See also:

WAFACS study, 2008	TRC8813
[NCT00000541]	download pdf: folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	folic acid 2.5mg, vitamin B6 50mg, and vitamin B12 1mg daily
Control treatment	placebo

Patients

Patients	women aged 42 years or older, with either a history of CVD or 3 or more coronary risk factors
Inclusion criteria	40 years or older, postmenopausal or had no intention of becoming pregnant, and had a reported history of CVD or had at least 3 cardiac risk factors;
Exclusion criteria	history of cancer (excluding nonmelanoma skin cancer) within the past 10 years, any serious non-CVD illness, or were currently using warfarin or other anticoagulants
Baseline characteristics	Age (yr) 62.8 y  Male sex 0%  BMI NA  diabetes (%) 21%

Method and design

Randomized effectives	2721 / 2721 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	7.3 y
Geographic area	US
Hypothesis	Superiority
Primary endpoint	cardiovascular events

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
	Studied treat.	Control treat.
Combined major cardiovascular disease	406 / 2721 (14,9%)	390 / 2721 (14,3%)	1,04	[0,92;1,18]
Myocardial infarction	65 / 2721 (2,4%)	74 / 2721 (2,7%)	0,88	[0,63;1,22]
Stroke	79 / 2721 (2,9%)	69 / 2721 (2,5%)	1,14	[0,83;1,57]
Ischemic stroke	69 / 2721 (2,5%)	62 / 2721 (2,3%)	1,11	[0,79;1,56]
Hemorrhagic stroke	10 / 2721 (0,4%)	6 / 2721 (0,2%)	1,67	[0,61;4,58]
Coronary revascularization	253 / 2721 (9,3%)	255 / 2721 (9,4%)	0,99	[0,84;1,17]
CABG	87 / 2721 (3,2%)	98 / 2721 (3,6%)	0,89	[0,67;1,18]
PCI	192 / 2721 (7,1%)	177 / 2721 (6,5%)	1,08	[0,89;1,32]
Cardiovascular death	96 / 2721 (3,5%)	94 / 2721 (3,5%)	1,02	[0,77;1,35]
Myocardial infarction, stroke, cardiovascular death	205 / 2721 (7,5%)	211 / 2721 (7,8%)	0,97	[0,81;1,17]
Total coronary heart disease	283 / 2721 (10,4%)	280 / 2721 (10,3%)	1,01	[0,86;1,18]
Total mortality	250 / 2721 (9,2%)	256 / 2721 (9,4%)	0,98	[0,83;1,15]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Non fatal MI

65 / 2721
74 / 2721
0,88 [0,63;1,22]

Cardiovascular death

96 / 2721
94 / 2721
1,02 [0,77;1,35]

cardiac death

283 / 2721
280 / 2721
1,01 [0,86;1,18]

All cause death

250 / 2721
256 / 2721
0,98 [0,83;1,15]

cardiovascular events

406 / 2721
390 / 2721
1,04 [0,92;1,18]

stroke (fatal and non fatal)

79 / 2721
69 / 2721
1,14 [0,83;1,57] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Non fatal MI	65 / 2721 (2,4%)	74 / 2721 (2,7%)	0,88	[0,63;1,22]	Myocardial infarction	0
Cardiovascular death	96 / 2721 (3,5%)	94 / 2721 (3,5%)	1,02	[0,77;1,35]	Cardiovascular death	0
All cause death	250 / 2721 (9,2%)	256 / 2721 (9,4%)	0,98	[0,83;1,15]	Total mortality	0
cardiovascular events	406 / 2721 (14,9%)	390 / 2721 (14,3%)	1,04	[0,92;1,18]	Combined major cardiovascular disease	0
stroke (fatal and non fatal)	79 / 2721 (2,9%)	69 / 2721 (2,5%)	1,14	[0,83;1,57]	Stroke	0
cardiac death	283 / 2721 (10,4%)	280 / 2721 (10,3%)	1,01	[0,86;1,18]	Total coronary heart disease	0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 7.3 y)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Non fatal MI	2,39%	2,72%	-0,33%
Cardiovascular death	3,53%	3,45%	0,07%
All cause death	9,19%	9,41%	-0,22%
cardiovascular events	14,92%	14,33%	0,59%
stroke (fatal and non fatal)	2,90%	2,54%	0,37%
cardiac death	10,40%	10,29%	0,11%

Meta-analysis of all similar trials:

plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC8813
Trials register #	NCT00000541

• Albert CM, Cook NR, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE. Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial.. JAMA 2008 May 7;299:2027-36
  Pubmed | Hubmed | Fulltext
• Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effect of homocysteine-lowering treatment with folic Acid and B vitamins on risk of type 2 diabetes in women: a randomized, controlled trial.. Diabetes 2009;58:1921-8
  Pubmed | Hubmed | Fulltext

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