To determine whether factor V Leiden is associated with thrombotic eve
nts in patients with heparin-induced thrombocytopenia (HIT), we evalua
ted 165 patients with serologically confirmed HIT for the presence of
factor V Leiden and determined the incidence of venous or arterial thr
ombosis during the period of HIT. Factor V Leiden was detected in 16 o
f 165 HIT patients (9.7%). HIT-associated venous thrombosis occurred i
n 11 of 16 factor V Leiden positive subjects and 94 of 149 factor V Le
iden negative subjects (69% vs. 63%; p = 0.79). Arterial thrombosis oc
curred in 1 of 16 factor V Leiden positive subjects and 21 of 149 fact
or V Leiden negative subjects (6% vs. 14%; p = 0.70). There was no dif
ference in the incidence of proximal limb DVT, pulmonary embolism, ven
ous limb gangrene, local skin reactions, hemorrhagic adrenal infarctio
n, stroke, or myocardial infarction between the groups. No difference
in the severity of venous thrombosis between Leiden positive and negat
ive subjects was detected. Our data suggest that in the acute prothrom
botic milieu of HIT, heterozygous factor V Leiden is not an important
additional risk factor for thrombosis.