Treatment with B vitamins did not lower the risk of recurrent cardiovascular disease after acute myocardial infarction. A harmful effect from combined B vitamin treatment was suggested. Such treatment should therefore not be recommended. (ClinicalTrials.gov number, NCT00266487.).
Context Observational studies have reported associations between circulating total homocysteine concentration and risk of cardiovascular disease. Oral administration of folic acid and vitamin B 12 can lower plasma total homocysteine levels.Objective To assess the effect of treatment with folic acid and vitamin B 12 and the effect of treatment with vitamin B 6 as secondary prevention in patients with coronary artery disease or aortic valve stenosis.Design, Setting, and Participants Randomized, double-blind controlled trial conducted in the 2 university hospitals in western Norway in 1999-2006. A total of 3096 adult participants undergoing coronary angiography (20.5% female; mean age, 61.7 years) were randomized. At baseline, 59.3% had double-or triple-vessel disease, 83.7% had stable angina pectoris, and 14.9% had acute coronary syndromes.Interventions Using a 2ϫ2 factorial design, participants were randomly assigned to 1 of 4 groups receiving daily oral treatment with folic acid, 0.8 mg, plus vitamin B 12 , 0.4 mg, plus vitamin B 6 , 40 mg (n=772); folic acid plus vitamin B 12 (n=772); vitamin B 6 alone (n=772); or placebo (n=780).
Main Outcome MeasuresThe primary end point was a composite of all-cause death, nonfatal acute myocardial infarction, acute hospitalization for unstable angina pectoris, and nonfatal thromboembolic stroke.
ResultsMean plasma total homocysteine concentration was reduced by 30% after 1 year of treatment in the groups receiving folic acid and vitamin B 12 . The trial was terminated early because of concern among participants due to preliminary results from a contemporaneous Norwegian trial suggesting adverse effects from the intervention. During a median 38 months of follow-up, the primary end point was experienced by a total of 422 participants (13.7%): 219 participants (14.2%) receiving folic acid/vitamin B 12 vs 203 (13.1%) not receiving such treatment (hazard ratio, 1.09; 95% confidence interval, 0.90-1.32; P=.36) and 200 participants (13.0%) receiving vitamin B 6 vs 222 (14.3%) not receiving vitamin B 6 (hazard ratio, 0.90; 95% confidence interval, 0.74-1.09; P=.28).Conclusions This trial did not find an effect of treatment with folic acid/vitamin B 12 or vitamin B 6 on total mortality or cardiovascular events. Our findings do not support the use of B vitamins as secondary prevention in patients with coronary artery disease.
In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).
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