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).


CONCLUSIONS
Treatment with folic acid does not decrease the rate of restenosis and need for revascularization of the target lesion after stent-percutaneous coronary angioplasty.
Namazi
Mohammad-Hassan
MH
Department of Cardiology, Cardiovascular Research Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.
Motamedi
Mohammad-Reza
MR
Safi
Morteza
M
Vakili
Hossein
H
Saadat
Habibollah
H
Nazari
Neshat
N
D017023:Coronary Angiography / Q000009:adverse effects*; D023903:Coronary Restenosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005492:Folic Acid / Q000627:therapeutic use*; D006710:Homocysteine / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents / Q000009:adverse effects*
D006710:Homocysteine; D005492:Folic Acid