Efficacy and safety of ticlopidine monotherapy versus ticlopidine and aspirin after coronary artery stenting: follow-up results of a randomized study.

A combined antiplatelet treatment with ticlopidine and aspirin has been accepted as standard pharmacological regimen after coronary artery stenting. No data of a randomized trial are available on ticlopidine monotherapy. This prospective, randomized monocenter trial investigates the role of ticlopidine monotherapy versus combined antiplatelet therapy with ticlopidine and aspirin in unselected patients undergoing coronary artery stenting. After successful placement of 378 coronary artery stents, two hundred and forty-three consecutive patients were randomly assigned to receive antiplatelet therapy with 2 x 250 mg ticlopidine (121 patients) or a combination of 2 x 250 mg ticlopidine plus 100 mg aspirin (122 patients) daily. The primary endpoint included the absence of death, cardiac events and vascular access-site complications during the in-hospital phase. Angiographic and clinical assessment was repeated at the 3-month follow-up exam. Two hundred and thirty-seven patients (97.5%) were free from cardiac and non-cardiac events. Stent thromboses were seen in 2 patients of the combined treatment group, while none were observed in the monotherapy group. No statistically significant differences were found between the 2 groups regarding the primary endpoint. Angiography performed in 210 patients (86.4%) at follow-up revealed a restenosis rate of 29.4% in the combined treatment group and 27.8% in the monotherapy group. Monotherapy with ticlopidine is as safe and effective as a combined regimen of ticlopidine plus aspirin after coronary artery stenting in an unselected patient population. These results need to be confirmed in a larger multicenter trial.