J. Blanchard et al., RESULTS OF EMATAP - A DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER TRIAL OF TICLOPIDINE IN PATIENTS WITH PERIPHERAL ARTERIAL-DISEASE, Nouvelle revue francaise d'hematologie, 35(6), 1993, pp. 523-528
EMATAP, a randomized stratified, placebo-controlled double-blind multi
centre trial was: performed in Argentina in order to confirm the effec
t of ticlopidine in the prevention of thrombotic events in patients wi
th intermittent claudication. Twenty-one clinical centres enrolled 615
patients, 304 (88 diabetic and 216 non diabetic) were assigned to the
ticlopidine group and 311 (95 diabetic and 216 non diabetic) to the p
lacebo group. Treatments were given for 24 weeks. The baseline charact
eristics were identical in both groups. The compliance was good and on
ly 34 patients (17 in each group) did not I-each the last visit. Their
status however was checked and known at that time and according to th
e protocol, there was no patient lost to follow-up. Twenty-five patien
ts experienced a first event during the follow-lip period and the resu
lts show a very dramatic reduction of events in the ticlopidine group
(5 vs 20), the difference being highly significant (p = 0.002) in inte
ntion-to-treat analysis. If we consider the subgrouping of outcome eve
nts: sudden deaths, myocardial infarctions and strokes on the one hand
vascular surgery on the other hand a significant reduction is found i
n the ticlopidine group. Taking into account the total deaths plus non
-fatal events (9 vs 21), the results were also significant (p = 0.027)
. These above results therefore demonstrate a consistent reduction in
all outcome events. As regard side effects there were fewer gastro-int
estinal disturbances and skin reactions than seen in North American tr
ials. However these events were the main reason for premature terminat
ion of treatment. In this trial, the haematological profile was safe.
This propective trial confirms the efficacy of ticlopidine in the prev
ention of thrombotic events in patients with peripheral arterial disea
se.