TY - JOUR
T1 - Folate therapy and in-stent restenosis after coronary stenting
AU - Lange, Helmut
AU - Suryapranata, Harry
AU - De Luca, Giuseppe
AU - Börner, Caspar
AU - Dille, Joep
AU - Kallmayer, Klaus
AU - Pasalary, M. Noor
AU - Scherer, Eberhard
AU - Dambrink, Jan Henk E.
PY - 2004/6/24
Y1 - 2004/6/24
N2 - BACKGROUND: Vitamin therapy to lower homocysteine levels has recently been recommended for the prevention of restenosis after coronary angioplasty. We tested the effect of a combination of folic acid, vitamin B6, and vitamin B12 (referred to as folate therapy) on the risk of angiographic restenosis after coronary-stent placement in a double-blind, multicenter trial. METHODS: A total of 636 patients who had undergone successful coronary stenting were randomly assigned to receive 1 mg of folic acid, 5 mg of vitamin B6, and 1 mg of vitamin B12 intravenously, followed by daily oral doses of 1.2 mg of folic acid, 48 mg of vitamin B 6, and 60 μg of vitamin B12 for six months, or to receive placebo. The angiographic end points (minimal luminal diameter, late loss, and restenosis rate) were assessed at six months by means of quantitative coronary angiography. RESULTS: At follow-up, the mean (±SD) minimal luminal diameter was significantly smaller in the folate group than in the placebo group (1.59±0.62 mm vs. 1.74±0.64 mm, P=0.008), and the extent of late luminal loss was greater (0.90±0.55 mm vs. 0.76±0.58 mm, P=0.004). The restenosis rate was higher in the folate group than in the placebo group (34.5 percent vs. 26.5 percent, P=0.05), and a higher percentage of patients in the folate group required repeated target-vessel revascularization (15.8 percent vs. 10.6 percent, P=0.05). Folate therapy had adverse effects on the risk of restenosis in all subgroups except for women, patients with diabetes, and patients with markedly elevated homocysteine levels (15 μmol per liter or more) at baseline. CONCLUSIONS: Contrary to previous findings, the administration of folate, vitamin B 6, and vitamin B12 after coronary stenting may increase the risk of in-stent restenosis and the need for target-vessel revascularization.
AB - BACKGROUND: Vitamin therapy to lower homocysteine levels has recently been recommended for the prevention of restenosis after coronary angioplasty. We tested the effect of a combination of folic acid, vitamin B6, and vitamin B12 (referred to as folate therapy) on the risk of angiographic restenosis after coronary-stent placement in a double-blind, multicenter trial. METHODS: A total of 636 patients who had undergone successful coronary stenting were randomly assigned to receive 1 mg of folic acid, 5 mg of vitamin B6, and 1 mg of vitamin B12 intravenously, followed by daily oral doses of 1.2 mg of folic acid, 48 mg of vitamin B 6, and 60 μg of vitamin B12 for six months, or to receive placebo. The angiographic end points (minimal luminal diameter, late loss, and restenosis rate) were assessed at six months by means of quantitative coronary angiography. RESULTS: At follow-up, the mean (±SD) minimal luminal diameter was significantly smaller in the folate group than in the placebo group (1.59±0.62 mm vs. 1.74±0.64 mm, P=0.008), and the extent of late luminal loss was greater (0.90±0.55 mm vs. 0.76±0.58 mm, P=0.004). The restenosis rate was higher in the folate group than in the placebo group (34.5 percent vs. 26.5 percent, P=0.05), and a higher percentage of patients in the folate group required repeated target-vessel revascularization (15.8 percent vs. 10.6 percent, P=0.05). Folate therapy had adverse effects on the risk of restenosis in all subgroups except for women, patients with diabetes, and patients with markedly elevated homocysteine levels (15 μmol per liter or more) at baseline. CONCLUSIONS: Contrary to previous findings, the administration of folate, vitamin B 6, and vitamin B12 after coronary stenting may increase the risk of in-stent restenosis and the need for target-vessel revascularization.
UR - http://www.scopus.com/inward/record.url?scp=2942752021&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa032845
DO - 10.1056/NEJMoa032845
M3 - Article
SN - 0028-4793
VL - 350
SP - 2673
EP - 2681
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 26
ER -