Ground-breaking Innovation Proves Superior - The Weight of Evidence Behind The Cypher Sirolimus-eluting Coronary Stent

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Abstract

The introduction of the Cypher® Sirolimus-eluting
coronary stent in 2002 revolutionised the treatment of
patients with coronary artery stenosis and initiated the
drug-eluting stent (DES) era.

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The introduction of the Cypher├é┬« Sirolimus-eluting coronary stent in 2002 revolutionised the treatment of patients with coronary artery stenosis and initiated the drug-eluting stent (DES) era. Uncoated or bare metal stents (BMS), although a significant improvement on previously available therapies, are associated with significant restenosis due to neointimal hyperplasia following stent placement. The Cypher stent elutes the unique antiproliferative agent sirolimus, a potent and selective inhibitor of neointimal proliferation. Pivotal clinical trials showed that, compared with BMS, the Cypher stent significantly reduced neointimal hyperplasia (measured angiographically as late loss) and in-stent restenosis.1–4 Clinical outcomes were also significantly improved, with lower rates of major adverse cardiac event (MACE) and target lesion revascularisation (TLR).1–4 These clinical benefits have been sustained up to four years post-procedure.5–9 The following year (2003) saw the launch of Cypher Select™, the first next-generation DES, designed to provide enhanced deliverability, flexibility and conformability.

Head-to-head Superiority
The success of the Cypher stent decisively proved the DES concept, and competing DES soon appeared. The paclitaxel-eluting Taxus├é┬« stent received approval from the US Food and Drug Administration (FDA) in 2004. Unsurprisingly, the pivotal studies for Taxus showed improved outcomes versus BMS. However, these trials also demonstrated a consistently higher late loss compared with data gathered in similar Cypher studies.1,2,10–14

The results of Cypher–Taxus head-to-head studies have confirmed that the Cypher stent is significantly superior to Taxus with respect to inhibition of late loss.15–21 The superior results for in-stent late loss are strikingly consistent across a range of lesion complexities and patient types, including non-complex de novo lesions,15 long lesions,16 patients with acute myocardial infarction (AMI),17 small vessels,18 patients with diabetes19 and patients with in-stent restenosis.20
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References
  1. Morice M C et al., ├óÔé¼┼øA randomized comparison of a sirolimus-eluting stent with a standard stent for coronaryrevascularization├óÔé¼┼Ñ, N Engl J Med (2002);346: pp. 1,773├óÔé¼ÔÇ£1,780.
  2. Moses J W et al., ├óÔé¼┼øSirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery├óÔé¼┼Ñ,N Engl J Med (2003);349: pp. 1,315├óÔé¼ÔÇ£1,323.
  3. Schofer J et al., ├óÔé¼┼øSirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries:double-blind, randomised controlled trial (E-SIRIUS)├óÔé¼┼Ñ, Lancet (2003);362: pp. 1,093├óÔé¼ÔÇ£1,099.
  4. Schampaert E et al., ├óÔé¼┼øThe Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novolesions in small native coronary arteries (C-SIRIUS)├óÔé¼┼Ñ, J Am Coll Cardiol (2004);43: pp. 1,110├óÔé¼ÔÇ£1,115.
  5. Fajadet J et al., ├óÔé¼┼øMaintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of theRAVEL trial├óÔé¼┼Ñ, Circulation (2005);111: pp. 1,040├óÔé¼ÔÇ£1,044.
  6. Weisz G et al., ├óÔé¼┼øTwo-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent inde Novo Native Coronary Lesions (SIRIUS) trial├óÔé¼┼Ñ, J Am Coll Cardiol (2006);47: pp. 1,350├óÔé¼ÔÇ£1,355.
  7. Sousa J E et al., ├óÔé¼┼øA randomised, double-blind study with the sirolimus-eluting Bx Velocity balloon expandable stent in thetreatment of patients with de novo native coronary artery lesions: RAVEL 4-Year Follow-up├óÔé¼┼Ñ, presented at EuroPCR2005.
  8. Sousa J E et al., ├óÔé¼┼øFour-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-elutingstents├óÔé¼┼Ñ, Circulation (2005);111: pp. 2,326├óÔé¼ÔÇ£2,329.
  9. Leon M B et al., ├óÔé¼┼øLong-Term Clinical Benefit of Cypher Sirolimus-eluting Coronary Stents: Three-Year Follow-Up ofthe Sirius Study├óÔé¼┼Ñ, presented at ACC 2005.
  10. Schofer J, ├óÔé¼┼øNEW SIRIUS├óÔé¼┼Ñ, presented at ACC 2004.
  11. Moses J, ├óÔé¼┼øDIRECT├óÔé¼┼Ñ, presented at ACC 2004.
  12. Colombo A et al., ├óÔé¼┼øRandomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxelelutingstents for coronary artery lesions├óÔé¼┼Ñ, Circulation (2003);108: pp. 788├óÔé¼ÔÇ£794.
  13. Stone G W et al., ├óÔé¼┼øA polymer-based, paclitaxel-eluting stent in patients with coronary artery disease├óÔé¼┼Ñ, N Engl J Med(2004);350: pp. 221├óÔé¼ÔÇ£231.
  14. Dawkins K D et al., ├óÔé¼┼øClinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronaryartery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice├óÔé¼┼Ñ,Circulation (2005);112: pp. 3,306├óÔé¼ÔÇ£3,313.
  15. Morice M C et al., ├óÔé¼┼øSirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: arandomized controlled trial├óÔé¼┼Ñ, JAMA (2006);295: pp. 895├óÔé¼ÔÇ£904.
  16. Hong M K, ├óÔé¼┼øRandomized Comparison of the Efficacy of Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent in theTreatment of Long Native Coronary Lesions (LONG-DES II) Trial├óÔé¼┼Ñ, presented at ACC 2006.
  17. Lee J H et al., ├óÔé¼┼øRandomized trial of sirolimus- versus paclitaxel-eluting stents for the treatment of acute ST-Elevationmyocardial infarction├óÔé¼┼Ñ, presented at ACC 2006.
  18. Mehilli J et al., ├óÔé¼┼øRandomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels├óÔé¼┼Ñ, Eur Heart J(2006);27: pp. 260├óÔé¼ÔÇ£266.
  19. Dibra A et al., ├óÔé¼┼øPaclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients├óÔé¼┼Ñ, N Engl J Med(2005);353: pp. 663├óÔé¼ÔÇ£670.
  20. Kastrati A et al., ├óÔé¼┼øSirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences inpatients with coronary in-stent restenosis: a randomized controlled trial├óÔé¼┼Ñ, JAMA (2005);293: pp. 165├óÔé¼ÔÇ£171.
  21. Windecker S et al., ├óÔé¼┼øSirolimus-eluting and paclitaxel-eluting stents for coronary revascularization├óÔé¼┼Ñ, N Engl J Med(2005);353: pp. 653├óÔé¼ÔÇ£662.
  22. Mauri L et al., ├óÔé¼┼øRobustness of late lumen loss in discriminating drug-eluting stents across variable observational andrandomized trials├óÔé¼┼Ñ, Circulation (2005);112: pp. 2,833├óÔé¼ÔÇ£2,839.
  23. Moreno R et al., ├óÔé¼┼øLate Loss after Drug Eluting Stent Implantation. Does it Have Clinical Significance?├óÔé¼┼Ñ, presented atAHA 2005.
  24. Kandzari D E, ├óÔé¼┼øENDEAVOR-III. A Prospective Randomized Comparison of Zotarolimus-Eluting and SirolimusEluting Stents in Patients With Coronary Artery Disease├óÔé¼┼Ñ, presented at TCT 2005.
  25. Ardissino D et al., ├óÔé¼┼øSirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomizedtrial├óÔé¼┼Ñ, JAMA (2004);292: pp. 2,727├óÔé¼ÔÇ£2,734.
  26. Sabate M et al., ├óÔé¼┼øRandomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronaryrevascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial├óÔé¼┼Ñ, Circulation(2005);112: pp. 2,175├óÔé¼ÔÇ£2,183.
  27. Spratt J C et al., ├óÔé¼┼øPlaque stabilisation by systemic and local drug administration├óÔé¼┼Ñ, Heart (2004);90: pp. 1,392├óÔé¼ÔÇ£1,394.
  28. Spaulding C, ├óÔé¼┼øTrial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with BalloonAngioplasty (TYPHOON) Trial├óÔé¼┼Ñ, presented at ACC 2006.
  29. Holmes D R Jr. et al., ├óÔé¼┼øSirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents:the SISR randomized trial├óÔé¼┼Ñ, JAMA (2006);295: pp. 1,264├óÔé¼ÔÇ£1,273.
  30. Suttorp M J et al., ├óÔé¼┼øPrimary Stenting of Occluded Native Coronary Arteries the PRISON II Study.├óÔé¼┼Ñ, presented at TCT 2005.
  31. Pan M, ├óÔé¼┼øCORPAL-BIF├óÔé¼┼Ñ, presented at AHA 2005.
  32. Serruys P W et al., ├óÔé¼┼øFive-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├óÔé¼┼Ñ, J Am Coll Cardiol(2005);46: pp. 575-581.
  33. Serruys P W, ├óÔé¼┼øARTS II. Part II of the Arterial Revascularization Therapies Study of the Cypher Stent in the treatmentof patients with de novo coronary artery lesions.├óÔé¼┼Ñ, presented at ACC 2005.
  34. Goy J J et al., ├óÔé¼┼øA prospective randomized comparison between paclitaxel and sirolimus stents in the real world ofinterventional cardiology: the TAXi trial.├óÔé¼┼Ñ, J Am Coll Cardiol (2005);45(2): pp. 308├óÔé¼ÔÇ£311.
  35. Rogers C et al., Pushing drug-eluting stents into uncharted territory: simpler than you think--more complex than youimagine", Circulation (2006);113: pp. 2262├óÔé¼ÔÇ£2265.
  36. Kastrati A et al., "Predictive factors of restenosis after coronary implantation of sirolimus- or paclitaxel-eluting stents",Circulation (2006);113: pp. 2293├óÔé¼ÔÇ£2300.

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