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. Author manuscript; available in PMC: 2009 May 20.
Published in final edited form as: JAMA. 2008 May 7;299(17):2027–2036. doi: 10.1001/jama.299.17.2027

Table 2.

Relative Risks Of Clinical Outcomes According To Treatment Assignment with Folic acid/Vitamin B6/Vitamin B12 versus Placebo.

Outcome Active N=2721 Placebo N=2721 Relative risk* (95% CI) P value
No of Patients (%)
Combined Major Cardiovascular Disease 406 (14.9) 390 (14.3) 1.03 (0.90–1.19) 0.65
Myocardial Infarction 65 (2.4) 74 (2.7) 0.87 (0.63–1.22) 0.42
Stroke 79 (2.9) 69 (2.5) 1.14 (0.82–1.57) 0.44
 Ischemic 69 (2.5) 62 (2.3) 1.10 (0.78–1.56) 0.57
 Hemorrhagic 10 (0.4) 6 (0.2) 1.65 (0.60–4.53) 0.33
Coronary Revascularization§ 253 (9.3) 255 (9.4) 0.99 (0.83–1.17) 0.87
 Coronary Artery Bypass Grafting|| 87 (3.2) 98 (3.6) 0.88 (0.66–1.17) 0.38
 Percutaneous Coronary Intervention|| 192 (7.1) 177 (6.5) 1.08 (0.88–1.33) 0.46
Cardiovascular death 96 (3.5) 94 (3.5) 1.01 (0.76–1.35) 0.93
Myocardial infarction, stroke, and cardiovascular death 205 (7.5) 211 (7.8) 0.96 (0.80–1.17) 0.72
Total coronary heart disease#| 283 (10.4) 280 (10.3) 1.00 (0.85–1.18) 0.96
Total mortality 250 (9.2) 256 (9.4) 0.97(0.81–1.15) 0.73
*

Estimated from Cox proportional hazards models that adjusted for age and randomized treatment assignment to vitamin E., vitamin C, and beta-carotene.

The primary outcome is defined as a composite endpoint comprising the first of any of these events: non-fatal myocardial infarction, stroke, coronary revascularization procedures (coronary artery bypass grafting or percutaneous coronary intervention), and cardiovascular mortality.

Stroke type was unknown for 1 woman in the placebo group.

§

Composite endpoint comprised of the first coronary artery bypass grafting or percutaneous coronary intervention.

||

Includes all incident coronary artery bypass grafting operations and percutaneous coronary intervention respectively.

#|

Composite endpoint comprised of the first of any of these events: non-fatal myocardial infarction, coronary revascularization procedures (coronary artery bypass grafting or percutaneous coronary intervention), and coronary heart disease death.