BACKGROUND: To analize hemorrhagic complications in a series of outpat
ients treated with acenocumarol in an anticoagulant specialized unit b
y a prospective observational clinical study. PATIENTS AND METHODS: 1,
200 outpatients (682 women/518 men, mean age 54.6 +/- 15.8 yrs.) treat
ed with acenocumarol for at least 6 weeks, with a total follow-up of 2
,795 patients-yr. Prevalence and incidence of bleeding was analyzed, T
he episodes that were potentially life-threatening, or forced to blood
transfusion or hospital patient admittance were considered as major b
leedings, and the remainder episodes were minor. RESULTS: There were 3
79 minor bleedings in 258 patients (incidence 13.56/100 patients-yr.),
45 major bleedings (1.61/100 patients-yr.) and 2 lethal bleedings (0.
07/100 patients-yr.). Minor bleedings correlated with more advanced ag
e (57.3 +/- 11.8 vs. 53.9 +/- 16.7 yrs., p = 0.002), with the first tw
o months In treatment in the 511 patients who start the treatment duri
ng the study (31.09 vs, 13.04/100 patients-yr., p < 0.001), and with a
worse achievement of the desired anticoagulation (72.4% vs, 81.6%; p
= 0.002), Major bleeding was associated with local causes in 48.9%, an
d with an excessive anticoagulation in 35.6%. CONCLUSIONS: Bleeding is
relatively frequent during acenocumarol therapy, mainly in patients w
ith worse control, but only in a few of these episodes is severe, and
is usually associated with local lesions.