Study Design

Study Design:

Patients Enrolled: 350
Mean Follow Up: 30 days
Mean Patient Age: Mean 60.4 ± 9.9 years
Female: 24

Patient Populations:

Patients were eligible to participate in this study if they met at least one of the following criteria after their coronary stenting procedure: bailout stenting for acute vessel closure or dissection, suboptimal stenting result (i.e., >20% residual stenosis within the stent, residual dissection, >30% stenosis immediately proximal or distal to the stent, or reduced flow after stent implantation), ≥3 stents placed within the same vessel, total length of stents ≥45 mm, or maximal nominal balloon diameter used was ≤2.5 mm.

Exclusions:

The exclusion criteria included: recent myocardial infarction, persistent ischemia at the time of randomization, age <18 years, pregnancy, difficulties with follow-up, use of glycoprotein (GP) IIb/IIa antagonists in the periprocedure period or the planned use of GP IIb/IIa antagonists during the follow-up period, need for oral anticoagulation, contraindications to any of the study medications, and participation in another study within the prior 30 days.

Primary Endpoints:

The composite primary endpoint was cardiovascular events at 30 days. Cardiovascular events were defined as the occurrence of cardiovascular death, myocardial infarction, or repeat revascularization.

Secondary Endpoints:

The secondary endpoints of this study were major bleeding or vascular complications. These were defined as the need for surgical repair of the vascular access site, bleeding with a subsequent decrease in hemoglobin by ≥4 g/dl, or requiring a transfusion of ≥2 units of blood, or retroperitoneal or intracranial hemorrhage.

Drug/Procedures Used:

Eligible patients were randomized to receive either dual antiplatelet therapy with aspirin and ticlopidine or aspirin and oral anticoagulation therapy in an open-label fashion. Those randomized to the dual antiplatelet therapy group received aspirin 250 mg/day and ticlopidine 250 mg BID, with the entire daily dose of 500 mg given as a single dose on the first day.

Individuals in the aspirin and oral anticoagulation group received aspirin 250 mg/day and oral anticoagulation to a target international normalized ratio (INR) of 2.5 to 3.0. Intravenous heparin was continued until the target INR was achieved in two consecutive measurements separated by ≥24 hours.