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Schnyder G, Roffi M, Flammer Y, Pin R, Hess OM. Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Clinical Outcome After Percutaneous Coronary Intervention: The Swiss Heart Study: A Randomized Controlled Trial. JAMA. 2002;288(8):973–979. doi:10.1001/jama.288.8.973
Author Affiliations: Division of Cardiology, Swiss Cardiovascular Center Bern, University Hospital, Bern, Switzerland (Drs Flammer, Pin, and Hess); Department of Cardiovascular Medicine/F25, The Cleveland Clinic Foundation, Cleveland, Ohio (Dr Roffi); and the Division of Cardiology, UCSD Medical Center, University of California, San Diego (Dr Schnyder).
Context Plasma homocysteine level has been recognized as an important cardiovascular
risk factor that predicts adverse cardiac events in patients with established
coronary atherosclerosis and influences restenosis rate after percutaneous
Objective To evaluate the effect of homocysteine-lowering therapy on clinical
outcome after percutaneous coronary intervention.
Design, Setting, and Participants Randomized, double-blind placebo-controlled trial involving 553 patients
referred to the University Hospital in Bern, Switzerland, from May 1998 to
April 1999 and enrolled after successful angioplasty of at least 1 significant
coronary stenosis (≥50%).
Intervention Participants were randomly assigned to receive a combination of folic
acid (1 mg/d), vitamin B12 (cyanocobalamin, 400 µg/d), and
vitamin B6 (pyridoxine hydrochloride, 10 mg/d) (n = 272) or placebo
(n = 281) for 6 months.
Main Outcome Measure Composite end point of major adverse events defined as death, nonfatal
myocardial infarction, and need for repeat revascularization, evaluated at
6 months and 1 year.
Results After a mean (SD) follow-up of 11 (3) months, the composite end point
was significantly lower at 1 year in patients treated with homocysteine-lowering
therapy (15.4% vs 22.8%; relative risk [RR], 0.68; 95% confidence interval
[CI], 0.48-0.96; P = .03), primarily due to a reduced
rate of target lesion revascularization (9.9% vs 16.0%; RR, 0.62; 95% CI,
0.40-0.97; P = .03). A nonsignificant trend was seen
toward fewer deaths (1.5% vs 2.8%; RR, 0.54; 95% CI, 0.16-1.70; P = .27) and nonfatal myocardial infarctions (2.6% vs 4.3%; RR, 0.60;
95% CI, 0.24-1.51; P = .27) with homocysteine-lowering
therapy. These findings remained unchanged after adjustment for potential
Conclusion Homocysteine-lowering therapy with folic acid, vitamin B12,
and vitamin B6 significantly decreases the incidence of major adverse
events after percutaneous coronary intervention.
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