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QUESTION: In patients having percutaneous coronary intervention (PCI), does homocysteine lowering treatment with folic acid, vitamin B12, and vitamin B6 reduce adverse coronary outcomes?
Design
Randomised (unclear allocation concealment*), blinded (clinicians, patients, and outcome assessors),* placebo controlled trial with 12 months of follow up.
Setting
A university hospital in Bern, Switzerland.
Patients
553 patients (mean age 63 y, 80% men) who received angioplasty to treat at least 1 significant coronary stenosis (≥50%). Exclusion criteria were unstable angina, myocardial infarction (MI) within the past 2 weeks, renal insufficiency, or receipt of vitamin supplements. Follow up was 83%; all patients were included in the analysis.
Intervention
Patients were allocated to homocysteine lowering treatment with folic acid, 1 mg/day; vitamin B12, …