Effect of Nadroparin, a Low-Molecular-Weight Heparin, on Clinical and Angiographic Restenosis After Coronary Balloon Angioplasty - FACT
The FACT was a prospective multicenter, double-blind, randomized trial designed to evaluate whether treatment with nadroparin, a low-molecular-weight heparin, started 3 days before coronary angioplasty and continued for 3 months, affects angiographic restenosis or clinical outcomes.
Pretreatment with the low-molecular-weight heparin nadroparin continued for 3 months after balloon angioplasty will have a beneficial effect on angiographic restenosis or on adverse clinical outcomes.
Patients Enrolled: 354
Mean Follow Up: 6 months
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.
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.
Angiographic restenosis defined as a residual stenosis of < 50% after angioplasty that became ≥50% at follow-up.
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.
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.
175 patients were randomized to receive nadroparin and 179 patients were randomized to the control group. The groups were well matched for all variables apart from smoking, which was more frequent in the control group (P=0.035). The mean MLD did not differ significantly between groups before angioplasty, immediately after angioplasty, or at follow-up. The late loss and loss index did not differ significantly between groups. The restenosis rate in the nadroparin group was 41.0% compared with 38.8% in the control group (P = 0.75). The combined rate of major events was similar in the groups (30.3% in the nadroparin group versus 29.6% in the control group), as was the time course of such events (P=NS). Death at 6 months occurred in 0.6% for the nadroparin versus 1.7% for the placebo group, whereas acute MI occurred in 4.4% versus 2.2%, respectively. CABG was performed in 10.9% of patients in the nadroparin group vs 4.5% of patients in the placebo group. Repeat PTCA was performed in a larger percentage of patients in the placebo group (21.2% vs 14.9%). Major hemorrhagic complications were significantly higher in the nadroparin group (3.4%) compared to control (0%; p=0.012).
Among patients undergoing percutaneous angioplasty, treatment with the low-molecular-weight nadroparin was not associated with improvements in clinical or angiographic outcomes. However, major hemorrhagic complications were significantly higher in the nadroparin group.
Lablanche JM, et al. Effect of Nadroparin, a Low-Molecular-Weight Heparin, on Clinical and Angiographic Restenosis After Coronary Balloon Angioplasty: The FACT Study. Circulation 1997;96:3396-3402.
Keywords: Follow-Up Studies, Coronary Angiography, Heparin, Low-Molecular-Weight, Constriction, Pathologic, Nadroparin, Angioplasty, Balloon, Coronary, Smoking
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