Randomized comparison of ticlopidine and clopidogrel after intracoronary stent implantation in a broad patient population

Background-Although clopidogrel is used to prevent subacute stent thrombosi s, its safety and efficacy have not been compared with ticlopidine in a ran domized manner in the United States. Methods and Results-Patients with successful intracoronary stent implantati on were randomly assigned to therapy with ticlopidine or clopidogrel. Loadi ng doses were administered immediately after the procedure, and the drugs w ere prescribed for 2 weeks. One thousand sixteen patients were enrolled: 52 2 patients were randomly assigned to ticlopidine therapy and 494 to clopido grel. High-risk characteristics included recent myocardial infarction in 41 .4% of the cases, angio graphically evident thrombus in 20.9%, and abrupt o r threatened closure in 3.64%. An intravenous glycoprotein IIb/IIIa inhibit or was used in 48.2% of the cases, and thrombocytopenia occurred in 1.43% o f these patients. Failure to complete 2 weeks of therapy occurred in 3.64% of the patients treated with ticlopidine and in 1.62% of the patients treat ed with clopidogrel (P=0.043). Within 30 days, thrombosis of the stent occu rred in 1.92% of the patients in the ticlopidine group and in 2.02% of the clopidogrel group (P=0.901). A major adverse cardiac event occurred in 4.60 % of patients receiving ticlopidine and in 3.85% of patients receiving clop idogrel (P=0.551). Conclusions-Clopidogrel is better tolerated than ticlopidine during a 2-wee k regimen after intracoronary stent implantation. Combining either thienopy ridine with an intravenous platelet IIb/IIIa inhibitor appears to be safe. When applied to a broad spectrum of patients receiving stent implantation, clopidogrel confers similar protection as ticlopidine against subacute sten t thrombosis and major adverse cardiac events.