A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab

A Multicenter, Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention

The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results.

Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.

Inclusion Criteria:

• Patients referred for elective or urgent percutaneous coronary intervention
• Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation
• Having a target artery (native or graft) stenosis of >= 60% (visual estimation)

Exclusion Criteria:

• Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours
• With a planned staged procedure or having an unprotected left main coronary artery stenosis > 50%
• With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry
• Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel
• Having hypertension with systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg at the time of study entry, or a platelet count < 100,000/μL at baseline