Thrombophilia, Factor V Leiden

Definition

The Leiden variant in the F5 gene disrupts the natural brake of the clotting system and increases the risk of venous thromboembolism (VTE).

Risk levels:

GenotypeRelative risk of VTENote
Heterozygous~3 to 8-fold increaseAnnual incidence of first VTE ~0.5%. Adjusted HR: 2.7 (95% CI 1.8 to 3.8)
Homozygous~9 to 80-fold increaseAdjusted HR: 18 (95% CI 4.1 to 41). Thrombosis tends to occur at a younger age

Frequency in the population: Heterozygosity for the Factor V Leiden variant is seen in 3 to 8% of the general US and European populations. The frequency of homozygosity is about 1:5,000.

Results / Clinical significance: The most important limitation of the test is that it usually does not change treatment:

For asymptomatic heterozygous individuals, long-term prophylactic anticoagulation is not routinely recommended, because the bleeding risk exceeds the thrombosis risk.

The test mainly helps with decision-making in high-risk situations:

  • Pregnancy
  • Use of oral contraceptives (birth control pills)
  • Major surgery, prolonged immobility

What the patient should know: A positive Factor V Leiden result does not mean "you will be on blood thinners for life." Most carriers never develop a clot.

Inheritance

Autosomal dominant

Related Tests