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Meta-Analysis
. 2014 Sep 1;2014(9):CD006870.
doi: 10.1002/14651858.CD006870.pub3.

Statins for acute coronary syndrome

Noah Vale  1 , Alain J Nordmann, Gregory G Schwartz, James de Lemos, Furio Colivicchi, Frank den Hartog, Petr Ostadal, Stella M Macin, Anho H Liem, Edward J Mills, Neera Bhatnagar, Heiner C Bucher, Matthias Briel
Affiliations
Meta-Analysis

Statins for acute coronary syndrome

Noah Vale et al. Cochrane Database Syst Rev. .

Abstract

Background: The early period following the onset of acute coronary syndrome (ACS) represents a critical stage of coronary heart disease, with a high risk of recurrent events and deaths. The short-term effects of early treatment with statins on patient-relevant outcomes in patients suffering from ACS are unclear. This is an update of a review previously published in 2011.

Objectives: To assess the effects, both harms and benefits, of early administered statins in patients with ACS, in terms of mortality and cardiovascular events.

Search methods: We updated the searches of CENTRAL (2013, Issue 3), MEDLINE (Ovid) (1946 to April Week 1 2013), EMBASE (Ovid) (1947 to 2013 Week 14), and CINAHL (EBSCO) (1938 to 2013) on 12 April 2013. We applied no language restrictions. We supplemented the search by contacting experts in the field, by reviewing the reference lists of reviews and editorials on the topic, and by searching trial registries.

Selection criteria: Randomized controlled trials (RCTs) comparing statins with placebo or usual care, with initiation of statin therapy within 14 days following the onset of ACS, follow-up of at least 30 days, and reporting at least one clinical outcome.

Data collection and analysis: Two authors independently assessed risk of bias and extracted data. We calculated risk ratios (RRs) for all outcomes in the treatment and control groups and pooled data using random-effects models.

Main results: Eighteen studies (14,303 patients) compared early statin treatment versus placebo or no treatment in patients with ACS. The new search did not identify any new studies for inclusion. There were some concerns about risk of bias and imprecision of summary estimates. Based on moderate quality evidence, early statin therapy did not decrease the combined primary outcome of death, non-fatal myocardial infarction, and stroke at one month (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.80 to 1.08) or four months (RR 0.93, 95% CI 0.81 to 1.06) of follow-up when compared to placebo or no treatment. There were no statistically significant risk reductions from statins for total death, total myocardial infarction, total stroke, cardiovascular death, revascularization procedures, and acute heart failure at one month or at four months, although there were favorable trends related to statin use for each of these endpoints. Moderate quality evidence suggests that the incidence of unstable angina was significantly reduced at four months following ACS (RR 0.76, 95% CI 0.59 to 0.96). There were nine individuals with myopathy (elevated creatinine kinase levels more than 10 times the upper limit of normal) in statin-treated patients (0.13%) versus one (0.015%) in the control groups. Serious muscle toxicity was mostly limited to patients treated with simvastatin 80 mg.

Authors' conclusions: Based on moderate quality evidence, due to concerns about risk of bias and imprecision, initiation of statin therapy within 14 days following ACS does not reduce death, myocardial infarction, or stroke up to four months, but reduces the occurrence of unstable angina at four months following ACS. Serious side effects were rare.

PubMed Disclaimer

Conflict of interest statement

Dr Vale declared no interests.

Dr Nordmann declared no interests.

Dr Schwartz has received honoraria and grant support from Pfizer.

Dr de Lemos has received honoraria from Merck, Pfizer, Merck/Schering, and Bristol‐Myers Squibb and grant support from Merck and Pfizer. He has also received consulting fees from Astra Zeneca for participation in an endpoint review committee for a product unrelated to the current manuscript.

Dr Colivicchi declared no interests.

Dr den Hartog declared no interests.

Dr Ostadal has received honoraria from Pfizer, Merck, and AstraZeneca and grant support from Novartis.

Dr Macin declared no interests.

Dr Liem has received honoraria from Merck/Schering and Astra Zeneca.

Dr. Mills has received grant support or consulting honoraria from Pfizer, Merck, Janssen, Astra Zeneca, Novartis, and Boehringer Ingelheim.

Mrs Bhatnagar declared no interests.

Dr Bucher has received grant support from Merck and Bristol‐Myers Squibb.

Dr Briel declared no interests.

None of the support or honoraria above were related to research or drugs that are subject of the current meta‐analysis. There was no pharmaceutical industry support for this review.

Figures

1
1
Study flow chart.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
3
3
Funnel plot of comparison: 1 Statins versus control at 1 month, outcome: 1.1 Combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
4
4
Funnel plot of comparison: 2 Statins versus control at 4 months (3 to 6 months), outcome: 2.1 Combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
5
5
Funnel plot of comparison: 3 Statins versus control at 12 months, outcome: 3.1 Combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
1.1
1.1. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 1 Combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
1.2
1.2. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 2 Death from all causes.
1.3
1.3. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 3 Death from cardiovascular causes.
1.4
1.4. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 4 Fatal and non‐fatal myocardial infarction or reinfarction.
1.5
1.5. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 5 Fatal and non‐fatal stroke.
1.6
1.6. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 6 Revascularization procedures (bypass grafts, angioplasty).
1.7
1.7. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 7 Unstable angina.
1.8
1.8. Analysis
Comparison 1 Statins versus control at 1 month, Outcome 8 Acute heart failure.
2.1
2.1. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 1 Combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
2.2
2.2. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 2 Death from all causes.
2.3
2.3. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 3 Death from cardiovascular causes.
2.4
2.4. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 4 Fatal and non‐fatal myocardial infarction or reinfarction.
2.5
2.5. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 5 Fatal and non‐fatal stroke.
2.6
2.6. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 6 Revascularization procedures (bypass grafts, angioplasty).
2.7
2.7. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 7 Unstable angina.
2.8
2.8. Analysis
Comparison 2 Statins versus control at 4 months (3 to 6 months), Outcome 8 Acute heart failure.
3.1
3.1. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 1 Combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
3.2
3.2. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 2 Death from all causes.
3.3
3.3. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 3 Death from cardiovascular causes.
3.4
3.4. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 4 Fatal and non‐fatal myocardial infarction or reinfarction.
3.5
3.5. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 5 Fatal and non‐fatal stroke.
3.6
3.6. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 6 Revascularization procedures (bypass grafts, angioplasty).
3.7
3.7. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 7 Unstable angina.
3.8
3.8. Analysis
Comparison 3 Statins versus control at 12 months, Outcome 8 Acute heart failure.
4.1
4.1. Analysis
Comparison 4 Statins versus control: adverse events, Outcome 1 Rhabdomyolysis.
4.2
4.2. Analysis
Comparison 4 Statins versus control: adverse events, Outcome 2 Elevated CK > 10x upper‐limit of normal.
4.3
4.3. Analysis
Comparison 4 Statins versus control: adverse events, Outcome 3 Elevated ALT > 3x upper‐limit of normal.
5.1
5.1. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 1 Allocation concealment ‐ combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
5.2
5.2. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 2 Blinded patients and caregivers ‐ combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
5.3
5.3. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 3 Blinded assessment ‐ combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths.
5.4
5.4. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 4 Allocation concealment ‐ death from all causes.
5.5
5.5. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 5 Blinded patients and caregivers ‐ death from all causes.
5.6
5.6. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 6 Blinded assessment ‐ death from all causes.
5.7
5.7. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 7 Allocation concealment ‐ unstable angina.
5.8
5.8. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 8 Blinded patients and caregivers ‐ unstable angina.
5.9
5.9. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 9 Blinded assessment ‐ unstable angina.
5.10
5.10. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 10 Death from all causes including PRINCESS.
5.11
5.11. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 11 Fatal and non‐fatal myocardial infarction or reinfarction including PRINCESS.
5.12
5.12. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 12 Fatal and non‐fatal stroke including PRINCESS.
5.13
5.13. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 13 Unstable angina including PRINCESS.
5.14
5.14. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 14 Initiation of statins.
5.15
5.15. Analysis
Comparison 5 Statins versus control at 4 months: sensitivity analyses, Outcome 15 Types of statins.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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MIRACL 2001 {published and unpublished data}
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OACIS‐LIPID 2008 {published data only (unpublished sought but not used)}
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PACT 2004 {published and unpublished data}
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PRINCESS 2004 {unpublished data only}
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PTT 2002 {published and unpublished data}
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RECIFE 1999 {published and unpublished data}
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Ren 2009 {published data only}
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Sakamoto 2005 {published data only (unpublished sought but not used)}
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References to studies excluded from this review

Akasaka 2012 {published data only}
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Barderas 2009 {published data only}
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Cannon 2004a {published data only}
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Chi 2007 {published data only}
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Correia 2002 {published data only}
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FLAME 2006 {published data only}
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Ge 2010 {published data only}
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Gómez‐Doblas 2006 {published data only}
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Gómez‐Hernández 2008 {published data only}
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Guazzi 2007 {published data only}
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Hall 2009 {published data only}
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He 2011 {published data only}
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Hiro 2009 {published data only}
    1. Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, et al. Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN‐ACS [Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome] Study). Journal of the American College of Cardiology 2009;54(4):293–302. - PubMed
Hiro 2009a {published data only}
    1. Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, et al. Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN‐ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). Journal of the American College of Cardiology 2009;54(4):293‐302. - PubMed
Hiro 2010 {published data only}
    1. Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, et al. Diabetes mellitus is a major negative determinant of coronary plaque regression during statin therapy in patients with acute coronary syndrome‐‐serial intravascular ultrasound observations from the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome Trial (the JAPAN‐ACS Trial). Circulation Journal 2010;74:1165‐74. - PubMed
Kanadasi 2006 {published data only (unpublished sought but not used)}
    1. Kanadaşı M, Çaylı M, Demirtaş M, Inal T, Demir M, Koç M, et al. The effect of early statin treatment on inflammation and cardiac events in acute coronary syndrome patients with low‐density lipoprotein cholesterol. Heart and Vessels 2006;21(5):291–7. - PubMed
Kashima 2009 {published data only}
    1. Kashima Y, Izawa A, Aizawa K, Koshikawa M, Kasai H, Tomita T, et al. Rationale and design of assessment of lipophilic vs. hydrophilic statin therapy in acute myocardial infarction (the ALPS‐AMI) study. Journal of Cardiology 2009;54(1):76–9. - PubMed
Kuznetsova 2010 {published data only}
    1. Kuznetsova MA, Vaulin NA, Masenko VP, Gratsianskii NA. Non‐ST‐elevation acute coronary syndrome. Comparison of effects of atorvastatin and rosuvastatin on blood levels of lipids and markers of inflammation. Kardiologiia 2010;50:21‐5. - PubMed
Lablanche 2008 {published data only}
    1. Lablanche JM, Danchin N, Farnier M, Tedgui A, Vicaut E, Alonso J, et al. Effects of rosuvastatin and atorvastatin on the apolipoprotein B/apolipoprotein A‐1 ratio in patients with an acute coronary syndrome: the CENTAURUS trial design. Archives of Cardiovascular Diseases 2008;101(6):399–406. - PubMed
LAVA 2005 {published data only}
    1. Wojakowski W, Michalowska A, Majka M, Maslankiewicz K, Wyderka R, Krol M, et al. Early treatment with fluvastatin enhances the mobilization of CD34+, CD117+, CXCR4+, C‐met+ stem cells into peripheral blood in patients with acute myocardial infarction: LAVA trial. Journal of the American College of Cardiology 2005;45(Suppl A, February):A197‐8.
Lemos 2005 {published data only}
    1. Lemos PA, Feyter PJ, Serruys PW, Saia F, Arampatzis CA, Disco C, et al. Fluvastatin reduces the 4‐year cardiac risk in patients with multivessel disease. International Journal of Cardiology 2005;98(3):479–86. - PubMed
Leone 2008 {published data only}
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Li 2005 {published data only}
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Nakamura 2008 {published data only}
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Shah 2007 {published data only}
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Tousoulis 2006b {published data only}
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References to other published versions of this review

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