CYPHER Stent - Confidence Inspired by Evidence

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Citation
ICR - Volume 3 Issue 1;2008:3(1):1-1
DOI
http://dx.doi.org/10.15420/icr.2008.3.1.1

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

References
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