BACKGROUND: The efficacy and safety of sarpogrelate, a selective 5-hydroxytryptamine receptor subtype 2A antagonist, have not yet been established in bare metal coronary stenting. Accordingly, we sought to clarify whether treatment with sarpogrelate is clinically useful in bare metal coronary stenting. METHODS: A total of 450 patients who underwent successfully planned or unplanned bare metal coronary stenting were randomly divided into the following 2 groups: the sarpogrelate (300 mg/day) plus aspirin (100 mg/day) group (group S, n=225) and the ticlopidine (200 mg/day) plus aspirin (100 mg/day) group (group T, n=225). Either sarpogrelate or ticlopidine was administered for at least 4 weeks after the procedure. Follow-up coronary arteriography was performed at 6 months after the procedure. The primary endpoints were the incidence of adverse drug reactions requiring a withdrawal of treatment and the rate of binary restenosis. The secondary endpoint was the incidence of stent thrombosis. RESULTS: The incidence of adverse drug reactions requiring a withdrawal of treatment was significantly lower in group S than in group T (0.44% vs 8%, p=0.002). The rate of binary restenosis did not differ significantly between groups S and T (16.9% vs 18.2%). In addition, the incidence of subacute stent thrombosis did not differ between groups S and T (0.44% vs 0.44%). CONCLUSIONS: The incidence of adverse drug reactions requiring a withdrawal of treatment was significantly lower with sarpogrelate use than with ticlopidine use. The rate of binary restenosis and the incidence of subacute stent thrombosis did not differ between both drug groups.
RCT Entities:
BACKGROUND: The efficacy and safety of sarpogrelate, a selective 5-hydroxytryptamine receptor subtype 2A antagonist, have not yet been established in bare metal coronary stenting. Accordingly, we sought to clarify whether treatment with sarpogrelate is clinically useful in bare metal coronary stenting. METHODS: A total of 450 patients who underwent successfully planned or unplanned bare metal coronary stenting were randomly divided into the following 2 groups: the sarpogrelate (300 mg/day) plus aspirin (100 mg/day) group (group S, n=225) and the ticlopidine (200 mg/day) plus aspirin (100 mg/day) group (group T, n=225). Either sarpogrelate or ticlopidine was administered for at least 4 weeks after the procedure. Follow-up coronary arteriography was performed at 6 months after the procedure. The primary endpoints were the incidence of adverse drug reactions requiring a withdrawal of treatment and the rate of binary restenosis. The secondary endpoint was the incidence of stent thrombosis. RESULTS: The incidence of adverse drug reactions requiring a withdrawal of treatment was significantly lower in group S than in group T (0.44% vs 8%, p=0.002). The rate of binary restenosis did not differ significantly between groups S and T (16.9% vs 18.2%). In addition, the incidence of subacute stent thrombosis did not differ between groups S and T (0.44% vs 0.44%). CONCLUSIONS: The incidence of adverse drug reactions requiring a withdrawal of treatment was significantly lower with sarpogrelate use than with ticlopidine use. The rate of binary restenosis and the incidence of subacute stent thrombosis did not differ between both drug groups.