Cypher Stent Research Articles

Primary Percutaneous Coronary Intervention With Drug-Eluting Stents

Primary percutaneous coronary intervention (P-PCI) is the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction if it can be performed rapidly by an experienced team.1 Compared with balloon angioplasty, routine bare-metal stent (BMS) implantation decreases risk for target vessel revascularization (TVR) and possibly reduces myocardial reinfarction rates but does not reduce mortality rates.2,3 Therefore, BMS has become the dominant P-PCI strategy, despite initial concern about increased stent thrombosis rates from delayed healing or inadequate late stent apposition due to initial thrombus trapping. Less established is the role of drug-eluting stents (DES) in P-PCI. DES have the potential to further decrease TVR rates but may increase risk for stent thrombosis. In fact, the risk of stent thrombosis might even be higher in P-PCI than in electively treated patients because of the combination of increased platelet activation, delayed healing, lack of endothelialization, and the proinflammatory and prothrombotic environment in the infarct artery.4 Article see p 103 Several relatively small randomized clinical trials have shown inconsistent efficacy for DES over BMS for P-PCI. Three meta-analyses of these trials have concluded that there is no difference in death or myocardial infarction rates, but TVR rates are decreased.5–7 Variably included were 12 studies that differed in trial design, inclusion criteria, end-point definitions, stent types, duration of clopidogrel treatment, and type of follow-up (angiographic versus clinical). They were limited by sample size and duration of follow-up and usually required angiographic documentation of stent thrombosis, which may have underestimated its true incidence. In this issue of Circulation: Cardiovascular Interventions , Kukreja et al8 report a single-center registry study that is an expanded version of a previous publication.9 Again including the 185 ST-segment elevation myocardial infarction patients treated with Sirolimus-eluting stents (SES) from April 2002 to February 2003, they compare …

Novel bioabsorbable salicylate‐based polymer as a drug‐eluting stent coating

Permanent polymers used in current drug-eluting stents (DES) can trigger chronic inflammation and hypersensitivity reactions, which may contribute to the increased risk of late thrombosis and rebound restenosis. Therefore, optimal polymer selection and the use of completely absorbable but biocompatible polymers are expected to minimize these risks. We sought to evaluate a novel, potentially innately anti-inflammatory, bioabsorbable salicylate-based polymer as a DES coating, in a clinically relevant animal model. Four types of stents were implanted in pig coronary arteries using QCA to optimize stent apposition: bare metal stents (BMS); salicylic acid/adipic acid bioabsorbable polymer-only coated metal stents (SA/AA); biostable polymeric sirolimus-eluting stents (Cypher); and metal stents coated with salicylic acid/adipic acid bioabsorbable polymer containing sirolimus (SA/AA + S). The dose density of sirolimus was 8.3 microg/mm of stent length (similar to Cypher) with in vitro studies demonstrating elution over 30 days and complete polymer degradation in 37 days. Animals underwent angiographic restudy and were terminated at 1 month for complete histopathologic and histomorphometric analyses. Both SA/AA + S and Cypher stents had significantly lower angiographic % stenosis when compared with BMS and SA/AA polymer-only groups (6 +/- 4% and 5 +/- 4% vs. 15 +/- 7% and 16 +/- 5%, respectively, P < 0.001). Intimal thickness was lower for SA/AA + S and Cypher than for BMS (0.14 +/- 0.06 and 0.13 +/- 0.04 mm vs. 0.23 +/- 0.05 mm, respectively, P < 0.001). Histologic % area stenosis was also lower for SA/AA + S and Cypher when compared with BMS (22 +/- 7% and 23 +/- 6% vs. 33 +/- 5%, respectively, P < 0.001). There was a strong trend toward reduced inflammatory response in the SA/AA and SA/AA + S when compared with BMS and Cypher groups (P = 0.072). This study shows favorable vascular compatibility and efficacy for a novel bioabsorbable salicylate-based polymer as a DES coating, and supports further research and development of this unique class of polymer materials for applications in cardiovascular devices.

Novel anti-inflammatory salicylate-based bioabsorbable drug-eluting polymeric stent coating

Background: Permanent polymers used in current drug-eluting stent (DES) can trigger inflammatory reactions contributing to increased risk of late thrombosis and rebound restenosis. Optimal polymer selection and the use of completely absorbable polymers are expected to minimize these risks. Aim: To evaluate a novel potentially innately anti-inflammatory, salicylatebased bioabsorbable polymer eluting sirolimus in a clinically relevant animal model. Methods: Four different types of stents (n=36) were implanted in coronary arteries of 12 pigs using QCA to optimize stent apposition: bare metal stents (BMS); salicylic acid/adipic acid bioabsorbable polymer-only coated stents (SA/AA); Cypher stents; and metal stents coated with salicylic acid/adipic acid bioabsorbable polymer containing sirolimus (SA/AA+S). Dose density of sirolimus was 8.3 μg/mm of stent length, with in vitro studies demonstrating elution over 30 days and complete polymer degradation in 4–6 weeks. Animals were terminated at 1 month after angiographic restudy, for histopathologic and histomorphometric analyses. Results: Both SA/AA+S and Cypher stents had significantly lower angiographic % stenosis than BMS and SA/AA polymer-only groups (6±4% and 5±4% vs. 15±7% and 16±5%, respectively, Pb.001). Intimal thickness was lower for SA/AA+S and Cypher than for BMS (0.14±0.06 and 0.13±0.04 vs. 0.23±0.05 mm, respectively, Pb.001). Histologic % area stenosis was also lower for SA/AA+S and Cypher than for BMS (22±7% and 23±6% vs. 33±5%, respectively, Pb.001). The inflammatory reaction to SA/AA and to SA/AA+S was mild, whereas inflammation in BMS and Cypher tended to be more pronounced (P=.072). Conclusions: This study showed favorable vascular compatibility and efficacy of a novel anti-inflammatory salicylate-based biodegradable polymer eluting sirolimus. Since there is a tendency for reduced vessel wall inflammatory response and this polymer is fully absorbable, there may be significant improvement over existing DES to avoid late stent thrombosis.

Coronary stent disease: When will enough be enough?

CLINICAL SUMMARY A 60-year-old man was transferred to the Sir Charles Gairdner Hospital with unstable angina. His comorbidities were obesity (body mass index 33.6 kg/m), hypertension, type II diabetes mellitus requiring insulin, hypercholesterolemia, and chronic renal failure (creatinine 150 mmol/L) due to diabetic nephropathy. The patient was an ex-smoker. Left ventricular ejection fraction was 45% with hypokinesis of the inferolateral wall. He had severely diseased left anterior descending (LAD) and left circumflex (LCx) coronary arteries with multiple in-stent stenoses (Figure 1) and a small nondominant right coronary artery. The patient had been previously managed elsewhere. In March of 2002, he was admitted with unstable angina and underwent percutaneous transluminal coronary angioplasty (PTCA) of the obtuse marginal (OM) branch. During angioplasty, the OM branch was dissected. A 2.5-mm Tsunami stent (Terumo Corporation, Tokyo, Japan) and a 2.5-mm Pixel stent (Guidant, Santa Clara, Calif) were placed to overlap the area of dissection. In October of 2002, unstable angina and in-stent stenosis of the OM developed, which were managed by PTCA alone. In May of 2003, unstable angina recurred. The patient underwent repeat PTCA to the LAD and LCx arteries, during which 3 Cypher stents (Cordis Corporation, Warren, NJ) were placed in the proximal LAD occluding the second diagonal branch and 4 Zeta stents (Abbott Laboratories, Abbott Park, Ill) were placed in the LCx. In January of 2007, the patient presented with unstable angina, inferolateral myocardial infarction, and pulmonary edema. The in-stent stenosis in the distal LCx was demonstrated, and the flow was restored with 4 Cypher stents. In March of 2007, he presented again with a prolonged episode of angina and inferolateral infarction and was found to have

Outcomes of the tacrolimus drug-eluting Janus stent: a prospective two-centre registry in high-risk patients

To date, only two drug-eluting stents (DES) have been extensively tested in both randomized controlled clinical trials and large 'real world' registries: sirolimus-DES (Cypher stent, Cordis, Miami Lakes, Florida, USA) and paclitaxel-DES (Taxus stent, Boston Scientific, Natick, Massachusetts, USA). Recently, a new polymer-free tacrolimus-eluting Carbofilm-coated stent, the Janus stent (Sorin Biomedica, Saluggia, Italy), has entered the market but only few clinical data testing its safety and efficacy in selected patients are available. Thus, we performed a prospective registry of consecutive, unselected patients receiving this new DES. A total of 118 patients scheduled for percutaneous coronary intervention (PCI) with DES were enrolled in two separate centers. End-points were: (i) immediate angiographic failure; (ii) major adverse coronary events (MACE) defined as the composite of cardiovascular death, nonfatal myocardial infarction (MI) and target lesion revascularization (TLR); (iii) clinically driven TLR; (iv) and stent thrombosis at 6-month follow-up. A total of 192 Janus stents were successfully implanted during elective (36%) or urgent PCIs (64%), including patients with ST elevation MI (16%). Twenty-four percent of patients were diabetics and 27% underwent multivessel PCI. Target lesions were B2-C type in 54%, in-stent restenosis in 8%, and located in degenerated venous grafts in 9%. Angiographic failure was observed in five of the 147 (3.4%) lesions treated. Total MACE rate at 6-month follow-up was 22% and clinically-driven TLR was carried out in 14% of patients. Stent thrombosis occurred in 4% of cases. This registry of the new tacrolimus-eluting Carbofilm-coated Janus stent showed an incidence of MACE, TLR and stent thrombosis higher than that reported in previous similar studies on DES. Whether this risk is due to this specific device or to the unselected (i.e. high-risk) population warrants further research.

Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: The Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial

Patients with diabetes have increased risk of in-stent restenosis after coronary stent implantation owing to neointimal hyperplasia (NIH). The aim of the study was to evaluate the extent and distribution of NIH with intravascular ultrasound (IVUS) after coronary artery stenting with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in diabetic patients. One hundred and thirty diabetic patients were randomized to Cypher or Taxus stent implantation. IVUS was performed at 8 month follow-up. NIH volume was significantly reduced in the Cypher group when compared with the Taxus group: median (inter-quartile range) 0.0 (0.0-0.0) vs. 8.0 mm(3) (0.1-33.0), P < 0.001. Per cent NIH volume was also significantly lower in Cypher stents compared with Taxus stents: median (inter-quartile range) 0.0 (0.0-0.0) vs. 7.5% (0.1-27.0), P < 0.001. NIH was covering 5.4% of the stent length in the Cypher stents compared with 46.1% in the Taxus stents (P < 0.001). The incidence of diffuse NIH was significantly higher for Taxus than for Cypher stents (42.9 vs. 3.5%, P < 0.001). Taxus stents had more often NIH at the proximal stent edge compared with Cypher stents (45.1 vs. 7%, P < 0.001) and no Cypher stents had NIH at the distal stent edge compared with 35.5% of the Taxus stents (P < 0.001). In diabetic patients, the Cypher stent, compared with the Taxus stent, inhibited NIH more effectively and had a more focal NIH pattern including less involvement of the stent edges.

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry

Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine. The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03). This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.

First clinical comparison of Nobori –Biolimus A9 eluting stents with Cypher– Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes

To compare clinical efficacy and safety of stents eluting limus drugs from biodegradable polymer - Nobori, or durable polymer - Cypher. From May to August 2006, 107 patients with 142 coronary artery lesions were treated with either Nobori, Biolimus A9 eluting stent (54) or Cypher, Sirolimus eluting stent (53) in five centres. The two groups were well matched for baseline clinical and angiographic characteristics. The in-stent late loss at nine months, the primary endpoint of the study, was 0.10+/-0.26 mm in Nobori, and 0.13+/-0.44 mm in Cypher arm (p=0.660) confirming the hypothesis of the similarity between the two stents. In-stent diameter stenosis of 13+/-10% with Nobori was significantly lower than 20+/-12% with Cypher stent (p=0.002) without significant difference in binary restenosis (1.7% in Nobori and 6.3% in Cypher arm; p=0.32). The rate of major adverse cardiac events at 12 months was 1.9% with Nobori and 4.1% with Cypher stent. The nine months angiographic data from Nobori Core study demonstrate that Biolimus A9 has similar anti-proliferative efficacy to Sirolimus as judged by in-stent late loss and restenosis rate. Low frequency of adverse cardiac events at 12 months indicates that both stents are safe and effective in the studied population.

Higher incidence and serum levels of minor cardiac biomarker elevation in sirolimus-eluting stent (Cypher) than bare metal stent implantations

Minor cardiac biomarker elevation after percutaneous coronary intervention has long-term prognostic significance. The sirolimus-eluting stent (Cypher) has been reported to require high postinflation pressure for optimal implantation. We examined the incidence of minor cardiac biomarker elevation induced by Cypher implantation. We measured the serum concentration of cardiac troponin-I (cTnI) 24 h after stenting and those of creatine kinase isoenzyme MB and creatine kinase before, immediately after, and 6, 12 and 24 h after implantation in patients who underwent Cypher stent (CS group; n=53) or bare metal stent (BMS group; n=57) implantation. No significant difference in clinical background was observed between the two groups. When a cutoff cTnI value of 0.50 ng/ml was used, the CS group showed a significantly higher incidence of cTnI elevation (35.8%, 19/53) than the BMS group (14.0%, 8/57) (P<0.05). Similarly, the incidence of cTnI > or = 0.03 ng/ml tended to be higher in the CS group (88.7%, 47/53) than in the BMS group (73.7%, 42/57: 0.05<P<0.10). Furthermore, the CS group showed significantly higher cTnI levels than the BMS group (1.32+/-2.38 vs. 0.34+/-0.91 ng/ml. P<0.001). Essentially, similar results were obtained for serum creatine kinase isoenzyme MB and creatine kinase. Among clinical, lesion and procedural characteristics, postinflation pressure for stenting was significantly higher only in the CS group (18.2+/-2.8 atm) than in the BMS group (14.0+/-2.7 atm) (P<0.001). The results demonstrated that CS implantation increases the incidence of minor cardiac biomarker elevation compared with BMS. The difference in postinflation pressure could account for the results.

Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitäts Trial (BASKET) outcome data, we hypothesized that very late (> 12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. To prove or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with > or = 3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only patients with left main or bypass graft disease, in-stent restenosis or stent thrombosis, in need of nonheart surgery, at increased bleeding risk, without compliance/consent are excluded. All patients are treated with dual antiplatelet therapy for 12 months. The primary end point will be cardiac death/nonfatal myocardial infarction after 24 months with further follow-up up to 5 years. By June 12, 229 patients (10% of the planned total) were included with a baseline risk similar to that of the same subgroup of BASKET (n = 588). This study will answer several important questions of contemporary stent use in patients with large native vessel stenting. The 2-year death/myocardial infarction-as well as target vessel revascularization-and bleeding rates in these patients with a first- versus second-generation drug-eluting stent should demonstrate the benefit or harm of these stents compared to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12- versus 6-month dual antiplatelet therapy on these outcomes.

Understanding the different pattern of in-stent restenosis between sirolimus-and paclitaxel-eluting stents; still long way to go

We thank for Dr. Celik's sincere comments on our recent paper [ [1] Park C.B. Hong M.K. Kim Y.H. et al. Comparison of angiographic patterns of in-stent restenosis between sirolimus-and paclitaxel-eluting stent. Int J Cardiol. 2007; 120: 387-390 Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar ]. In spite of recent hot issue about stent thrombosis, in-stent restnosis (ISR) is one of most important issues in drug-eluting stents (DES) era. Prior studies made progress the pathogenesis and causes of ISR but not so much known to those of ISR pattern between Cypher (Cordis corporation, Miami, FL) and Taxus (Boston scientific, Natric, MA) stent. So far, several possible explanations about different ISR pattern in Cypher and Taxus stent exist, as stated by Celik et al., but have flaws on each explanation as well.

Long-term Outcomes of Percutaneous Therapy for True Bifurcation Lesions Treated with Drug-eluting Stents Using the “Shunt” Technique

405 Long-term Outcomes of Percutaneous Therapy for True Bifurcation Lesions Treated with Drug-eluting Stents Using the “Shunt” Technique Pratap Shetty ∗, Nigel Jepson, Robert Giles, Daniel Friedman, Warren Walsh, Roger Allan, Mark Pitney Prince of Wales Hospital, Randwick, NSW, Australia Background: A standardised two stent technique, (“shunt stenting”) has been usual practice for treating true bifurcation lesions involvingmajor side branches (>2.25mm) at our institution. We report procedural and follow up data on the first 254 patients. Methods: Database data collection on all PCI lesions and procedures is collectedprospectively at our institution.We reviewed procedural details between November 2002 and January 2008. Follow-up was obtained through telephone interview and clinical review. Results:Out of 442 bifurcations treated, 254 were “shunt” stented. 75.6% were males with a mean age of 62.1 years. Acute coronary syndrome (53.2%) was the most common indication for angioplasty. Glycoprotein IIb/IIIa inhibitor was used in 44.9%. The commonest lesion was LAD/Diagonal (66.1%). Cypher stents were used in 80%, Taxus in 10%. The average stent diameter used was 2.84mm (main branch) and 2.53mm (side branch). Procedural success with no MACE was obtained in 99.6% o t a

Functional Formula to Determine Adequate Balloon Diameter of Simultaneous Kissing Balloon Technique for Treatment of Bifurcated Coronary Lesions Clinical Validation by Volumetric Intravascular Ultrasound Analysis

Final kissing balloon technique (KBT) is known to alter long-term clinical outcomes for treatment of bifurcated coronary lesions. However, determination of adequate diameters of the 2 balloons remains difficult because of lack of a working index. Twenty-one cases of left main (LM)-related bifurcated lesions, treated with Cypher(TM) stents (single/crush stenting) and final KBT, were enrolled. The formula "R(2) = D(1)(2) + D(2)(2)" was used, adjusting balloon diameter (D(1), D(2)) to the downstream branches, to predict the theoretical mean hugging balloon diameter (R) within the main portion. The degree and pattern of stent expansion in the LM and main branch (MB) segments was compared by volumetric intravascular ultrasound assessment. Stents in the LM segments expanded to a greater extent and more asymmetrically than in MB segments (average stent area: 13.2+/-3.1 mm(2) vs 7.6+/-2.1 mm(2), p<0.0001, stent symmetry index: 0.77+/-0.08 vs 0.88+/-0.03, p<0.0001). The actual mean stent diameter significantly correlated with R (p=0.0003, r=0.76). The ratio of actual to theoretical stent expansion was highly consistent between the LM and MB (93.1% vs 93.4%, p=NS). The proposed formula may be useful for predicting resultant stent expansion following KBT, despite a more elliptical dilation.

Clinical Safety of Drug-Eluting Stents in the Korea Acute Myocardial Infarction Registry

Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may be useful in patients with acute myocardial infarction (AMI), but safety issues still need to be solved. This study was undertaken to investigate the incidence of major adverse cardiac events (MACE) and stent thrombosis in DES-implanted AMI patients in real-life clinical practice. On-line registry of AMI cases at the web site www.kamir.or.kr has been performed in 41 primary PCI centers in Korea and between November 2005 and September 2006, 1,541 surviving patients who had been implanted with either Cypher or Taxus stents were enrolled for analysis during a 6-month clinical follow-up. There were 2 groups: group I [834 patients, 61.9+/-11.9 years: sirolimus-eluting stent (Cypher)], group II [707 patients, 62.9+/-12.0 years: paclitaxel-eluting stent (Taxus)]. At both 1 and 6 months the incidence of MACE was not significantly different between the 2 groups. There were 17 cases of stent thrombosis, but the incidence of stent thrombosis was not significantly different between the 2 groups (group I:II=9 (1.1%):8 (1.1%), p=1.000). The stent type, length, number, lesion complexity and diabetes were not significant for the incidence of MACE or stent thrombosis after adjustment. MACE and stent thrombosis rates did not differ between 2 types of DES identified in Korea Acute Myocardial Infarction Registry (KAMIR). DES can be used in patients with AMI with a relatively low 6-month MACE rate.

The CYPHER® Stent Receives the CE Mark for Acute Myocardial Infarction

Cordis Corporation recently announced that it has received CE mark approval for the treatment of acute myocardial infarction (AMI) using the CYPHER® SELECT™ PLUS sirolimus-eluting coronary stent. CE marking means conformity to the applicable European Directive, and in the specific context of AMI permits the CYPHER stent to be placed on the market for treatment of AMI in all Member States of the EU, the European Economic Area and Switzerland.

Early Results of a Randomised Trial of Bifurcation Stent Implantation with Cypher Stents Comparing “Shunt Stent” to the Provisional T Stent Technique: The REWIRE Trial

Background: This study compares our two-stent technique (shunt stent) with provisional T stenting. In view of increasing published data favouring a single stent strategy, it was elected to review mid term results of the trial for safety.

Very Late Stent Thrombosis after Drug-Eluting Stent Implantation in a Patient without Aspirin and Clopidogrel Resistance

Very late stent thrombosis (VLST) after implantation of drug-eluting stent is rare, but very fatal complication after percutaneous coronary intervention. We report a case of VLST of a sirolimus-eluting Cypher™ stent (Cordis, Johnson and Johnson) presenting as acute ST elevation myocardial infarction at 26 months after deployment with continued combined dual antiplatelet medication of aspirin and clopidogrel. The patient did not show anti-platelet resistance.

Sirolimus eluting stent (Cypher™) in patients with diabetes mellitus: results from the German Cypher Stent Registry

Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary. 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS). The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.

Sirolimus-eluting stents in the treatment of chronic total coronary occlusions

We assessed the effectiveness and safety of the sirolimus-eluting stent (SES) in the treatment of chronic total coronary occlusions. Chronic total occlusions (CTO) of coronary vessels have an unacceptable high restenosis rate of approximately 50% after stenting. Few data exist about the performance of drug eluting stents (DES) in the treatment of CTO. All coronary interventions using the Cypher stent performed at 122 centers engaged in the German Cypher registry between April 2002 and December 2004 were analyzed; a total of 5,344 patients; 374 with and 4,970 without CTO were compared. There was no significant difference between both groups regarding demographics, coronary status and left ventricular function. Patients in the CTO group had a higher level of angina symptoms, the coronary lesions were more complex and the stents used were smaller and longer than in the No-CTO group. The In-hospital outcome was similar in both groups, with importantly no difference regarding mortality and complications. Stenting was as successful in the CTO as in the No-CTO group; during a follow-up of 6.6 months we found no significant difference regarding the rate of mortality, complications, and revascularization between both groups. Implantation of the Cypher stent reduces the restenosis rate and seems to be a safe and effective tool for the treatment of chronic total coronary occlusions.