Drug-eluting stents versus bare-metal stents for acute coronary syndrome
- PMID: 28832903
- PMCID: PMC6483499
- DOI: 10.1002/14651858.CD012481.pub2
Drug-eluting stents versus bare-metal stents for acute coronary syndrome
Abstract
Background: Approximately 3.7 million people died from acute coronary syndrome worldwide in 2012. Acute coronary syndrome, also known as myocardial infarction or unstable angina pectoris, is caused by a sudden blockage of the blood supplied to the heart muscle. Percutaneous coronary intervention is often used for acute coronary syndrome, but previous systematic reviews on the effects of drug-eluting stents compared with bare-metal stents have shown conflicting results with regard to myocardial infarction; have not fully taken account of the risk of random and systematic errors; and have not included all relevant randomised clinical trials.
Objectives: To assess the benefits and harms of drug-eluting stents versus bare-metal stents in people with acute coronary syndrome.
Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, SCI-EXPANDED, and BIOSIS from their inception to January 2017. We also searched two clinical trials registers, the European Medicines Agency and the US Food and Drug Administration databases, and pharmaceutical company websites. In addition, we searched the reference lists of review articles and relevant trials.
Selection criteria: Randomised clinical trials assessing the effects of drug-eluting stents versus bare-metal stents for acute coronary syndrome. We included trials irrespective of publication type, status, date, or language.
Data collection and analysis: We followed our published protocol and the methodological recommendations of Cochrane. Two review authors independently extracted data. We assessed the risks of systematic error by bias domains. We conducted Trial Sequential Analyses to control the risks of random errors. Our primary outcomes were all-cause mortality, major cardiovascular events, serious adverse events, and quality of life. Our secondary outcomes were angina, cardiovascular mortality, and myocardial infarction. Our primary assessment time point was at maximum follow-up. We assessed the quality of the evidence by the GRADE approach.
Main results: We included 25 trials randomising a total of 12,503 participants. All trials were at high risk of bias, and the quality of evidence according to GRADE was low to very low. We included 22 trials where the participants presented with ST-elevation myocardial infarction, 1 trial where participants presented with non-ST-elevation myocardial infarction, and 2 trials where participants presented with a mix of acute coronary syndromes.Meta-analyses at maximum follow-up showed no evidence of a difference when comparing drug-eluting stents with bare-metal stents on the risk of all-cause mortality or major cardiovascular events. The absolute risk of death was 6.97% in the drug-eluting stents group compared with 7.74% in the bare-metal stents group based on the risk ratio (RR) of 0.90 (95% confidence interval (CI) 0.78 to 1.03, 11,250 participants, 21 trials/22 comparisons, low-quality evidence). The absolute risk of a major cardiovascular event was 6.36% in the drug-eluting stents group compared with 6.63% in the bare-metal stents group based on the RR of 0.96 (95% CI 0.83 to 1.11, 10,939 participants, 19 trials/20 comparisons, very low-quality evidence). The results of Trial Sequential Analysis showed that we did not have sufficient information to confirm or reject our anticipated risk ratio reduction of 10% on either all-cause mortality or major cardiovascular events at maximum follow-up.Meta-analyses at maximum follow-up showed evidence of a benefit when comparing drug-eluting stents with bare-metal stents on the risk of a serious adverse event. The absolute risk of a serious adverse event was 18.04% in the drug-eluting stents group compared with 23.01% in the bare-metal stents group based on the RR of 0.80 (95% CI 0.74 to 0.86, 11,724 participants, 22 trials/23 comparisons, low-quality evidence), and Trial Sequential Analysis confirmed this result. When assessing each specific type of adverse event included in the serious adverse event outcome separately, the majority of the events were target vessel revascularisation. When target vessel revascularisation was analysed separately, meta-analysis showed evidence of a benefit of drug-eluting stents, and Trial Sequential Analysis confirmed this result.Meta-analyses at maximum follow-up showed no evidence of a difference when comparing drug-eluting stents with bare-metal stents on the risk of cardiovascular mortality (RR 0.91, 95% CI 0.76 to 1.09, 9248 participants, 14 trials/15 comparisons, very low-quality evidence) or myocardial infarction (RR 0.98, 95% CI 0.82 to 1.18, 10,217 participants, 18 trials/19 comparisons, very low-quality evidence). The results of the Trial Sequential Analysis showed that we had insufficient information to confirm or reject our anticipated risk ratio reduction of 10% on cardiovascular mortality and myocardial infarction.No trials reported results on quality of life or angina.
Authors' conclusions: The current evidence suggests that drug-eluting stents may lead to fewer serious adverse events compared with bare-metal stents without increasing the risk of all-cause mortality or major cardiovascular events. However, our Trial Sequential Analysis showed that there currently was not enough information to assess a risk ratio reduction of 10% for all-cause mortality, major cardiovascular events, cardiovascular mortality, or myocardial infarction, and there were no data on quality of life or angina. The evidence in this review was of low to very low quality, and the true result may depart substantially from the results presented in this review.More randomised clinical trials with low risk of bias and low risks of random errors are needed if the benefits and harms of drug-eluting stents for acute coronary syndrome are to be assessed properly. More data are needed on the outcomes all-cause mortality, major cardiovascular events, quality of life, and angina to reduce the risk of random error.
Conflict of interest statement
The performance of this review is free of any real or perceived bias introduced by receipt of any benefit in cash or kind, on any subsidy derived from any source that may have or be perceived to have an interest in the outcomes of this review.
Joshua Feinberg (JF): no conflict of interest.
Emil Eik Nielsen (EEN): no conflict of interest.
Janette Greenhalgh (JG): no conflict of interest.
Juliet Hounsome (JH): no conflict of interest.
Naqash J Sethi (NS): no conflict of interest.
Sanam Safi (SS): no conflict of interest.
Christian Gluud (CG): member of the Copenhagen Trial Unit task force for developing Trial Sequential Analysis methods, manuals, and software.
Janus C Jakobsen (JCJ): no conflict of interest.
Figures
Comment in
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Cochrane Corner: drug-eluting stents versus bare-metal stents for acute coronary syndrome.Heart. 2018 Dec;104(23):1895-1897. doi: 10.1136/heartjnl-2017-312931. Epub 2018 May 14. Heart. 2018. PMID: 29760240 No abstract available.
References
References to studies included in this review
COMFORTABLE 2012 {published data only}
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DEB‐AMI 2012 {published data only}
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DEDICATION 2008 {published data only}
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De Ribamar Costa 2012 {published data only}
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DEVINE 2007 {published data only}
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Diaz 2007 {published data only}
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ELISA‐3 2016 {published data only}
EXAMINATION 2012 {published data only}
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FIBISTEMI 2007 {published data only}
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GRACIA‐3 2010 {published data only}
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HAAMU‐STENT 2006 {published data only}
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HORIZONS‐AMI 2009 {published data only}
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König 2007 {published data only}
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- König A, Leibig M, Rieber J, Schiele TM, Theisen K, Siebert U, et al. Randomized comparison of dexamethasone-eluting stents with bare metal stent implantation in patients with acute coronary syndrome: serial angiographic and sonographic analysis. American Heart Journal 2007;153(6):979.e1–8. - PubMed
Mission 2008 {published data only}
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- Atary JZ, Hoeven BL, Liem SS, Jukema JW, Bom JG, Atsma DE, et al. Three-year outcome of sirolimus-eluting versus bare-metal stents for the treatment of ST-segment elevation myocardial infarction (from the MISSION! Intervention Study). American Journal of Cardiology 2010;106(1):4-12. - PubMed
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MULTISTRATEGY 2008 {published data only}
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OCTAMI 2010 {published data only}
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PASEO 2009a {published data only}
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PASSION 2006 {published data only}
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SELECTION 2007 {published data only}
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SESAMI 2007 {published data only}
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Steinwender 2008 {published data only}
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- Steinwender C, Hofmann R, Kypta A, Kammler J, Kerschner K, Grund M, et al. In-stent restenosis in bare metal stents versus sirolimus-eluting stents after primary coronary intervention for acute myocardial infarction and subsequent transcoronary transplantation of autologous stem cells. Clinical Cardiology 2008;31(8):356-9. - PMC - PubMed
Strozzi 2007 {published data only}
Typhoon 2006 {published data only}
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- Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. New England Journal of Medicine 2006;355(11):1093-104. - PubMed
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References to studies excluded from this review
ACUITY 2006 {published data only}
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- Stone GW, Mclaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, et al. Bivalirudin for patients with acute coronary syndromes. New England Journal of Medicine 2006;355:2203-16. - PubMed
BARRICADE 2011 {published data only}
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DESSOLVE‐1 2011 {published data only}
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- Sakamoto K, Waseda K, Yock PG, Honda Y, Wijns W, Ormiston J, et al. Arterial response to sirolimus eluting stents with bioabsorbable polymer: First IVUS Report from the DESSOLVE-I FIM Trial. Journal of the American College of Cardiology 2011;58(20, Suppl B):B32.
Gioia 2006 {published data only}
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Halkin 2006 {published data only}
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Han 2006 {published data only}
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Hausleiter 2005 {published data only}
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Hoffmann 2007 {published data only}
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Hokimoto 2015 {published data only}
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Ishii 2012 {published data only}
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JACK‐EPC 2013 {published data only}
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Kim 2006 {published data only}
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Lansky 2000 {published data only}
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Lasave 2007 {published data only}
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MASTER 2012 {published data only}
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Meredith 2007 {published data only}
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Oyabu 2006 {published data only}
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PATENCY 2007 {published data only}
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PISCES 2005 {published data only}
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