Clinical use of intracoronary bare metal stents
- Donald Cutlip, MD
Donald Cutlip, MD
- Section Editor — Interventional Cardiology
- Professor of Medicine
- Harvard Medical School
- Beth Israel Deaconess Medical Center
- J Dawn Abbott, MD, FACC
J Dawn Abbott, MD, FACC
- Associate Professor of Medicine
- Brown Medical School
The development of bare metal stents (BMS) was a major advance relative to balloon angioplasty in the management of symptomatic coronary artery disease. BMS prevented restenosis by attenuating early arterial recoil and contraction. However, the rate of clinically indicated target lesion repeat revascularization due to restenosis at one year remained relatively high at 10 to 20 percent of patients and is often due to excessive growth of neointima [1-3]. (See "Intracoronary stent restenosis", section on 'Incidence of restenosis'.)
Drug-eluting stents (DES) were developed to reduce the high rate of restenosis and subsequent need for repeat revascularization with BMS. Clinical trials have confirmed a reduction of as much as 50 to 70 percent in target lesion revascularization by DES compared with BMS. These findings have led to the preferential use of DES in most stent cases. However, as DES likely require a longer period of dual antiplatelet therapy to prevent stent thrombosis, they may not be appropriate for all patients. (See "Long-term antiplatelet therapy after coronary artery stenting in stable patients", section on 'Summary and recommendations'.)
This topic will attempt to clarify the role of BMS in contemporary coronary artery disease interventional practice. The discussions of the various types of DES and coronary artery stent types in development are found elsewhere. (See "Comparison of drug-eluting intracoronary stents" and "Bioresorbable polymer or scaffold drug-eluting coronary artery stents".)
All coronary artery stents consist of a metallic backbone (table 1). Drug-eluting stents (DES) have an antiproliferative drug, and a polymer that serves as the vehicle for the drug and also controls the drug release rate. The drug inhibits excessive growth of neointima, a major cause of restenosis. Since each DES is unique, differences may be observed with respect to deliverability (ease of placement), efficacy (prevention of restenosis), and safety (rates of stent thrombosis). (See "Comparison of drug-eluting intracoronary stents".)
BMS COMPARED WITH DES
We prefer drug-eluting stents (DES) to bare metal stents (BMS) in most clinical situations. Current-generation DES have lower rates of clinically indicated repeat revascularization compared with BMS and are not limited by late safety concerns as were the first-generation DES.
- Fischman DL, Leon MB, Baim DS, 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; 331:496.
- Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med 1994; 331:489.
- Cutlip DE, Chauhan MS, Baim DS, et al. Clinical restenosis after coronary stenting: perspectives from multicenter clinical trials. J Am Coll Cardiol 2002; 40:2082.
- Weisz G, Leon MB, Holmes DR Jr, et al. Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial. J Am Coll Cardiol 2009; 53:1488.
- Ellis SG, Stone GW, Cox DA, et al. Long-term safety and efficacy with paclitaxel-eluting stents: 5-year final results of the TAXUS IV clinical trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent). JACC Cardiovasc Interv 2009; 2:1248.
- Kimura T, Morimoto T, Nakagawa Y, et al. Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry. Circulation 2012; 125:584.
- Sarno G, Lagerqvist B, Fröbert O, et al. Lower risk of stent thrombosis and restenosis with unrestricted use of 'new-generation' drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 2012; 33:606.
- 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.
- Serruys PW, Degertekin M, Tanabe K, et al. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation 2002; 106:798.
- 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.
- Lemos PA, Serruys PW, van Domburg RT, et al. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the "real world": the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation 2004; 109:190.
- Morice MC, Serruys PW, Barragan P, et al. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol 2007; 50:1299.
- Kelbaek H, Kløvgaard L, Helqvist S, et al. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol 2008; 51:2011.
- Ong AT, van Domburg RT, Aoki J, et al. Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol 2006; 47:1356.
- Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003; 108:788.
- 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.
- Stone GW, Ellis SG, Cox DA, et al. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation 2004; 109:1942.
- Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007; 370:937.
- Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007; 356:998.
- Spaulding C, Daemen J, Boersma E, et al. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007; 356:989.
- Kastrati A, Mehilli J, Pache J, et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007; 356:1030.
- Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J 2006; 27:2784.
- Stone GW, Ellis SG, Colombo A, et al. Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation. Circulation 2007; 115:2842.
- Kirtane AJ, Gupta A, Iyengar S, et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation 2009; 119:3198.
- Hill RA, Boland A, Dickson R, et al. Drug-eluting stents: a systematic review and economic evaluation. Health Technol Assess 2007; 11:iii, xi.
- Tu JV, Bowen J, Chiu M, et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med 2007; 357:1393.
- Abbott JD, Voss MR, Nakamura M, et al. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol 2007; 50:2029.
- James SK, Stenestrand U, Lindbäck J, et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N Engl J Med 2009; 360:1933.
- Ko DT, Chiu M, Guo H, et al. Safety and effectiveness of drug-eluting and bare-metal stents for patients with off- and on-label indications. J Am Coll Cardiol 2009; 53:1773.
- Mauri L, Silbaugh TS, Wolf RE, et al. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts. Circulation 2008; 118:1817.
- Hannan EL, Racz M, Holmes DR, et al. Comparison of coronary artery stenting outcomes in the eras before and after the introduction of drug-eluting stents. Circulation 2008; 117:2071.
- Marzocchi A, Saia F, Piovaccari G, et al. Long-term safety and efficacy of drug-eluting stents: two-year results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) multicenter registry. Circulation 2007; 115:3181.
- Bønaa KH, Mannsverk J, Wiseth R, et al. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med 2016; 375:1242.
- Valgimigli M, Sabaté M, Kaiser C, et al. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis. BMJ 2014; 349:g6427.
- Palmerini T, Benedetto U, Biondi-Zoccai G, et al. Long-Term Safety of Drug-Eluting and Bare-Metal Stents: Evidence From a Comprehensive Network Meta-Analysis. J Am Coll Cardiol 2015; 65:2496.
- Valgimigli M, Patialiakas A, Thury A, et al. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol 2015; 65:805.
- Ariotti S, Adamo M, Costa F, et al. Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial. JACC Cardiovasc Interv 2016; 9:426.
- Urban P, Meredith IT, Abizaid A, et al. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med 2015; 373:2038.
- Authors/Task Force members, Windecker S, Kolh P, et al. 2014 ESC/EACTS 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)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014; 35:2541.