OBJECTIVES The study compared the safety and efficacy of ticlopidine with c
lopidogrel in patients receiving coronary stents.
BACKGROUND Stent thrombosis is reduced when ticlopidine is administered wit
h aspirin. Clopidogrel is similar to ticlopidine in chemical structure and
function but has fewer side effects; few data are available about its use i
n stent patients.
METHODS We compared 30-day event rates in 500 consecutive coronary stent pa
tients treated with aspirin and clopidogrel (300 mg loading dose immediatel
y prior to stent placement, and '75 mg/day for 14 days) to 827 consecutive
stent patients treated with aspirin and ticlopidine (500 mg loading dose an
d 250 mg twice daily for 14 days).
RESULTS Patients treated with clopidogrel had more adverse clinical charact
eristics including older age, more severe angina, and more frequent infarct
ion within the prior 24 h. Nonetheless, mortality was 0.4% in clopidogrel p
atients versus 1.1% in ticlopidine patients; nonfatal myocardial infarction
occurred in 0% versus 0.5%, stent thrombosis in 0.2% versus 0.7%, bypass s
urgery or repeal angioplasty in 0.4% versus 0.5%, and any event occurred in
0.8% versus 1.6% of patients, respectively (p = NS). Based on the observed
30-day event rate of 1.6% with ticlopidine, the statistical power of the s
tudy was 43% to detect an even rate of 0.5% with clopidogrel, and 75% to de
tect an event rate with of 4% with clopidogrel, with a p value of 0.05.
CONCLUSIONS These data indicate that clopidogrel can be safely substituted
for ticlopidine in patients receiving coronary stents. (C) 1999 by the Amer
ican College of Cardiology.