromboembolism in asymptomatic family
members who are carriers of factor V Leiden: a prospective cohort
study
Paolo Simioni,
Daniela Tormene,
Paolo Prandoni,
Patrizia Zerbinati,
Sabrina Gavasso,
Philip Cefalo, and
Antonio Girolami
From the Department of Medical and Surgical Sciences,
Second Chair of Internal Medicine, University of Padua Medical School,
Italy.
In a prospective cohort study, we assessed the incidence of
spontaneous and risk period-related venous thromboembolism (VTE) in
asymptomatic family members of patients who experienced VTE and had the
factor V Leiden mutation. In all, 561 family members of 131 probands
were included, 313 of whom were carriers (299 heterozygous and 14 homozygous) and 248 of whom were noncarriers of the factor V Leiden
mutation. Average follow-up was 4 years (range, 4 months-6 years).
There were 1255 and 984 observation-years of follow-up in carriers and
noncarriers, respectively. Eight episodes of VTE occurred in
heterozygous carriers, resulting in an annual incidence of 0.67% (95%
confidence interval [CI], 0.29-1.33). Two events occurred in the
absence of associated risk factors, determining an annual incidence of
spontaneous VTE of 0.17% (95% CI, 0.02-0.6). Only one VTE (risk
period-related) occurred in noncarriers, with an annual incidence of
0.1% (95% CI, 0.003-0.56). Relative risk for VTE in heterozygous
carriers compared with noncarriers of the factor V Leiden mutation was
6.6 (95% CI, 1.1-39.8). Risk period-related VTE occurred with an
incidence of 18% and 5% per risk period in heterozygous
carriers and in noncarriers, respectively. Thus, the low rate of VTE in
asymptomatic family members carrying the mutation did not justify
continuous anticoagulant prophylaxis. Screening families of symptomatic
probands with the factor V Leiden mutation has the potential to
identify those asymptomatic carriers who might benefit from
thromboprophylaxis during risk periods.
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