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GISSI-HF rosuvastatine study, 2008	TRC7346
[NCT00336336]	download pdf: rosuvastatin | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	low-dose rosuvastatin 10 mg daily
Control treatment	placebo
Concomittant treatment	factorial design

Patients

Patients	Patients with NYHA classes II to IV heart failure, whatever the cause and the LVEF and already receiving optimized recommended therapy with no clear indication or contraindication to cholesterollowering therapy
Inclusion criteria	men and women; aged 18 years or older; symptomatic heart failure NYHA II�IV, treated according to European Society of Cardiology (ESC) guidelines (for patients with LVEF >40%, at least one hospital admission for congestive heart failure in the preceding year)
Exclusion criteria	any noncardiac comorbidity incompatible with a sufficiently long follow-up; acute coronary syndrome or a revascularisation procedure within 1 month before; planned cardiac surgery, expected to be done within 3 months after randomisation; significant liver disease; serum creatinine concentration greater than 221 �mol/L; alanine and aspartate transaminase > 1�5x UNL; creatine phosphokinase >UNL; hypersensitivity to study treatment;
Baseline characteristics	Age (year) 68  Women (%) 22  NYHA II 62  NYHA III 34.5  NYHA IV 2  LVEF (%) 33  Previous MI 32  Diabetes (%) 26  Previous stroke 4  Ischaemic cause (%) 39.5  Dilatative cause (%) 34  Hypertensive cause 17.5  ACE inhibitors 77  ARBs 18  � blockers 62  Spironolactone 40  Diuretic drugs 90  Digitalis 40  Oral anticoagulant drugs 29.5  Nitrates 32

Method and design

Randomized effectives	2314 / 2317 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	3.9y median (IQR 3-4.4)
Lost to follow-up	n=4
Number of centre	326
Geographic area	Italy
Hypothesis	Superiority
Primary endpoint	death and death+hospitalization

Results

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

Endpoint	Events (%)		Relative Risk	95% CI
	Studied treat.	Control treat.
Patients who died of cardiovascular reasons	478 / 2314 (20,7%)	488 / 2317 (21,1%)	0,98	[0,88;1,10]
Patients who had an SCD	220 / 2314 (9,5%)	196 / 2317 (8,5%)	1,12	[0,94;1,35]
Patients admitted	1278 / 2314 (55,2%)	1286 / 2317 (55,5%)	1,00	[0,94;1,05]
Patients admitted for a cardiovascular reason	1033 / 2314 (44,6%)	1060 / 2317 (45,7%)	0,98	[0,92;1,04]
Patients admitted for heart failure	629 / 2314 (27,2%)	634 / 2317 (27,4%)	0,99	[0,90;1,09]
Patients who died of a cardiovascular cause or were admitted for any reason	1417 / 2314 (61,2%)	1385 / 2317 (59,8%)	1,02	[0,98;1,07]
Patients with fatal and non-fatal MI	61 / 2314 (2,6%)	70 / 2317 (3,0%)	0,87	[0,62;1,22]
Patients with fatal and non-fatal stroke	82 / 2314 (3,5%)	66 / 2317 (2,8%)	1,24	[0,90;1,71]
Total mortality	657 / 2314 (28,4%)	644 / 2317 (27,8%)	1,02	[0,93;1,12]
death by Acute myocardial infarction	10 / 2314 (0,4%)	15 / 2317 (0,6%)	0,67	[0,30;1,48]
death by Worsening of heart failure	203 / 2314 (8,8%)	231 / 2317 (10,0%)	0,88	[0,74;1,05]
death by Presumed arrhythmic	198 / 2314 (8,6%)	182 / 2317 (7,9%)	1,09	[0,90;1,32]
fatal Stroke	38 / 2314 (1,6%)	29 / 2317 (1,3%)	1,31	[0,81;2,12]
Other cardiovascular death	29 / 2314 (1,3%)	31 / 2317 (1,3%)	0,94	[0,57;1,55]
death by Neoplasia	81 / 2314 (3,5%)	75 / 2317 (3,2%)	1,08	[0,79;1,47]
Other non-cardiovascular death	75 / 2314 (3,2%)	55 / 2317 (2,4%)	1,37	[0,97;1,92]
Not known cause of death	23 / 2314 (1,0%)	26 / 2317 (1,1%)	0,89	[0,51;1,55]

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]

new-onset diabetes

225 / 1660
215 / 1718
1,08 [0,91;1,29]

All cause death

657 / 2314
644 / 2317
1,02 [0,93;1,12]

Non vascular death

156 / 2314
130 / 2317
1,20 [0,96;1,51]

Cardiovascular death

478 / 2314
488 / 2317
0,98 [0,88;1,10]

Fatal MI

10 / 2314
15 / 2317
0,67 [0,30;1,48]

stroke (fatal and non fatal)

82 / 2314
66 / 2317
1,24 [0,90;1,71]

cardiovascular events

1033 / 2314
1060 / 2317
0,98 [0,92;1,04]

Fatal stroke

38 / 2314
29 / 2317
classic 1,31 [0,81;2,12]

myocardial infarction (fatal and non fatal)

61 / 2314
70 / 2317
0,87 [0,62;1,22]

Coronary event

61 / 2314
70 / 2317
0,87 [0,62;1,22] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
new-onset diabetes	225 / 1660 (13,6%)	215 / 1718 (12,5%)	1,08	[0,91;1,29]	sub group
stroke (fatal and non fatal)	82 / 2314 (3,5%)	66 / 2317 (2,8%)	1,24	[0,90;1,71]		0
Fatal stroke	38 / 2314 (1,6%)	29 / 2317 (1,3%)	1,31	[0,81;2,12]	fatal Stroke
myocardial infarction (fatal and non fatal)	61 / 2314 (2,6%)	70 / 2317 (3,0%)	0,87	[0,62;1,22]		0
Cardiovascular death	478 / 2314 (20,7%)	488 / 2317 (21,1%)	0,98	[0,88;1,10]	Patients who died of cardiovascular reasons
Coronary event	61 / 2314 (2,6%)	70 / 2317 (3,0%)	0,87	[0,62;1,22]	Patients with fatal and non-fatal MI
Non vascular death	156 / 2314 (6,7%)	130 / 2317 (5,6%)	1,20	[0,96;1,51]
cardiovascular events	1033 / 2314 (44,6%)	1060 / 2317 (45,7%)	0,98	[0,92;1,04]	Patients admitted for a cardiovascular reason	18152
All cause death	657 / 2314 (28,4%)	644 / 2317 (27,8%)	1,02	[0,93;1,12]	Total mortality
Fatal MI	10 / 2314 (0,4%)	15 / 2317 (0,6%)	0,67	[0,30;1,48]	death by Acute myocardial infarction
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 18152: Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni GEffect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.Lancet 2008;372:1231-9 0:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 3.9y median (IQR 3-4.4))
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
new-onset diabetes	13,55%	12,51%	1,0%
stroke (fatal and non fatal)	3,54%	2,85%	0,70%
Fatal stroke	1,64%	1,25%	0,39%
myocardial infarction (fatal and non fatal)	2,64%	3,02%	-0,39%
Cardiovascular death	20,66%	21,06%	-0,40%
Coronary event	2,64%	3,02%	-0,39%
Non vascular death	6,74%	5,61%	1,1%
cardiovascular events	44,64%	45,75%	-1,11%
All cause death	28,39%	27,79%	0,60%
Fatal MI	4,32‰	6,47‰	-0,22%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in heart failure for all type of patients

Reference(s)

TrialResults-center ID	TRC7346
Trials register #	NCT00336336

• Tavazzi L, Tognoni G, Franzosi MG, Latini R, Maggioni AP, Marchioli R, Nicolosi GL, Porcu M. Rationale and design of the GISSI heart failure trial: a large trial to assess the effects of n-3 polyunsaturated fatty acids and rosuvastatin in symptomatic congestive heart failure.. Eur J Heart Fail 2004 Aug;6:635-41
  Pubmed | Hubmed | Fulltext
• Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.. Lancet 2008;372:1231-9
  Pubmed | Hubmed | Fulltext

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