Drug-eluting stents have radically changed the way we treat coronary artery disease. They offer lower restenotic rates compared with the bare metal stents and this enables more challenging and complex lesions to be treated. However, there are still limitations as restenosis has not been completely abolished and there are concerns about stent thrombosis. The next generation stents offer the technology to address these pertinent issues. This review examines the new analogs of the sirolimus family and their use in novel stent platforms, including the use of biodegradable and bioabsorbable materials employed in both stents and on the polymer. ‘Reservoir stents’ that are specially designed to contain layers of drugs in pockets with different release profiles are discussed and an insight into the emerging field of bioengineered stents is highlighted.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Price includes VAT for USA
The use of trade names is for product identification purposes only and does not imply endorsement.
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.
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: 1942–7.
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.
Ong AT, Hoye A, Aoki J, et al. Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation. J Am Coll Cardiol 2005; 45: 947–53.
Ong AT, McFadden EP, Regar E, et al. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol 2005; 45: 2088–92.
Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005; 293: 2126–30.
Hoye A, Iakovou I, Ge L, et al. Long-term outcomes after stenting of bifurcation lesions with the ‘crush’ technique: predictors of an adverse outcome. J Am Coll Cardiol 2006; 47: 1949–58.
Kuchulakanti PK, Chu WW, Torguson R, et al. Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation 2006; 113: 1108–13.
Smith Jr SC, Feldman TE, Hirshfeld Jr JW, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention). Circulation 2006; 113: el66–286.
Kim YH, Park SW, Hong MK, et al. Comparison of simple and complex stenting techniques in the treatment of unprotected left main coronary artery bifurcation stenosis. Am J Cardiol 2006; 97: 1597–601.
Mehilli J, Dibra A, Kastrati A, et al. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J 2006; 27: 260–6.
Hoye A, Tanabe K, Lemos PA, et al. Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. J Am Coll Cardiol 2004; 43: 1954–8.
Ge L, Iakovou I, Cosgrave J, et al. Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions. Eur Heart J 2005; 26: 1056–62.
Burke SE, Kuntz RE, Schwartz LB. Zotarolimus (ABT-578) eluting stents. Adv Drug Deliv Rev 2006; 58(3): 437–46.
Meredith IT, Ormiston J, Whitbourn R, et al. Endeavor I, ‘first in man’, safety and efficacy study, 12 months clinical, angiographin and intravescular ultrasound results [abstract no. 2623]. Circulation 2004; 110: III–563–4.
Fajadet J, Wijns W, Laarman GJ, et al. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation 2006; 114: 798–806.
Kandzari DE, Leon MB, Popma JJ, et al. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol 2006; 48: 2440–7.
Agostoni P, Valgimigli M, Abbate A, et al. Is late luminal loss an accurate predictor of the clinical effectiveness of drug-eluting stents in the coronary arteries? Am J Cardiol 2006; 97: 603–5.
Kandzari DE, Leon MB. Overview of pharmacology and clinical trials program with the zotarolimus-eluting endeavor stent. J Interv Cardiol 2006; 19: 405–13.
Chevalier B. The ZoMaxx clinical trial programme. Paris: EuroPCR, 2006.
Abizaid A, Lansky A, Fitzgerald P, et al. Percutaneous coronary revascularization using a trilayer phosphorylcholine-coated zotarolimus-eluting stent: the ZoMaxx IVUS trial [lecture]. 55th Annual Scientific Session of the American College of the Cardiology; 2006 Mar 11–14; Atlanta (GA): American College of Cardiology, 2006.
TCT daily: ZOMAXX I: mixed results with zotarolimus-eluting stent. J Interv Cardiol 2007; 20: 35.
Tsuchida K, Pick JJ, Neumann FJ, et al. One-year results of a durable polymerever-olimus-eluting stent in de novo coronary narrowings (the SPIRIT FIRST trial). Eurointervention 2005; 1: 266–72.
Serruys PW, Wiemer M, Carrie D, et al. The SPIRIT II trial. Eurointervention 2006; 2: 286–94.
Stone G. SPIRIT III nine-month pivotal clinical data results i2 [lecture]. Summit American College of Cardiology’s 56th Annual Scientific Session; 2007 Mar 24–27; New Orleans (LA): American College of Cardiology, 2007.
Grube E, Hauptmann K, Buellesfeld L, et al. Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9™ eluting stent with a biodegradablepolymer coating. Eurointervention 2005; 1: 53–7.
Chevalier B, Serruys PW, Siber S, et al. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus, paclitaxel-eluting coronary stent inpatients with stenosis in native arteries: the Nobori 1 trial. Eurolntervention 2007; 2: 426–34.
Costa RA, Lansky AJ, Mintz GS, et al. Angiographie results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial). Am J Cardiol 2005; 95: 113–6.
Tsuchiya Y, Lansky AJ, Costa RA, et al. Effect of everolimus-eluting stents in different vessel sizes (from the pooled FUTURE I and II trials). Am J Cardiol 2006; 98: 464–9.
Morice MC, Bestehorn HP, Carrie D, et al. Direct stenting of the de novo coronary stenoses with tacrolimus-eluting versus carbon-coated carbostents: the randomized JUPITER II trial. Eurointervention 2006; 2: 45–52.
FDA happenings/around the industry. J Interven Cardiol 2006; 19: 472–4.
Dawkins K. The Eurostar trial [lecture]. Paris Course on Revascularization; 2005 May 24–27; Paris: EuroPCR, 2005.
van der Giessen WJ, Lincoff AM, Schwartz RS, et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 1996; 94: 1690–7.
Di Mario C, Griffiths H, Goktekin O, et al. Drug-eluting bioabsorbable magnesium stent. J Interv Cardiol 2004; 17: 391–5.
Erbel R. Coronary results of the first absorable metal stent: the PROGRESS-I trial [abstract 2405–9]. 55th Annual Scientific Session of the American College of Cardiology; 2006 Mar 11–14; Atlanta (GA): American College of Cardiology, 2006.
Vogt F, Stein A, Rettemeier G, et al. Long-term assessment of a novel biodegradable paclitaxel-eluting coronary polylactide stent. Eur Heart J 2004; 25: 1330–40.
Tamai H, Igaki K, Kyo E, et al. Initial and 6-month results of biodegradable poly-1-lactic acid coronary stents in humans. Circulation 2000; 102: 399–404.
Ormiston JA, Webster MW, Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv 2007; 69: 128–31.
Grube E, Sonoda S, Ikeno F, et al. Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation 2004; 109: 2168–71.
Serruys P. Emerging technology 1: stents. New drugs [lecture]. 55th Annual Scientific Session of the American College of Cardiology; 2006 Mar 11–14; Atlanta (GA): American College of Cardiology, 2006.
Gambhir DS. The infinnium polymere-based paclitaxel drug-eluting stent: results from real world clinical trials SIMPLE 1 and SIMPLE 2 [lecture]. 16th Transcatheter Cardiovascular Therapeutics (TCT 2004) Annual Scientific Symposium; 2004 Sep 27–Oct 1; Washington, DC: Cardiovascular Research Foundation, 2004.
Vranckx P, Serruys PW, Gambhir S, et al Biodegradable-polymer-based, paclitaxel-eluting Infinnium™ stent: 9-month clinical and angiographic follow-up results from the SIMPLE II prospectivemulti-centre registry study. Eurointervention 2006; 2: 310–7.
Dani SI. A biodegradable polymer-based sirolimus-eluting stent for treatment of secondary complication in patients with coronary artery disease [abstract no. AS-64]. Angioplasty Summit 2006-TCT Asia; 2006 Apr 26–28; Seoul, Korea: Cardiovascular Research Foundation, 2006.
Lele S. Heparin sirolimus stent [lecture]. Paris: EuroPCR, 2006.
Virmani R. Atrium medical bioabsorbable oil based delivery of a sirolimus analogue from a stent and balloon [lecture]. 17th Transcatheter Cardiovascular Therapeutics (TCT 2005) Scientific Sessions; 2005 Oct 16–21; Washington, DC: Cardiovascular Research Foundation, 2005.
Wieneke H, Dirsch O, Sawitowski T, et al. Synergistic effects of a novel nanoporous stent coating and tacrolimus on intima proliferation in rabbits. Catheter Cardiovasc Interv 2003; 60: 399–407.
Kollum M, Farb A, Schreiber R, et al. Particle debris from a nanoporous stent coating obscures potential antiproliferative effects of tacrolimus-eluting stents in a porcine model of restenosis. Catheter Cardiovasc Interv 2005; 64: 85–90.
Gerckens U, Buellesfeld L, Horskotte D, et al. Evaluation of a tacrolimus-eluting coronary stent with nanoporous ceramic coating in treatment of native coronary artery lesions: phase I and II of the PRESENT study [abstract]. J Am Coll Cardiol 2003; 41 (Suppl. A): 7A.
Wessely R, Hausleiter J, Michaelis C, et al. Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating. Arterioscler Thromb Vasc Biol 2005; 25: 748–53.
Hausleiter J, Kastrati A, Wessely R, et al. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J 2005; 26: 1475–81.
Conor Medsystems. Clinical, clinical trials [online]. Available from URL: http:// www.conormed.com/clin/ [Accessed 2007 Apr 26].
Serruys PW, Sianos G, Abizaid A, et al. 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 2005; 46: 253–60.
Aoki J, Ong AT, Abizaid A, et al. One-year clinical outcome of various doses and pharmacokinetic release formulations of paclitaxel eluted from an erodable polymer: insight in the Paclitaxel In-Stent Controlled Elution Study (PISCES). Eurointervention 2005; 2: 165–72.
Kaul U. Erodablepolymer-reservoir paclitaxel drug eluting stents: II. Cobalt chromium platforms in complex lesions [lecture]. 16th Transcatheter Cardiovascular Therapeutics (TCT 2004) Annual Scientific Symposium; 2004 Sep 27–Oct 1; Washington, DC: Cardiovascular Research Foundation, 2004.
Serruys PW. The new CoStar™ stent: 12 month results with the new DES technology [lecture]. Paris Course on Revascularisation; 2005 May 24–27; Paris: EuroPCR, 2005.
Wijns W. CoStar™ Paclitaxel-eluting stent: relevance in drug-eluting stent clinical data landscape [lecture]. Paris Course on Revascularization; 2006 May 10–19; Paris: EuroPCR, 2006.
Serruys PW. Drug-eluting stents: results from clinical trials. The PISCES trials [lecture]. 55th Annual Scientific Session of the American College of Cardiology; 2006 Mar 11–14; Atlanta (GA): American College of Cardiology, 2006.
Aoki J, Serruys PW, van Beusekom H, et al. 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 2005; 45: 1574–9.
Serruys PW, On behalf of the HEALING II Investigators. The genous endothelial capture system. Final results from the HEALING II Study [abstract]. TCT2005, The Drug-Eluting Stent Summit; 2005 Oct 16–21; Washington, DC: The Cardiovascular Foundation, 2005.
Duckers H, Aoki J, de Heer H, et al. Circulating endothelial progenitor cells predict angiographic and intravascular ultrasound outcome following percutaneous coronary interventions: an interim analysis of the HEALING II trial using an endothelial progenitor cell capturing stent (Genous R Stent) [abstract no. TCT15]. Am J Cardiol 2005; 96 Suppl. 7A: 7H.
Windecker S, Mayer I, De Pasquale G, et al. Stent coating with titanium-nitride-oxide for reduction of neointimal hyperplasia. Circulation 2001; 104: 928–33.
Windecker S, Simon R, Lins M, et al. Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial. Circulation 2005; 111: 2617–22.
Dibra A, Kastrati A, Alfonso F, et al. Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J Am Coll Cardiol 2007; 49: 616–23.
Liu X, Huang Y, Hanet C, et al. Study of antirestenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE): a first-in-human multicenter pilot trial. Catheter Cardiovasc Interv 2003; 60: 172–8.
De Scheerder I. The Abbott vascular devices dexamethasone eluting stent: from STRIDE to the ‘real-world’ SAFE registry [lecture]. 15th Annual Transcatheter Cardiovascular Therapeutics (TCT 2003) Scientific Symposium; 2003 Sep 15–19; Washington, DC: Cardiovascular Research Foundation, 2003.
No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.
About this article
Cite this article
Ramcharitar, S., Vaina, S. & Serruys, P.W. The Next Generation of Drug-Eluting Stents. Am J Cardiovasc Drugs 7, 81–93 (2007). https://doi.org/10.2165/00129784-200707020-00001
- Stent Thrombosis
- Major Adverse Cardiac Event
- Target Lesion Revascularization