What Would Be the Ideal Drug-eluting Stent for Managing Patients with Long Lesions?

Rhidian J Shelton , Daniel J Blackman
Interventional Cardiology Review, 2009;4(1):44-47
pdf icon download pdf ejournal view ejournal printer order reprints

Abstract

Drug-eluting stents (DES) substantially reduce the risk of restenosis, particularly in complex coronary disease. Their use is now standard in demanding anatomy, including in long lesions, which represent an increasing proportion of percutaneous coronary intervention (PCI) cases. However, long lesions pose a number of procedural and clinical challenges for DES, specifically stent deliverability, stent overlap and an increased risk of restenosis, peri-procedural myocardial infarction, geographical miss and stent thrombosis. The ideal DES for long lesions would incorporate a number of specific design characteristics to meet these challenges, including low late loss to minimise restenosis risk, thin struts to enhance deliverability and minimise risk of peri-procedural infarction and the availability of long lengths to minimise overlap and avoid geographical miss. It is clear from a knowledge of their properties, and from available data on DES performance in long lesions, that some currently available DES have superior design characteristics and clinical outcomes in the setting of diffuse disease. An awareness of these issues is essential for the practising interventional cardiologist in treating long lesions in routine clinical practice.
Keywords
Percutaneous coronary intervention, angioplasty, drug-eluting stents, long lesions, restenosis, stent deliverability
Disclosure Rhidian J Shelton has no conflicts of interest to declare. Daniel J Blackman has received speakers honoraria from Boston Scientific, is a member of the advisory boards of Abbott Vascular, Boston Scientific, Cordis (Johnson & Johnson) and Medtronic and has received travel and conference support from Boston Scientific, Cordis (Johnson & Johnson) and Medtronic.
Received: July 24, 2009 | Accepted September 07, 2009 | Citation Interventional Cardiology Review, 2009;4(1):44-47
Correspondence: Daniel J Blackman, Department of Cardiology, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK. E: daniel.blackman@leedsth.nhs.uk

The introduction of coronary stents in the late 1980s improved outcome over balloon angioplasty via a reduction in acute vessel closure, prevention of vessel recoil, increase in acute gain and a lower rate of clinical restenosis.1,2 However, in-stent restenosis (ISR), caused by smooth-muscle cell proliferation and migration, leading to neointimal hyperplasia, remains the Achilles’ heel of bare-metal stents (BMS). The development of drug-eluting stents (DES), which release antiproliferative drugs into the vessel wall to inhibit neointimal hyperplasia, has revolutionised percutaneous coronary intervention (PCI), dramatically reducing the incidence of ISR and target lesion revascularisation (TLR)3 and permitting the treatment of more complex and extensive coronary artery disease, including diffuse or long lesions.

Long lesions account for approximately 20% of contemporary PCI cases, and present specific challenges for drug-eluting stenting. In this article we describe the difficulties encountered in the treatment of long lesions using DES. We discuss how the characteristics and design of DES could be adapted to overcome these challenges and to deliver an optimal outcome. Finally, we relate these observations to contemporary DES, and discuss the evidence for the performance of the different commercially available DES in the setting of long lesions. For the purposes of this article we will focus on those DES with pivotal phase III randomised controlled trial data at the time of writing, namely the CYPHER sirolimus-eluting stent (SES) (Cordis, Johnson & Johnson, Miami Lakes, FL, US), the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific, Natick, MA, US), the Endeavor Sprint zotarolimus-eluting stent (ZES) (Medtronic, Santa Rosa, CA, US), the Xience V (Abbott Vascular, IL, US)/Promus (Boston Scientific) everolimus-eluting stent (EES) and the Biomatrix biolimus-eluting stent (BES) (Biosensors Interventional, Singapore), although emerging technologies will also be discussed.

References:
  1. Sigwart U, Puel J, Mirkovitch V, et al., Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty, N Engl J Med, 1987;316(12):701–6.
  2. 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(8):489–95.
  3. Kirtane AJ, Gupta A, Iyengar S, et al., Safety and Efficacy of Drug-Eluting and Bare Metal Stents, Circulation, 2009.
  4. Kastrati A, Elezi S, Dirschinger J, et al., Influence of lesion length on restenosis after coronary stent placement, Am J Cardiol, 1999;83(12):1617–22.
  5. Kereiakes D, Linnemeier TJ, Baim DS, et al., Usefulness of stent length in predicting in-stent restenosis (the MULTILINK stent trials), Am J Cardiol, 2000;86(3):336–41.
  6. Mercado N, Boersma E, Wijns W, et al., Clinical and quantitative coronary angiographic predictors of coronary restenosis: a comparative analysis from the balloon-tostent era, J Am Coll Cardiol, 2001;38(3):645–52.
  7. Tcheng JE, Lim IH, Srinivasan S, et al., Stent Parameters Predict Major Adverse Clinical Events and the Response to Platelet Glycoprotein IIb/IIIa Blockade: Findings of the ESPRIT Trial, Circ Cardiovasc Intervent, 2009;2(1):43–51.
  8. Kaltoft A, Jensen LO, Maeng M, et al., 2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry), J Am Coll Cardiol, 2009;53(8):658–64.
  9. James SK, Stenestrand U, Lindback J, et al., Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden, N Engl J Med, 2009;360(19):1933–45.
  10. Degertekin M, Arampatzis CA, Lemos PA, et al., Very long sirolimus-eluting stent implantation for de novo coronary lesions, Am J Cardiol, 2004;93(7):826–9.
  11. Serruys PW, Kutryk MJ, Ong AT, Coronary-artery stents, N Engl J Med, 2006;354(5):483–95.
  12. Eisenberg MJ, Konnyu KJ, Review of randomized clinical trials of drug-eluting stents for the prevention of in-stent restenosis, Am J Cardiol, 2006;98(3):375–82.
  13. Roukoz H, Bavry AA, Sarkees ML, et al., Comprehensive meta-analysis on drug-eluting stents versus bare-metal stents during extended follow-up, Am J Med, 2009;122(6): 581 e581–510.
  14. National Institute for Health and Clinical Excellence, UK, Drug-eluting stents for the treatment of coronary artery disease, 2008.
  15. Ramcharitar S, Hochadel M, Gaster AL, et al., An insight into the current use of drug eluting stents in acute and elective percutaneous coronary interventions in Europe: A report on the EuroPCI survey, EuroIntervention, 2007;3: 429–41.
  16. King SB, III, Smith SC, Jr, Hirshfeld JW, Jr, et al., 2007 Focused Update of the 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: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee, Circulation, 2008;117(2):261–95.
  17. 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(4):342–52.
  18. Mauri L, O’Malley AJ, Popma JJ, et al., Comparison of Thrombosis and Restenosis Risk from Stent Length of Sirolimus-Eluting Stents Versus Bare Metal Stents, Am J Cardiol, 2005;95(10):1140–45.
  19. Pocock SJ, Lansky AJ, Mehran R, et al., Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials, J Am Coll Cardiol, 2008;51(1):23–32.
  20. Mauri L, Orav EJ, Candia SC, et al., Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials, Circulation, 2005;112(18):2833–9.
  21. 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(12): 2440–47.
  22. 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(3):221–31.
  23. 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(14): 1315–23.
  24. Stone GW, Midei M, Newman W, et al., Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial, JAMA, 2008;299(16):1903–13.
  25. Windecker S, Serruys PW, Wandel S, et al., Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial, Lancet, 2008;372(9644):1163–73.
  26. Kim YH, Park SW, Lee CW, et al., Comparison of sirolimuseluting stent, paclitaxel-eluting stent, and bare metal stent in the treatment of long coronary lesions, Catheter Cardiovasc Interv, 2006;67(2):181–7.
  27. Diaz J, Sanchez A, Moreu J, et al., Everolimus-eluting stent in long lesions. The everlong multicenter registry (abstract), EuroIntervention, 2009;5(Suppl. E):67.
  28. Jain AK, Meredith IT, Lotan C, et al., Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry, Am J Cardiol, 2007;100(8B): 77M–83M.
  29. Kereiakes DJ, Wang H, Popma JJ, et al., Periprocedural and late consequences of overlapping Cypher sirolimuseluting stents: pooled analysis of five clinical trials, J Am Coll Cardiol, 2006;48(1):21–31.
  30. Jiro A, Gary SM, Neil JW, et al., Chronic Arterial Responses to Overlapping Paclitaxel-Eluting Stents: Insights From Serial Intravascular Ultrasound Analyses in the TAXUS-V and -VI Trials, JACC Cardiovasc Interv,.2008;1(2):161–7.
  31. Prasad A, Singh M, Lerman A, et al., Isolated elevation in troponin T after percutaneous coronary intervention is associated with higher long-term mortality, J Am Coll Cardiol, 2006;48(9):1765–70.
  32. Kini AS, Lee P, Marmur JD, et al., Correlation of postpercutaneous coronary intervention creatine kinase- MB and troponin I elevation in predicting mid-term mortality, Am J Cardiol, 2004;93(1):18–23.
  33. Stankovic G, Chieffo A, Iakovou I, et al., Creatine kinasemyocardial band isoenzyme elevation after percutaneous coronary interventions using sirolimus-eluting stents, Am J Cardiol, 2004;93(11):1397–1401, A1399.
  34. Selvanayagam JB, Porto I, Channon K, et al., Troponin elevation after percutaneous coronary intervention directly represents the extent of irreversible myocardial injury: insights from cardiovascular magnetic resonance imaging, Circulation, 2005;111(8):1027–32.
  35. Chu WW, Kuchulakanti PK, Torguson R, et al., Comparison of Clinical Outcomes of Overlapping Sirolimus- Versus Paclitaxel-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention, Am J Cardiol, 2006;98(12):1563–6.
  36. Stone GW, Ellis SG, Cannon L, 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, JAMA, 2005;294(10):1215–23.
  37. Popma JJ, Mauri L, O’Shaughnessy C, et al., Frequency and Clinical Consequences Associated With Sidebranch Occlusion During Stent Implantation Using Zotarolimus- Eluting and Paclitaxel-Eluting Coronary Stents, Circ Cardiovasc Intervent, 2009;2(2):133–9.
  38. Stone GW, Midei M, Newman W, et al., Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents: Two-Year Clinical Follow-Up From the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) III Trial, Circulation, 2009;119(5):680–86.
  39. Stella PR, Mueller R, Pavlakis G, et al., One year results of a new in situ length-adjustable stent platform with a biodegradable biolimus A9 eluting polymer: results of the CUSTOM-II trial, EuroIntervention, 2008;4(2):200–207.
  40. Schmidt W, Lanzer P, Behrens P, et al., A comparison of the mechanical performance characteristics of seven drugeluting stent systems, Catheter Cardiovasc Interv, 2009;73(3): 350–60.
  41. Leon MB, One-Year Clinical and Angiographic Results in Diabetics from ENDEAVOR IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System Versus Taxus in de novo Native Coronary Lesions (abstract), Trans Catheter Therapeutics, 2007.
  42. Costa MA, Angiolillo DJ, Tannenbaum M, et al., Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial), Am J Cardiol, 2008;101(12):1704–11.
  43. de la Torre-Hernández JM, Alfonso F, et al., Drug-Eluting Stent Thrombosis: Results From the Multicenter Spanish Registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos), J Am Coll Cardiol, 2008;51(10): 986–90.
  44. Meucci F, Falchetti E, Vittori, et al., Increased risk of subacute thrombosis after overlapping with drug-eluting stents: an analysis from the real-world eluting stent comparative Italian retrospective evaluation (RECIPE) study (abstr), J Am Coll Cardiol, 2005;45(Suppl. A):34A.
  45. Mauri L, Hsieh WH, Massaro JM, et al., Stent thrombosis in randomized clinical trials of drug-eluting stents, N Engl J Med, 2007;356(10):1020–29.

Suggest a topic for future coverage