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Folate After Coronary Intervention Trial - FACIT
Description:
The goal of the Folate After Coronary Intervention Trial (FACIT) was to evaluate the efficacy of folate in combination with vitamin B6 and B12 in prevention of restenosis after stent placement.
Study Design
Study Design:
Patients Enrolled: 636
Mean Follow Up: 250-day clinical follow-up; six-month angiographic follow-up
Mean Patient Age: Mean age 61 years
Female: 23%
Patient Populations:
Performance of elective stent implantation.
Exclusions:
Presence of in-stent restenosis, bifurcation lesion, acute MI <24 hours, serum creatinine >1.5, and multivitamin use.
Primary Endpoints:
MLD and binary restenosis rate at six-month angiographic follow-up.
Secondary Endpoints:
Major adverse clinical events (death, myocardial infarction [MI], and target vessel revascularization).
Drug/Procedures Used:
All patients underwent successful coronary stent placement. Patients were randomized to placebo (n=320) or folic acid (1 mg), vitamin B6 (5 mg), and B12 (1 mg) intravenously immediately after the procedure (n=316), followed by daily oral doses of folate (1.2 mg), vitamin B6 (48 mg), and vitamin B12 (0.06 mg).
Principal Findings:
Homocysteine levels were significantly lowered by 44 weeks in the folate arm from 12.2 to 9.0 μmol/l (p<0.001), but remained unchanged in controls (12.9 vs. 13.3 μmol/l). At six-month angiographic follow-up, minimal lumen diameter (MLD) in 531 lesions was significantly smaller in the folate arm compared with controls (1.59 vs. 1.74 mm, p<0.01). Late loss was larger in the folate arm versus control (0.90 mm vs. 0.76 mm, p=0.004), as was loss index (0.61 vs. 0.51, p=0.001).
Binary restenosis occurred more frequently in the folate arm versus controls (35% vs. 27%, p<0.05), as did major adverse clinical events at 250 days (16.8% vs. 10.9%, p<0.05), primarily due to a higher rate of target vessel revascularization (15.8% vs. 10.6%, p<0.05). Similar results occurred across subgroups with the exception of females and diabetics, which showed a nonsignificant benefit in restenosis favoring folate therapy.
Interpretation:
Among patients undergoing successful coronary stent placement, treatment with folate in combination with vitamin B6 and B12 was associated with increased restenosis, decreased MLD, and increased adverse events. Treatment with folate is often administered to patients with coronary artery disease to lower homocysteine levels. While the present study showed that homocysteine levels were lower with folate therapy, there was no clinical or angiographic benefit with folate therapy.
An earlier single-center study showed the combination of folate and vitamin B6 and B12 to be associated with a significant reduction in restenosis rate after coronary balloon angioplasty, but less of a benefit in patients treated with coronary stenting. Given these findings and that of the earlier study, folate therapy should not be initiated following stent placement.
References:
Presented at Late-Breaking Clinical Trials, ACC 2003.
Keywords: Coronary Artery Disease, Vitamin B 6, Follow-Up Studies, Folic Acid, Vitamin B 12, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents
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