Study Design

Study Design:

Patients Enrolled: 5,308
Mean Follow Up: 30 days
Mean Patient Age: 62 ± 1.7
Female: 27

Patient Populations:

Patients were included if they were scheduled to undergo a coronary stenting procedure of a newly stenotic or restenotic atherosclerotic lesion in a native vessel, or a bypass graft. All lesions judged to have stenosis of more than 70% on angiography had to be amenable to stenting for the patient to qualify.

Exclusions:

Patients with cardiogenic shock, ST elevation MI, serum creatinine =2.5 mg/dl, ongoing bleeding, or a platelet count <120,000 per cubic millimeter

Primary Endpoints:

Composite endpoint of death, nonfatal MI, or urgent TVR at 30 days

Secondary Endpoints:

Secondary endpoints included each component of the composite endpoint and the effect of the study medications on prespecified subgroups (diabetics, elderly, country in which the procedure was performed, and pretreatment with clopidrogel). The endpoints of major and minor bleeding complications were defined by the TIMI trials.

Drug/Procedures Used:

Patients received the study drug intravenously immediately before revascularization. Tirofiban was given as a bolus dose of 10 µg/kg, followed by an infusion of 0.15 µg/kg/min for 18 to 24 hours. Abciximab was given as a bolus dose of 0.25 mg/kg, followed by an infusion of 0.125 µg/kg/min (maximum, 10 µg/min) for 12 hours.

Concomitant Medications:

All patients received 250 to 500 mg of aspirin before the procedure and, when possible, were to receive a loading dose of clopidrogel of 300 mg two to six hours before the procedure. Both of these antiplatelet medications were continued throughout the 30-day study period at a daily dose of 75 to 325 mg for aspirin and 75 mg for clopidrogel.

Heparin was administered at the start of the procedure at a dose of no more than 70 U/kg; the target activated clotting time (ACT) was 250 seconds. The ACT was assessed five minutes after the study drug was administered and heparin use was guided by a predefined normogram.