The purpose of the present study was to evaluate patients with the ant
iphospholipid syndrome with particular attention to their initial clin
ical features, final diagnoses and the course of thrombotic events in
association with therapy. The methodology applied was the following: r
etrospective analysis of 30 patient files (20 female, 10 male) with an
tiphospholipid syndrome (APS). Four types of therapy were evaluated fo
r their efficacy to prevent thrombotic recurrences, aspirin 100 mg dai
ly plus low-dose prednisone 10-15 mg daily, warfarin (with internation
al normalized ratio 2 to 2.6), immunotherapy alone and no therapy. Non
e of the patients was followed-up during pregnancy. The probability of
thrombosis-free survival was estimated according to Kaplan-Meier meth
od, while the statistical significance was tested by the log rank test
. There were 21 patients with primary APS and 9 with secondary, 8 of w
hom had SLE and one patient who had primary Sjogren's syndrome. The ag
e at onset and the disease duration did not differ between men and wom
en, while patients with secondary APS had a longer disease duration th
an patients with primary APS, a finding indicating that SLE patients d
evelop, for unknown reasons, APS a long time after the initiation of t
heir disease. Twenty patients experienced recurrent thrombotic events
(a total of 46 recurrences) of which 43 (93%) were identical to the fi
rst event. Thus, in the majority of the cases arterial were followed b
y arterial and venous by venous thrombotic events: a finding suggestin
g a tissue-related factor for initiation of thromboses. Total follow-u
p of the patients was 154 patient years, of which 98 patient years wer
e after the first thrombotic episode. More specifically: aspirin plus
low-dose prednisone, 38 patient years; warfarin therapy, 15; immunothe
rapy alone, 10; no therapy, 35. The recurrence rates of thrombotic eve
nts were 0.13, 0.20, 0.70 and 0.88, respectively. The thrombosis-free
survival after the first thrombotic event was significantly longer wit
h aspirin plus low-dose of prednisone and warfarin therapy than with n
o therapy (P < 0.005 and P < 0.05, respectively). Immunotherapy alone
did not prolong significantly the thrombosis-free survival compared wi
th no therapy. Prospective studies are necessary to identify the optim
um type and duration of therapy. Although immunotherapy and warfarin t
herapy cannot be definitely tested due to the small number of patients
, the short follow-up and in the case of warfarin the low intensity of
therapy, our data suggests that aspirin with low doses of prednisone
and warfarin seem to be the most effective anti-thrombotic therapies i
n APS.