Study Design

Study Design:

Patients Enrolled: 354
Mean Follow Up: 6 months

Patient Populations:

Age 18 to 75 years, had angina and/or objective evidence of myocardial ischemia, and were scheduled for balloon angioplasty of a significant (> 50%) stenosis that was documented on a recent coronary angiogram.

Exclusions:

Women of childbearing potential, recent myocardial infarction (< 3 weeks), insulin-dependent diabetes, severe uncontrolled hypertension, renal or hepatic impairment, history of bleeding, history of thrombocytopenia, history of allergy, contraindications to aspirin or to heparin, participation in another study, recent major surgery, treatment with oral anticoagulants, inability to give informed consent, or low likelihood of follow-up angiography because of a coexisting medical condition. Angiographic exclusion criteria were restenosis lesions, significant left main coronary artery disease, target lesions in a coronary bypass graft or in a vessel that was totally occluded, and perfusion grade of 0 or 1 as defined by the TIMI Investigators.

Primary Endpoints:

Angiographic restenosis defined as a residual stenosis of < 50% after angioplasty that became ≥50% at follow-up.

Secondary Endpoints:

Occurrence of death, nonfatal target lesion myocardial infarction, coronary artery bypass graft surgery, or repeat target-vessel angioplasty within the 6 months after the procedure. Hemorrhage was considered to be major if it required premature treatment cessation.

Drug/Procedures Used:

Elective coronary angioplasty was performed on 354 patients who were treated with daily subcutaneous nadroparin (0.6 mL of 10 250 anti-Xa IU/mL) or placebo injections started 3 days before angioplasty and continued for 3 months. Angiography was performed just before and immediately after angioplasty and at 6-month follow-up.