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.