Abstract
Drug-eluting stents (DESs) have revolutionized interventional cardiology over the past few years to the extent that balloon angioplasty and bare stents did in the 1980s and 1990s. The first DESs became commercially available in Europe in 2002 and in the US in 2003, and it is estimated that up to 80% of patients who undergo stent implantation in the US now receive a DES. Two devices, Cypher® sirolimus-eluting stents (Cordis Corporation, Miami Lakes, FL) and Taxus® paclitaxel-eluting stents (Boston Scientific Corporation, Natick, MN), are currently licensed for sale in both regions. Multiple new devices using different drugs, carriers and stents are currently undergoing clinical trials to establish their efficacy and obtain approval for commercialization. While the remarkable reduction of restenosis has accounted for the success of DESs, concerns remain regarding long-term follow-up; published 3-year follow-up results are available for fewer than 200 patients overall. Reports of late stent thrombosis have emerged, particularly in relation to discontinuation of antiplatelet therapy. In patients treated with DESs, long-term administration of at least one antiplatelet agent must be continued following completion of the mandatory dual antiplatelet regimen. In this review, we summarize the findings available for DESs so far, discuss emerging safety and efficacy data, and look at the future directions for these devices.
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References
Johnson & Johnson (online 14 February 2005) Stories of survival and hope mark the one million patient milestone for the CYPHER® sirolimus-eluting coronary stent (February 14, 2005). [http://www.jnj.com/news/jnj_news/20050214_094141.htm] (accessed 15 September 2005)
Boston Scientific (online 19 January 2005) Boston Scientific announces implantation of millionth TAXUS® Express coronary stent system [http://www.bostonscientific.com/common_templates/articleDisplayTemplate.jsp?task=tskPressRelease.jsp§ionId=2&relId=24,25&uniqueId=ABPR5502] (accessed September 15 2005)
van der Giessen WJ et al. (1996) Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 94: 1690–1697
Morice MC (2005) A Prospective, Randomized, Multi-Center Comparison Study of the CYPHER® Sirolimus-Eluting and TAXUS™ Paclitaxel-Eluting Stent Systems. American College of Cardiology 54th Annual Scientific Sessions: 2005 March 6–9; Orlando
Sousa JE et al. (2001) Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 103: 192–195
Rensing BJ et al. (2001) Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up. Eur Heart J 22: 2125–2130
Sousa JE et al. (2005) Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation 111: 2326–2329
Morice MC et al. (2002) A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346: 1773–1780
Moses JW et al. (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349: 1315–1323
Schofer J et al. (2003) Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 362: 1093–1099
Schampaert E et al. (2004) The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol 43: 1110–1115
Fajadet J et al. (2005) Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation 111: 1040–1044
Lemos PA et al. (2004) 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 109: 190–195
Ong AT et al.: Sirolimus-eluting stents remain superior to bare metal stents at 2 years in the real world—Long term results from the RESEARCH registry. J Am Coll Cardiol, in press
Grube E et al. (2003) TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 107: 38–42
Colombo A et al. (2003) Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 108: 788–794
Stone GW et al. (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350: 221–231
Stone GW (2005) Outcomes of the polymer-based, based, paclitaxel-eluting TAXUS stent in complex lesions. Principal clinical and angiographic results from the TAXUS-V pivotal randomized trial. Presented at the American College of Cardiology 54th Annual Scientific Sessions: 2005 March 6–9; Orlando
Grube E (2004) TAXUS VI A randomized trial of moderate rate release polymer-based paclitaxel-eluting TAXUS stent for the treatment of longer lesions. EuroPCR: 2004 May 25–28; Paris, France
Meredith IT et al. (2005) First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I Trial. EuroIntervention 1: 157–164
Wijns W (2005) ENDEAVOR II A randomized trial to evaluate the safety and efficacy of the medtronic AVE ABT-578 eluting driver coronary stent in de novo native coronary artery lesions. American College of Cardiology 54th Annual Scientific Sessions: 2005 March 6–9; Orlando
Grube E et al. (2004) Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation 109: 2168–2171
Serruys PW et al. (2005) A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention 1: 58–65
Grube E et al. (2005) Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9 eluting stent with a biodegradable polymer coating. EuroIntervention 1: 53–57
Serruys PW et al. (2005) The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: the Paclitaxel In-Stent Controlled Elution Study (PISCES). J Am Coll Cardiol 46: 253–260
Dawkins K (2005) EUROSTAR The European Cobalt Cobalt Stent with Antiproliferative for Restenosis Trial. EuroPCR: 2005 May 24–27; Paris, France
Gupta AK and Chow M (2003) Pimecrolimus: a review. J Eur Acad Dermatol Venereol 17: 493–503
Windecker S et al. (2005) Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med 353: 653–662
Ong AT et al. (2005) The unrestricted use of paclitaxel versus sirolimus-eluting stents for coronary artery disease in an unselected population—one year results of the Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry. J Am Coll Cardiol 45: 1135–1141
Kastrati A et al. (2005) Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 293: 165–171
Dibra A et al. (2005) Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med 353: 663–670
Virmani R and Farb A (1999) Pathology of in-stent restenosis. Curr Opin Lipidol 10: 499–506
Liuzzo JP et al. (2005) Sirolimus- and taxol-eluting stents differ towards intimal hyperplasia and re-endothelialization. J Invasive Cardiol 17: 497–502
Mohacsi PJ et al. (1997) Different inhibitory effects of immunosuppressive drugs on human and rat aortic smooth muscle and endothelial cell proliferation stimulated by platelet-derived growth factor or endothelial cell growth factor. J Heart Lung Transplant 16: 484–492
Hwang CW et al. (2005) Thrombosis modulates arterial drug distribution for drug-eluting stents. Circulation 111: 1619–1626
Schwartz RS et al. (2002) Drug-eluting stents in preclinical studies: recommended evaluation from a consensus group. Circulation 106: 1867–1873
Carter AJ et al. (2004) Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res 63: 617–624
Costa MA et al. (1999) Late coronary occlusion after intracoronary brachytherapy. Circulation 100: 789–792
Ong AT et al. (2005) Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion following bare metal, sirolimus or paclitaxel stent implantation. J Am Coll Cardiol 45: 947–953
Iakovou I et al. (2005) Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293: 2126–2130
Virmani R et al. (2004) Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation 109: 701–705
Ong AT et al. (2005) Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol 45: 2088–2092
Wang F et al. (2002) Late coronary stent thrombosis: early vs. late stent thrombosis in the stent era. Catheter Cardiovasc Interv 55: 142–147
Wenaweser P et al. (2005) Stent thrombosis following bare-metal stent implantation: success of emergency percutaneous coronary intervention and predictors of adverse outcome. Eur Heart J 26: 1180–1187
McFadden EP et al. (2004) Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 364: 1519–1521
Serruys PW et al. (2002) 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 106: 798–803
Degertekin M et al. (2003) Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation 108: 2747–2750
Tanabe K et al. (2005) Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: insights from the randomized TAXUS II trial. Circulation 111: 900–905
Grube E et al. (2004) High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial. J Am Coll Cardiol 44: 1368–1372
Serruys PW et al. (2004) Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial. J Am Coll Cardiol 44: 1363–1367
Gershlick A et al. (2004) Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial. Circulation 109: 487–493
Park SJ et al. (2003) A paclitaxel-eluting stent for the prevention of coronary restenosis. N Engl J Med 348: 1537–1545
Lansky AJ et al. (2004) Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions. Angiographic follow-up of the DELIVER clinical trial. Circulation 109: 1948–1954
van Hout BA et al. (2005) One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial. Heart 91: 507–512
Cohen DJ et al. (2004) Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial. Circulation 110: 508–514
Serruys PW and Ong ATL (2005) Cost effectiveness in the real world: Results from the RESEARCH and T-SEARCH registries. EuroPCR: 2005 May 24–27; Paris, France
Kaiser C et al. (2005) Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitats Trial (BASKET). Lancet 366: 921–929
Ong AT et al.: The SYNergy between Percutaneous Coronary Intervention with TAXus™ and Cardiac Surgery (SYNTAX) Study: Design, rationale and run-in phase. Am Heart J, in press
Serruys PW et al. (2005) Five year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: The final analysis of the Arterial Revascularization Therapies Study (ARTS) Randomized Trial. J Am Coll Cardiol 46: 575–581
Aoki J et al. (2005) Endothelial progenitor cell capture by stents coated with antibody against CD34. The HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) registry. J Am Coll Cardiol 45: 1574–1579
Windecker S et al. (2005) Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial. Circulation 111: 2617–2622
Walter DH et al. (2004) Local gene transfer of phVEGF-2 plasmid by gene-eluting stents: an alternative strategy for inhibition of restenosis. Circulation 110: 36–45
Holmes DR Jr et al. (2004) Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation 109: 634–640
Stone GW et al. (2004) One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation 109: 1942–1947
Grube E (2004) FUTURE clinical trials. Transcatheter Cardiovascular Therapeutics: 2004 Sept 27–Oct 1; Washington
Abizaid A et al. (2004) First human experience with the 17-β-estradiol-eluting stent: the Estrogen And Stents To Eliminate Restenosis (EASTER) trial. J Am Coll Cardiol 43: 1118–1121
Liu X et al. (2003) Study of antirestenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE): a first-in-human multicenter pilot trial. Catheter Cardiovasc Interv 60: 172–178
Goy JJ et al. (2005) A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: the TAXi trial. J Am Coll Cardiol 45: 308–311
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Ong, A., Serruys, P. Technology Insight: an overview of research in drug-eluting stents. Nat Rev Cardiol 2, 647–658 (2005). https://doi.org/10.1038/ncpcardio0378
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DOI: https://doi.org/10.1038/ncpcardio0378
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