Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction.

AIMS To compare the efficacy and safety of drug-eluting stents vs. bare-metal stents in patients with acute ST-segment elevation myocardial infarction. METHODS AND RESULTS We performed a meta-analysis of eight randomized trials comparing drug-eluting stents (sirolimus-eluting or paclitaxel-eluting stents) with bare-metal stents in 2786 patients with acute ST-segment elevation myocardial infarction. All patients were followed up for a mean of 12.0-24.2 months. Individual data were available for seven trials with 2476 patients. The primary efficacy endpoint was the need for reintervention (target lesion revascularization). The primary safety endpoint was stent thrombosis. Other outcomes of interest were death and recurrent myocardial infarction. Drug-eluting stents significantly reduced the risk of reintervention, hazard ratio of 0.38 (95% CI, 0.29-0.50), P < 0.001. The overall risk of stent thrombosis: hazard ratio of 0.80 (95% CI, 0.46-1.39), P = 0.43; death: hazard ratio of 0.76 (95% CI, 0.53-1.10), P = 0.14; and recurrent myocardial infarction: hazard ratio of 0.72 (95% CI, 0.48-1.08, P = 0.11) was not significantly different for patients receiving drug-eluting stents vs. bare-metal stents. CONCLUSION The use of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction is safe and improves clinical outcomes by reducing the risk of reintervention compared with bare-metal stents.

[1]  Neville Kukreja,et al.  Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study , 2007, The Lancet.

[2]  Arianna Azzellino,et al.  Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). , 2007, Journal of the American College of Cardiology.

[3]  L. Clark,et al.  Primary stent implantation compared with primary balloon angioplasty for acute myocardial infarction: a meta-analysis of randomized clinical trials. , 2001, The American journal of cardiology.

[4]  J. J. Griffin,et al.  Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. , 2002, The New England journal of medicine.

[5]  Gregg W Stone,et al.  Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. , 2005, JAMA.

[6]  Marco Valgimigli,et al.  Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. , 2007, The New England journal of medicine.

[7]  Douglas G Altman,et al.  Systematic reviews in health care: Assessing the quality of controlled clinical trials. , 2001, BMJ.

[8]  Seung‐Jung Park,et al.  Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. , 2006, The American journal of cardiology.

[9]  D G Altman,et al.  Concealing treatment allocation in randomised trials , 2001, BMJ : British Medical Journal.

[10]  Mark C Simmonds,et al.  Meta-analysis of individual patient data from randomized trials: a review of methods used in practice , 2005, Clinical trials.

[11]  J. Tijssen,et al.  Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. , 2006, The New England journal of medicine.

[12]  Michael Joner,et al.  Drug-Eluting Stent and Coronary Thrombosis: Biological Mechanisms and Clinical Implications , 2007, Circulation.

[13]  S. Cobbe.  Thrombolysis in myocardial infarction , 1994, BMJ.

[14]  G. Campo,et al.  Safety and Long-Term Efficacy of Sirolimus Eluting Stent in ST-elevation Acute Myocardial Infarction: The REAL (Registro REgionale AngiopLastiche Emilia-Romagna) Registry , 2006, Cardiovascular Drugs and Therapy.

[15]  J. Sterne,et al.  Meta‒Analysis in Stata™ , 2008 .

[16]  Douglas G. Altman,et al.  Systematic Reviews in Health Care , 2001 .

[17]  T. Miyazaki,et al.  Comparison of activation process of platelets and neutrophils after coronary stent implantation versus balloon angioplasty for stable angina pectoris. , 2000, The American journal of cardiology.

[18]  Barbara T. Unger,et al.  Comparison of safety and efficacy of sirolimus-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction. , 2006, The American journal of cardiology.

[19]  Jeroen J. Bax,et al.  Preoperative comparison of different noninvasive strategies for predicting improvement in left ventricular function after coronary artery bypass grafting. , 2003, The American journal of cardiology.

[20]  A. Kastrati,et al.  Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. , 2007, Journal of the American College of Cardiology.

[21]  E. Bramucci,et al.  Sirolimus-eluting versus uncoated stents in acute myocardial infarction. , 2006, The New England journal of medicine.

[22]  Gd Rotterdam.  Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients , 2006 .

[23]  George Davey Smith,et al.  Where now for meta-analysis? , 2002, International journal of epidemiology.

[24]  P. Serruys,et al.  A comparison of systematic stenting and conventional balloon angioplasty during primary percutaneous transluminal coronary angioplasty for acute myocardial infarction. STENTIM-2 Investigators. , 2000, Journal of the American College of Cardiology.

[25]  J. Boura,et al.  Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction : a quantitative review of 23 randomised trials , 2022 .

[26]  P. Serruys,et al.  Short- and long-term clinical benefit of sirolimus-eluting stents compared to conventional bare stents for patients with acute myocardial infarction. , 2004, Journal of the American College of Cardiology.

[27]  V. Pasceri,et al.  Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. , 2007, American heart journal.

[28]  T. Harr,et al.  Primary stenting versus primary balloon angioplasty for treating acute myocardial infarction. , 2005, The Cochrane database of systematic reviews.

[29]  Douglas G. Altman,et al.  Systematic Reviews in Health Care: Meta-Analysis in Context: Second Edition , 2008 .

[30]  P. Armstrong,et al.  Transition from meeting abstract to full-length journal article for randomized controlled trials. , 2006, JAMA.

[31]  N. Laird,et al.  Meta-analysis in clinical trials. , 1986, Controlled clinical trials.

[32]  E. Braunwald,et al.  Platelet activation in patients after an acute coronary syndrome: results from the TIMI-12 trial. Thrombolysis in Myocardial Infarction. , 1999, Journal of the American College of Cardiology.

[33]  D. Altman,et al.  Measuring inconsistency in meta-analyses , 2003, BMJ : British Medical Journal.

[34]  J. Ottervanger,et al.  Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients , 2005, Heart.

[35]  R. Ferrari,et al.  Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. , 2005, JAMA.