CYPHER stent

Two-vessel coronary artery disease (60% right coronary artery [RCA] and 80% left anterior descending artery [LAD] occlusion) after intracoronary CYPHER stent placement to the mid-LAD artery lesion 10 months ago. 

While drug eluting stents effectively tackled the problem of stent restenosis, other issues have emerged in recent times. In 2003, the FDA issued a warning regarding cases of sub-acute thrombosis (SAT) with the CYPHER stent that resulted in some deaths. This... 

The CYPHER stent employs two nonerodible polymers polyethylene-co-vinyl acetate (PEVA) and poly-n-butyl methacrylate (PBMA), The combination of sirolimus and these two polymers constitutes the basecoat formulation that is applied to a stent treated with paryleneC. In addition, a drug-free topcoat of PBMA polymer is applied to control the release kinetics of sirolimus (59), making this a diffusion-controlled reservoir device. The chemical structure of the polymers used in the CYPHER stent is shown in Figure 4,... 

BMS in over 1000 patients (61), These and other studies provided evidence for the clinical utility of the CYPHER stent for the prevention of ISR and are discussed in Chapter 10. 

In long-term follow-up of the RAVEL trial (73), clinical benefit with sirolimus-eluting coronary stents has been maintained. Using cumulative one to three-year event-free survival rates, treatment with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of target lesion revascularization up to three years after device implantation. As recently shown by both Kastrati and coworkers (74) and Windecker et al. (75), the Cypher stent eluting sirolimus is highly effective and may have clinical benefit beyond alternative DES products. 

The stent struts are comprised of the metal and the polymer, and, overtime, the drug disappears (e.g., with the Cypher stent) or some drug will remain (e.g., with the Taxus stent). Thus, there is the potential for some metal, polymer, and drug to remain exposed to the blood stream. Using high-resolution imaging techniques, intimal hyperplasia is seen when looking at BMS in vivo. 

Initial anecdotal reports of subacute stent thrombosis first surfaced after introduction of the Cypher stent in 2003 when 360 cases (out of a total 575,000 stents implanted) were reported. However, a significant risk... 

Y. Otsuka, et al.. Scanning electron microscopic analysis of defects in polymer coatings of three commercially available stents comparison of BiodivYsio, Taxus and Cypher stents, J. Invasive Cardiol. 19 (2)... 

First-in-man clinical trials with the Cypher stent system were performed at the Institute Dante Pazzanese de Cardiologia in the year 2000, comparing a moderate-release cypher stent with a slow-release one in 15 human patients. At the time stent-technology had been an emerging field and this clinical trial helped establish the therapeutic benefits of DBS use by demonstrating slowed neointimal growth in stented patients [1]. 

FIGURE 4.5 A 72-year-old man with medical history remarkable for hypertension and dyslipidemia presented with posterior circulation infarct (a). CTA and posterior circulation angiography (left vertebral artery injection) performed demonstrated severe mid-basilar artery stenosis (b and c). Left vertebral artery injection demonstrated near-complete reversal of the stenosis after a drug-eluting balloon expandable stent (Cypher, Cordis Johnson Johnson) was deployed (d). 

Polymers used in the CYPHER sirolimus-eluting stent... 

The pivotal Sirolimus-coated BX VELOCITY Balloon-Expandable Stent in Treatment of Patients with De Novo Coronary Artery Lesions (SIRIUS) study of the CYPHER SES demonstrated a low rate of reintervention compared with... 

Polymers used in the CYPHER sirolimus-eluting stent. Abbreviations PBMA, poly-n-butyl methacrylate PEVA, polyethylene-co-vinyl acetate. 

Cypher Instructions for Use. Cypher sirolimus-eluting coronary stent on Raptor over-the-wire delivery system, http // www.fda.gov/cdrh/PDF2/p020026c.pdf Accessed Aug 8, 2006. 

Cordis Corporation. A Multi-Center, Non-Randomised Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion (TROPICAL Study), 2006. 

DES in the United States at this time. They are the Cypher sirolimus-eluting stent manufactured by Cordis, a division of Johnson Johnson and the Taxus paclitaxel-eluting stent manufactured by Boston Scientific. 

The Cypher sirolimus-eluting stent from Cordis uses a blend of poly(ethylene-co-vinyl acetate) (PEVA) and poly(n-butyl methacrylate) (PBMA) as the polymeric matrix for sirolimus release. Both PEVA and PBMA have individually been used as implants in humans and demonstrated excellent biocompatibility. The blend of PEVA and PBMA is physically mixed with sirolimus in a weight ratio of 2 1. In vivo studies have shown that the majority of the drug is released in a sustained fashion in 30 days with complete drug release in 90 days as... 

In vivo sirolimus release profile from the Cypher sirolimus eluting stent. 

With the recent development of angioplasty combined with DES such as the Cypher-Coronary Stent marketed by Cordis/J J Pharmaceuticals, treatment of the culprit vessel in myocardial infarction has had a significant and meaningful advance (69,70). By engineering the device to elute sirolimus... 

Drug-eluting stents have been very effective. However, clinical concerns remain, despite the low thrombosis rates of I % to 2%. Residual thrombosis can lead to a large myocardial infarction or frequently death. The thrombosis rates are quite similar with the Cypher, Taxus, and bare metal stents (BMSs). However the question is whether the thrombosis can be reduced close to zero, without the patient taking antiplatelet drugs. 

Morice M-C, Serruys PVY, Colombo A, et al. Eight-month outcome of the REALITY Study a prospective, randomized, multi-center head-to-head comparison of the sirolimus-eluting stent (Cypher) and the paclitaxel-eluting stent (Taxus). Presented at the 2005 Annual Scientific Session ofthe American College of Cardiology, Orlando, FL, March 6-9, 2005. 

FDA (2003) Cypher Sirolimus-eluting coronary stent, summary of safety and effectiveness data. 

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