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Randomized Comparison of Ticlopidine and Clopidogrel After Intracoronary Stent Implantation in A Broad Patient Population - Ticlopidine versus Clopidogrel After Intracoronary Stent Implantation
Description:
Randomized Comparison of Ticlopidine and Clopidogrel After Intracoronary Stent Implantation in A Broad Patient Population.
Hypothesis:
To determine the relative safety of a 2-week treatment with clopidogrel plus aspirin compared to ticlopidine plus aspirin in patients undergoing coronary stenting.
Study Design
Study Design:
Patients Enrolled: 1067
Primary Endpoints:
Failure to complete the 2-week therapy.
Secondary Endpoints:
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.
Drug/Procedures Used:
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).
Principal Findings:
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.
Interpretation:
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.
References:
1. Taniuchi M, Kurz HI, Lasala JM. Circulation 2001;104:539-43.
Keywords: Neutropenia, Follow-Up Studies, Platelet Aggregation Inhibitors, Thrombosis, Coronary Disease, Ticlopidine, Purinergic P2Y Receptor Antagonists, Thrombocytopenia, Exanthema, Stents, Thienopyridines
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