Abstract
Percutaneous transluminal coronary intervention (PCI) is the most used myocardial revascularization technique for patients with coronary artery disease. Primary PCI with stent implantation is widely considered the gold standard for the treatment of ST-elevation myocardial infarction patients. Coronary stents, compared with balloon angioplasty, have reduced focal lesion restenosis. To reduce in-stent restenosis, drug-eluting stents (DES) were designed to locally release drugs inhibiting neointimal growth. Recent concerns have emerged on the potential higher risk of stent thrombosis with DES that might be even more pronounced among myocardial infarction patients. For these reasons, DES for primary PCI remains an “off-label” use. In the last several years, a number of randomized trials and registries have tested the safety and efficacy of DES in primary PCI. Data from these studies were analyzed in several meta-analyses, reasonably consistently demonstrating that the use of DES significantly decreased the need for revascularization without an increase in the incidence of death, recurrent infarction, or stent thrombosis at long-term follow-up.
Similar content being viewed by others
Abbreviations
- COMPARE:
-
Second-Generation Everolimus-Eluting and Paclitaxel-Eluting Stents in Real-Life Practice
- HORIZONS-AMI:
-
Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction
- PASEO:
-
Paclitaxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty
- PASSION:
-
Paclitaxel-Eluting Stent Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation
- RAVEL:
-
Randomized, Double-Blind Study with the Sirolimus Eluting BX Velocity Balloon Expandable Stent in the Treatment of Patients with De Novo Coronary Artery Lesions
- SESAMI:
-
Sirolimus Stent Versus Bare Stent in Acute Myocardial Infarction
- SIRIUS:
-
Sirolimus-Eluting Stent in De Novo Native Coronary Lesions
- STRATEGY:
-
Single High-Dose Bolus Tirofiban and Sirolimus Eluting Stent Versus Abciximab and Bare Metal Stent in Myocardial Infarction
- TYPHOON:
-
Trial to Assess the Use of the CYPHER® Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty
References
Papers of particular interest, published recently, have been highlighted as: • Of importance
Fishman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994;331(8):496–501.
Serruys P, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, et al. A comparison of balloon expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med. 1994;331(8):489–95.
Hoffman R, Mintz GS, Dusaillant GR, Popma JJ, Pichard AD, Satler LF, et al. Patterns and mechanism of in-stent restenosis. Circulation. 1996;94:1247–54.
Indolfi C, Esposito G, Di Lorenzo E, Rapacciuolo A, Feliciello A, Porcellini A, et al. Smooth muscle cell proliferation is proportional to the degree of balloon injury in a rat model of restenosis. Circulation. 1995;92:1230–5.
Indolfi C, Avvedimento EV, Di Lorenzo E, Esposito G, Rapacciuolo A, Giuliano P, et al. Activation of cAMP-PKA signalling in vivo inhibits smooth muscle cell proliferation induced by vascular injury. Nature Medicine. 1997;3:775–9.
Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80.
Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315–23.
Rao SV, Shaw RE, Brindis RG, Klein LW, Weintraub WS, Krone RJ, et al. Patterns and outcomes of drug-eluting coronary stent use in clinical practice. Am Heart J. 2006;152:321–6.
McFadden EP, Stabile E, Regar E, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004;364:1519–21.
Moreno R, Fernandez C, Hernandez R, et al. Drug-eluting stent thrombosis results from a pooled analysis including 10 randomized studies. J Am Coll Cardiol. 2005;45:954–9.
Mauri L, Hsieh W, Massaro JM, et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020–9.
U.S. Food and Drug Administration. Circulatory System Devices Panel meeting. December 7–8, 2006. Available at: http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#circulatory. Accessed February 7, 2007.
Virmani R, Guagliumi G, Farb A, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109:701–5.
Finn AV, Kolodgie FD, Harnek J, et al. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 2005;112:270–8.
Cook S, Wenaweser P, Togni M, Billinger M, Morger C, Seiler C, et al. Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation. 2007;115:2426–34.
Fujii K, Carlier SG, Mintz GS, Yang YM, Moussa I, Weisz G, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol. 2005;45:995–8.
Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, et al. Safety and efficacy of sirolimus and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356:998–1008.
Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007;356:989–97.
Win HK, Caldera AE, Maresh K, et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA. 2007;297:2001–9.
Marroquin OC, Selzer F, Mulukutla SR, et al. A comparison of bare-metal and drug-eluting stents for off-label indications. N Engl J Med. 2008;358:342–52.
Stone GW, Ellis SG, Cox DA, et al. A polymer-based paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221–31.
Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003;361:13–20.
De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A, et al. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol. 2008;126:37–44.
Keeley E, Hillis DL. Primary PCI for myocardial infarction with ST- segment elevation. N Engl J Med. 2007;356:47–54.
Antoniucci D, Migliorini A, Parodi G, Valenti R, Rodriguez A, Hempel A, et al. Abciximab-supported infarct artery stent implantation for acute myocardial infarction and long-term survival: a prospective, multicenter, randomized trial comparing infarct artery stenting plus abciximab with stenting alone. Circulation. 2004;109:1704–6.
Daemen J, Tanimoto S, Garcia-Garcia HM, et al. Comparison of three year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries). Am J Cardiol. 2007;99:1027–32.
Kernis SJ, Cohen D, Rein K. Clinical outcome associated with use of drug-eluting stents compared with bare metal stent for primary percutaneous intervention. Am J Cardiol. 2005;96(suppl 7A):47H. Abstract.
Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, et al. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation. 2006;113:2803–9.
Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007;28:2706–13.
• De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C, Valgimigli M, Di Lorenzo E, Dirksen MT, Spaulding C, Pittl U, Violini R, Percoco G, Marino P. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol. 2009;133:213–222. This is a complete meta-analysis of a randomized trial evaluating DES in acute MI.
Valgimigli M, Percoco G, Malagutti P, Campo G, Ferrari F, Barbieri D, et al. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA. 2005;293:2109–17.
Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006;355:1105–13.
Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrié D, et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006;355:1093–104.
Violini R, Musto C, De Felice F, Nazzaro MS, Cifarelli A, Petitti T, et al. Maintenance of long-term clinical benefit with sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction 3-year results of the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent In Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2010;55:810–4.
Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G, Wong SC, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009;360:1946–59.
Di Lorenzo E, De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, et al. PaclitAxel or sirolimus-eluting stent versus bare metal stent in primary angioplasty (PASEO) randomized trial. J Am Coll Cardiol Intv. 2009;2(6):515–23.
Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, et al. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: Four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009;158(4):e43–50.
Bolognese L, Carrabba N, Santoro GM, Valenti R, Buonamici P, Antoniucci D. Angiographic findings, time course of regional and global left ventricular function, and clinical outcome in diabetic patients with acute myocardial infarction treated with primary percutaneous transluminal coronary angioplasty. Am J Cardiol. 2003;91:544–9.
De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, et al. Impact of diabetes on long-term outcome in STEMI patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors and BMS or DES. J Thromb Thrombolysis. 2010;30(2):133–41.
Kedhi E, McFadden E, van Mieghem C, Sheikjoesoef K, Smits, Wassing J. COMPARE-AMI Everolimus-eluting and Paclitaxel-eluting Stents for treatment of ST-elevation Myocardial Infarction Two-year clinical outcome. http://www.tctmd.com/txshow.aspx?tid=2640&id=102230&trid=2.
• Kedhi E, Joesoef KS, McFadden E, et al. Second-generation everolimuseluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet 2010; 375: 201–209. This is a randomized trial in all-comers patients to evaluate the safety and efficacy of a second-generation DES.
• Wijns W, Kolh P, Danchin N, et al.: Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Association for Percutaneous Cardiovascular Interventions, Eur Heart J. 2010;31(20):2501–55. This is the most recent and comprehensive recommendations on strategies for myocardial reperfusion.
Disclosure
No potential conflicts of interest relevant to this article were reported.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Di Lorenzo, E., Carbone, G., Sauro, L. et al. Bare-Metal Stents Versus Drug-Eluting Stents for Primary Angioplasty: Long-Term Outcome. Curr Cardiol Rep 13, 459–464 (2011). https://doi.org/10.1007/s11886-011-0207-0
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11886-011-0207-0