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Blood, 15 November 2000, Vol. 96, No. 10, pp. 3329-3333
PLENARY PAPER
Risk for subsequent venous thromboembolic complications in
carriers of the prothrombin or the factor V gene mutation with a
first episode of deep-vein thrombosis
Paolo Simioni,
Paolo Prandoni,
Anthonie W. A. Lensing,
Davide Manfrin,
Daniela Tormene,
Sabrina Gavasso,
Bruno Girolami,
Corrado Sardella,
Martin Prins, and
Antonio Girolami
From the Department of Medical and Surgical Sciences,
Second Chair of Internal Medicine, University Hospital of Padua, Italy;
and the Centre for Vascular Medicine and the Department of Clinical
Epidemiology and Biostatistics, Academic Medical Centre, University of
Amsterdam, Netherlands.
Carriers of a mutation in the prothrombin (clotting factor
II) or factor V gene have a 2- to 4-fold greater risk for venous thromboembolism than subjects without the mutations. Whether both mutations also predispose to recurrent venous thromboembolism is
unclear. Outpatients who had a first episode of proven symptomatic deep-vein thrombosis and a long-term follow-up were studied. The outcome measure was the cumulative incidence of confirmed venous thromboembolic complications. Two hundred fifty-one patients were enrolled in the study. Mean duration of follow-up was 8.3 years. The
prothrombin gene mutation was demonstrated in 27 patients (prevalence,
10.8%; 95% CI, 6.9 to 14.6), and the factor V gene mutation was
demonstrated in 41 patients (prevalence, 16.3%; 95% CI, 11.8 to
20.9). The cumulative incidence of venous thromboembolic complications
after 10 years was 61.3% (95% CI, 35.7 to 87.9), and the hazard ratio
was 2.4 (95% CI, 1.3 to 4.7; P = .004) in patients with
the prothrombin gene mutation); the cumulative incidence of venous
thromboembolic complications after 10 years was 55.2% (95%
CI, 36.4 to 74.0), and the hazard ratio was 2.4 (95% CI, 1.4 to 4.1;
P = .001) in patients with the factor V gene mutation. In
comparison, the cumulative incidence of venous thromboembolic complications after 10 years was 23.1% (95% CI, 16.2 to 30.1) in patients without the mutations. Prothrombin and factor V gene mutations occur frequently in patients with venous thrombosis and are
associated with an increased risk for recurrent venous thromboembolic
complications
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