Study Design

Study Design:

Patients Enrolled: 1,102
Mean Follow Up: 30 days
Mean Patient Age: Mean 60 years
Female: 25
Mean Ejection Fraction: Mean 51%

Patient Populations:

Any of the following: acute MI <48 hours before stenting; abrupt closure with TIMI grade 0 or 1 flow; threatened abrupt closure (TIMI grade 2 flow or angina with significant residual dissection in a target vessel <3.0 mm) before stenting; ejection fraction <35%; total occlusion of target vessel <7 days; stenting of a degenerated saphenous vein graft <4 mm in diameter with diffuse distal vessel disease; placement of a 2.5 mm diameter stent in a vessel ≤2.5 mm; placement of ≥1 stents in a true bifurcation lesion; or any of the following by angiography or ultrasound: intracoronary thrombus, diffuse distal disease, persistent filling defect within the stent, persistent dissection at the stent margin, or suboptimal stent deployment based on residual angiographic stenosis >20% or incomplete stent apposition by ultrasound

Exclusions:

Contraindication to anticoagulation; uncontrolled hypertension; hemoglobin <9 mg/dl; platelet count <100,000/mm³; glycoprotein IIb/IIIa inhibitor or dipyridamole therapy within <72 hours; thrombolysis <6 hours; planned coronary artery bypass graft or PCI within 30 days; other indications for anticoagulation; groin hematoma at sheath site >5 cm after stenting; allergy or intolerance to aspirin, ticlopidine, heparin, or any low molecular weight heparin; prior heparin-associated thrombocytopenia; pork allergy; unwillingness or inability to give or receive subcutaneous injections; or serious noncardiac illness

Primary Endpoints:

Composite of all-cause mortality, nonfatal MI, or urgent revascularization at 30 days. Only MIs that were deemed to have occurred after study drug initiation (thus in general excluding periprocedural MIs) were counted in the primary efficacy analysis.

Secondary Endpoints:

Incidence of the composite endpoint at 14 days, death or MI at 14 and 30 days, adverse events, major bleeding, minor bleeding, and thrombocytopenia (platelet count <100,000/mm³)

Drug/Procedures Used:

Stents were implanted in the standard manner according to local practice. Vascular access sheaths were removed ≥4 hours after procedural unfractionated heparin (UFH). At vascular sheath removal, patients were randomized to receive subcutaneous enoxaparin twice daily (40 mg for patients <65 kg, 60 mg for patients >65 kg) or matching placebo for 14 days. The first injection of the study drug was given ≥2 hours after sheath removal and 4-10 hours after the last dose of UFH.

Concomitant Medications:

Aspirin 325 mg/day, starting on or before the day of stenting and continuing for ≥6 months. Ticlopidine 250 mg twice daily for 14 days, beginning ≤72 hours before stenting. “Loading” doses of aspirin (650 mg) and ticlopidine (500 mg) were recommended for patients not already taking either drug.