Randomized Comparison of Ticlopidine and Clopidogrel After Intracoronary Stent Implantation in A Broad Patient Population - Ticlopidine versus Clopidogrel After Intracoronary Stent Implantation
Randomized Comparison of Ticlopidine and Clopidogrel After Intracoronary Stent Implantation in A Broad Patient Population.
To determine the relative safety of a 2-week treatment with clopidogrel plus aspirin compared to ticlopidine plus aspirin in patients undergoing coronary stenting.
Patients Enrolled: 1067
Failure to complete the 2-week therapy.
Major bleeding, thrombocytopenia, cardiac death, stent thrombosis, Q-wave myocardial infarction and target vessel revascularization and a combined major adverse cardiac event end point (MACE) including acute closure, stent thrombosis, 30-day closure, target vessel revascularization and cardiac death.
1067 patients who had undergone successful stent implantation were randomized to receive a loading dose of ticlopidine 500mg followed by ticlopidine 250mg BID plus aspirin 325 mg/d for 14 days (522 patients) or a loading dose of clopidogrel 300mg followed by clopidogrel 75 mg/d plus aspirin 325 mg/d for 14 days (494 patients).
The primary end point occurred in 3.64% of patients in the ticlopidine group and in 1.62% of patients in the clopidogrel loading dose group (p=0.04). The most common adverse event requiring discontinuation of ticlopidine was the development of a rash (0.96% in the ticlopidine group and 0.2% in the clopidogrel group). There were no significant differences between the two groups in the incidence of thrombocytopenia (0.57% in the ticlopidine group and 1.01% in the clopidogrel group) and neutropenia (respectively 0.38% and 0%). There was a trend toward a higher incidence of cardiac death in the ticlopidine group (1.53% vs. 0.61%), while the incidence of stent thrombosis was similar among the two groups (2.02% vs. 1.92%). The predominance of stent thrombosis occurred during the first 8 days of treatment, while only one event per group occurred after the 2-week treatment period. At 30-day follow-up, the incidence of MACE was 4.6% in the ticlopidine group and 3.85% in the clopidogrel group.
Clopidogrel has a higher safety and tolerability than ticlopidine and similar efficacy in the prevention of stent thrombosis and major adverse cardiac events following coronary stenting.
This study confirms the results of other studies, and it supports the use of clopidogrel as a preferred alternative to ticlopidine after coronary stenting. Although the results suggest that a 14-day regimen of a thienopyridine is safe in the majority of patients undergoing stent implantation, the two stent thromboses occurring outside the 14-day treatment period suggests the need for other randomized trials to further define optimal duration of therapy with thienopyridines after stent implantation.
1. Taniuchi M, Kurz HI, Lasala JM. Circulation 2001;104:539-43.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention
Keywords: Neutropenia, Follow-Up Studies, Platelet Aggregation Inhibitors, Thrombosis, Coronary Disease, Ticlopidine, Purinergic P2Y Receptor Antagonists, Thrombocytopenia, Exanthema, Stents, Thienopyridines
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