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Previous Volume 350:2673-2681 June 24, 2004 Number 26 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Herrmann, H. C. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

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 B₆, 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 B₆, and vitamin B₁₂ after coronary stenting may increase the risk of in-stent restenosis and the need for target-vessel revascularization.

Source Information

From the Kardiologische Praxis, Klinikum Links der Weser, Heart Center, Bremen, Germany (H.L., C.B., K.K., M.N.P., E.S.); Isala Klinieken, Hospital De Weezenlanden, Zwolle, the Netherlands (H.S., G.D., J.-H.E.D.); and Diagram, Zwolle, the Netherlands (J.D.).

Address reprint requests to Dr. Suryapranata at the Department of Cardiology, Isala Klinieken, Hospital De Weezenlanden, Groot Wezeland 20, 8011 JW Zwolle, the Netherlands, or at h.suryapranata{at}diagram-zwolle.nl.

Full Text of this Article

Related Letters:

Folate Therapy and In-Stent Restenosis
Stanger O., Fowler B., Herrmann W., Lange H., Suryapranata H.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:1259-1260, Sep 16, 2004. Correspondence

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