See also:

GOES (Liem) study, 2003	TRC9990
	download pdf: folic acid | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	folic acid 0.5 mg per day
Control treatment	usual care

Patients

Patients	patients with stable coronary artery disease
Exclusion criteria	age below 18 years, history of low vitamin B12 level, treatment for hyperhomocysteinemia, severe renal failure, or any other treatment for renal disease, known hepatic disease, signs and symptoms of severe heart failure (New York Heart Association functional class IV) or any other serious illness that would exclude follow-up time of at least three years
Baseline characteristics	Age (yr) 65 y  Male sex 78%  BMI 27.0

Method and design

Randomized effectives	300 / 293 (studied vs. control)
Design	Parallel groups
Blinding	open
Follow-up duration	24 months
Number of centre	single center
Geographic area	The Netherlands
Hypothesis	Superiority
Primary endpoint	CV events

Results

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

All cause death

12 / 300
14 / 293
0,84 [0,39;1,78]

Non fatal MI

3 / 300
4 / 293
classic 0,73 [0,17;3,24]

cardiovascular events

37 / 300
33 / 293
1,10 [0,70;1,70]

Cardiovascular death

7 / 300
9 / 293
classic 0,76 [0,29;2,01]

stroke (fatal and non fatal)

4 / 300
3 / 293
classic 1,30 [0,29;5,77]

Non fatal MI

3 / 300
4 / 293
classic 0,73 [0,17;3,24] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
All cause death	12 / 300 (4,0%)	14 / 293 (4,8%)	0,84	[0,39;1,78]		11305
Non fatal MI	3 / 300 (1,0%)	4 / 293 (1,4%)	0,73	[0,17;3,24]		11305
cardiovascular events	37 / 300 (12,3%)	33 / 293 (11,3%)	1,10	[0,70;1,70]		11309
Non fatal MI	3 / 300 (1,0%)	4 / 293 (1,4%)	0,73	[0,17;3,24]		11309
Cardiovascular death	7 / 300 (2,3%)	9 / 293 (3,1%)	0,76	[0,29;2,01]		11309
stroke (fatal and non fatal)	4 / 300 (1,3%)	3 / 293 (1,0%)	1,30	[0,29;5,77]	CVA/TIA	11309
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 11305: Mart�-Carvajal AJ, Sol� I, Lathyris D, Salanti GHomocysteine lowering interventions for preventing cardiovascular events.Cochrane Database Syst Rev 2009 Oct 7;:CD006612 11309: Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, Jukema JW, van Veldhuisen DJSecondary prevention with folic acid: effects on clinical outcomes.J Am Coll Cardiol 2003;41:2105-13

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 24 months)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
All cause death	4,00%	4,78%	-0,78%
Non fatal MI	1,00%	1,37%	-0,37%
cardiovascular events	12,33%	11,26%	1,1%
Non fatal MI	1,00%	1,37%	-0,37%
Cardiovascular death	2,33%	3,07%	-0,74%
stroke (fatal and non fatal)	1,33%	1,02%	0,31%

Meta-analysis of all similar trials:

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

Reference(s)

TrialResults-center ID	TRC9990
Trials register #	NA

• Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, Jukema JW, van Veldhuisen DJ. Secondary prevention with folic acid: effects on clinical outcomes.. J Am Coll Cardiol 2003;41:2105-13
  Pubmed | Hubmed | Fulltext
• Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, Jukema JW, van Veldhuisen DJ. Secondary prevention with folic acid: results of the Goes extension study.. Heart 2005;91:1213-4 - 10.1136/hrt.2004.035030
  Pubmed | Hubmed | Fulltext

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