Efficacy of folic acid therapy for prevention of in-stent restenosis: a randomized clinical trial.

Background: It is known that there is an association between elevated total plasma homocysteine level and restenosis after percutaneous coronary angioplasty.

Objective: To evaluate the effect of lowering plasma homocysteine levels on the rate of restenosis after stent-percutaneous coronary angioplasty.

Methods: Folic acid (1 mg) or placebo was administered to 200 patients (mean +/- SD age of 54 +/- 9 years) for 3 months, after successful coronary angioplasty in a double-blind randomized clinical trial. The primary end point was restenosis within six months, as assessed by quantitative coronary angiography after positive exercise tolerance test. The secondary end point was a composite of major cardiac events.

Results: Base line characteristics and initial angiographic results after stent-percutaneous coronary angioplasty were similar in the two study groups. The rate of restenosis showed no significant difference in the two groups (5% in placebo vs. 10% in folic acid groups; P = 0.141), as there was the need for revascularization of the target lesion (4% in both groups; P = 0.766).

Conclusion: Treatment with folic acid does not decrease the rate of restenosis and need for revascularization of the target lesion after stent-percutaneous coronary angioplasty.