Study Design

• Parallel

Patients Enrolled: 503
Mean Follow Up: 30 days
Mean Patient Age: Median: 63.8 years
Female: 28

Patient Populations:

• Age ≥19 years
• Stable coronary artery disease amenable to PCI

Exclusions:

• ACT >200 seconds before study drug administration
• Hemoglobin <10 mg/dl="">
• Platelet count <100,000 or="">600,000/mm³
• Creatinine clearance <30 ml/min="">
• Baseline aspartate aminotransferase/alanine aminotransferase >upper limit of normal
• MI within 7 days of index procedure
• Known allergy to heparin, pork, or pork-related contents
• Suspected aortic dissection
• Stroke/transient ischemic attack within 3 months of index procedure
• Active bleeding or bleeding diathesis (including need for oral anticoagulant therapy)
• Hemodynamic instability at the time of PCI
• Trauma or major surgery in the 30 days before index PCI, or planned surgery within 30 days of PCI
• Receipt of LMWH within the 12 hours before PCI if creatinine clearance is >60 ml/min or within 24 hours before PCI if creatinine clearance is &le;60 ml/min
• Planned use of GP IIb/IIIa inhibitors, or atherectomy
• Target vessel is unprotected left main coronary artery, or chronic total occlusion present for &ge;3 months

Primary Endpoints:

• Composite of death/MI/repeat revascularization/stroke/24-hour thrombocytopenia/24-hour major + minor bleeding/bailout use of GP IIb/IIIa inhibitors during the index PCI/catheter-related thrombus formation during index PCI at 30 days
• Protocol defined major and minor bleeding

Secondary Endpoints:

• Primary endpoint excluding bleeding
• Death or MI
• Death, MI, or revascularization
• Death, MI, revascularization, or major bleeding

Drug/Procedures Used:

Study drug was administered as an intravenous bolus before the coronary guidewire crossed the lesion. For patients assigned to UFH, the initial dose was 70 U/kg (maximum 5000 U), and a minimum activated clotting time (ACT) of 200 seconds was necessary before the lesion could be crossed. Additional boluses of 20 U/kg could be administered if the ACT value before or during PCI was &le;200. Patients randomized to the M118 arms received either 50, 75, or 100 IU/kg of M118.

Because the optimal ACT value for M118 during PCI has not been established, additional M118 boluses were guided by procedure duration and not by specific ACT values: An additional bolus of one-half of the initial M118 dose was given (25, 37.5, or 50 IU/kg) if the procedure was not completed 30 minutes after the initial bolus. Further boluses at one-half the initial dose were given at subsequent 30-minute intervals if needed.

Concomitant Medications:

All patients were required to receive 325 mg of aspirin within 12 hours of the index PCI and &ge;300 mg of clopidogrel within 6 hours of the index PCI. Aspirin was then continued at a dose of 75-325 mg daily for &ge;30 days. Similarly, clopidogrel was continued at a dose of 75 mg daily for 30 days.