CYPHER Stent - Confidence Inspired by Evidence

Login or register to view PDF.
ICR - Volume 3 Issue 1;2008:3(1):1-1

Coronary heart disease (CHD) is the single largest cause of mortality in Europe, accounting for 1.92 million deaths each year.1 CHD occurs when fatty deposits on the inner walls of a coronary artery cause a stenosis (narrowing) of the vessel, preventing adequate blood flow to the cardiac muscle. The stenosis can be treated by percutaneous transluminal coronary angioplasty (PTCA), a non-surgical procedure that deploys a balloon catheter to force open the stenosis and re-establish blood flow. In order to prevent 'recoilÔÇÖ of the artery walls, a wire mesh tube (stent) is placed at the lesion site.

The Drug-eluting Coronary Stent Revolution

The first stents - bare metal stents (BMS) - were subject to restenosis as a result of neointimal hyperplasia (proliferation of blood vessel cells) at the lesion site, leading to re-intervention in at least 20% of cases.2 The CYPHER® drug-eluting stent (DES) revolutionised the treatment of coronary artery stenosis by releasing (eluting) sirolimus, a potent and selective antiproliferative agent, at the lesion site after stent implantation. Early clinical studies showed that the CYPHER stent significantly reduced restenosis risk and improved short- and longer-term clinical outcomes compared with BMS.2,3

The Weight of Evidence for CYPHER

There is now a substantial body of evidence indicating that the CYPHER stent should be the DES of choice across a broad range of indications and patient types. CYPHER is superior to the paclitaxel-eluting Taxus® stent in terms of restenosis and re-intervention risk in complex lesions (de novo lesions,4,5 long lesions,6 small vessels7) and high-risk patients (acute myocardial infarction,8 diabetes,9 in-stent restenosis10). These data are now supporting CE Mark approvals in key indications, e.g. in acute myocardial infarction (AMI), where CYPHER has been shown to halve the one-year revascularisation rates compared with BMS.14

Additionally, a large-scale meta-analysis including more than 18,000 patients has enhanced the CYPHER stentÔÇÖs clinical superiority by confirming that the CYPHER stent significantly reduces re-intervention risk compared with Taxus.11 These differences in clinical performance may have important economic implications. It has been calculated that using a CYPHER stent instead of Taxus in high-risk patients could save nearly 2,000 per procedure.12

The weight of evidence for CYPHER versus more recent DES is even more emphatic. The zotarolimus-eluting Endeavor┬« stent has failed to demonstrate equivalence to CYPHER.13 No direct comparisons between the everolimus-eluting Xience™ V stent and CYPHER have been published. Furthermore, there are currently no published data to support the efficacy of Endeavor or Xience V in high-risk patients or complex lesions.

Confidence Inspired by Evidence

Selecting a DES with strong clinical support and proven outcomes is more important than ever before. The weight of evidence across multiple indications, combined with an unmatched safety database, makes the CYPHER stent the rational choice of DES. Ôûá

  1. Allender S, Scarborough P, Peto V, et al, European cardiovascular disease statistics. Brussels: European Heart Network; 2008.
  2. 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.
    Crossref | PubMed
  3. Sousa JE, Morice MC, Serruys PW, et al, A randomised, doubleblind study with the sirolimus-eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions: RAVEL 4-Year Follow-up. Presented at EuroPCR 2005.
  4. Morice MC, Colombo A, Meier B, et al, Sirolimus- vs paclitaxeleluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial, JAMA, 2006;295:895-904.
    Crossref | PubMed
  5. Windecker S, Remondino A, Eberli FR, et al, Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization, N Engl J Med. 2005;353:653-62.
    Crossref | PubMed
  6. Hong MK, Randomized Comparison of the Efficacy of Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent in the Treatment of Long Native Coronary Lesions (LONG-DES II) Trial. Presented at ACC 2006.
  7. 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.
    Crossref | PubMed
  8. Lee JH, Kim HS, Lee SW, et al, Randomized trial of sirolimusversus paclitaxel-eluting stents for the treatment of acute STElevation myocardial infarction. Presented at ACC 2006.
  9. Dibra A, Kastrati A, Mehilli J, et al, Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients, N Engl J Med, 2005;353:663-70.
  10. Kastrati A, Mehilli J, von Beckerath N, et al, 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, 2005;293:165-71.
    Crossref | PubMed
  11. 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(9591):937-48.
    Crossref | PubMed
  12. Elezi S, Dibra A, Folkerts U, et al, Cost Analysis From Two Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel- Eluting Stents in High-Risk Patients With Coronary Artery Disease, J Am Coll Cardiol, 2006;48:262-7.
    Crossref | PubMed
  13. Kandzari DE. ENDEAVOR-III. A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus- Eluting Stents in Patients With Coronary Artery Disease. Presented at TCT 2005.
  14. Press Release, 22nd July 2008. CYPHER┬« SELECT™ PLUS Sirolimus-eluting Coronary Stent Receives CE Mark Approval for Treatment of Heart Attacks. Cordis Corporation,Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in High- Risk Patients With Coronary Artery Disease, J Am Coll Cardiol, 2006;48:262-7.