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NEVO[TM] Sirolimus-Eluting Coronary Stent Associated with Significantly Less Chest Pain at Six Months Than Taxus[R] Liberte[R] Stent.


Quality-of-Life Data, a First for a Drug-Eluting Stent In cardiology, a drug-eluting stent is a stent (a scaffold) placed into narrowed, diseased coronary arteries that slowly releases a drug to block cell proliferation. This prevents scar-tissue–like growth that, together with clots (thrombus), could otherwise block the stented , Presented at TCT TCT The Capital Times (Madison, WI newspaper)
TCT Transcatheter Cardiovascular Therapeutics
TCT The Coroner's Toolkit
TCT Trans Canada Trail
TCT Tcl Core Team
TCT Tsukuba College of Technology (Japan) 
 09

SAN FRANCISCO San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden  -- At six months, patients receiving the NEVO NEVO New Evolution (Tallinn, Estonia)
NEVO New Evolution in Home Control
([TM]) Sirolimus-eluting Coronary Stent sirolimus-eluting coronary stent Cardiology A coronary artery stent graft which has sirolimus, an imunosuppressive and antimitotic agent incorporated into its matrix, which significantly ↓ restenosis of stents.
See RAVEL.
 reported significantly less chest pain (also known as angina) than those receiving the Taxus([R]) Liberte([R]) Stent. Patients also reported improvements in their overall quality of life. These data demonstrate the important benefits of drug-eluting stents in reducing chest pain in patients with coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. .

This is the first time that quality-of-life measurements were included in a drug-eluting stent randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 controlled clinical trial controlled clinical trial,
n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo.
, reflecting Cordis Corporation's continued commitment to expanding the understanding of the clinical benefits of drug-eluting stents for patients with coronary artery disease.

Quality-of-life data from the NEVO RES I trial were released today at the Transcatheter Cardiovascular Therapeutics (TCT) 2009, the largest gathering of physicians focused specifically on interventional vascular treatments. These findings are particularly noteworthy given the increasing importance of quantifying quality-of-life outcomes measurements for interventional procedures as physicians and payors work to determine the optimal treatment options for patients amid an effort to control rising health care costs.

At six months, the Seattle Angina Questionnaire (SAQ SAQ Société des Alcools du Québec
SAQ Speed, Agility & Quickness (UK based movement training company)
SAQ Self Administered Questionnaire
SAQ Short Answer Question
SAQ Safety Attitudes Questionnaire
SAQ Self-Assessment Question
) demonstrated that patients receiving NEVO([TM]) experienced more freedom from patient-reported angina than those receiving the Taxus([R]) Liberte([R]) Stent (91.7 vs. 87.5; p-value =0.057), corresponding to 73% and 63% of patients being completely free of angina at 6 months (p=0.04). The SAQ is a statistically valid assessment tool that provides a reliable measure of several clinically relevant aspects of a patient's quality of life, such as physical limitation, angina stability, frequency of angina systems, a patient's satisfaction with treatment, and a patient's perception of how their coronary disease impacts their quality of life. In the NEVO RES I trial, patients completed the questionnaire when they were initially randomized and then one and six months after treatment.

"In this unique study, patients treated with NEVO([TM]) reported more relief from angina than patients treated with the Taxus([R]) Liberte([R]) Stent," said John Spertus, M.D., MPH, from the Saint Luke's Mid America Heart Institute, who presented the data. "While these are preliminary findings that need further confirmation, this study is significant because it is the first time we have begun including patient-reported outcomes into device trials. The inclusion of these outcomes will further define and validate the quality-of-life benefits of angioplasty for our patients."

Dr. Spertus developed the SAQ and is a leading expert in this emerging field of quality of life and assessment of response to therapy in medicine.

"The quality-of-life outcomes seen with NEVO([TM]) in this study are intriguing," said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. "We are exploring various hypotheses to better understand why NEVO([TM]) outperforms the Taxus([R]) Liberte([R]) Stent in this trial on both angiographic endpoints as well as why we see such favorable outcomes for several of the key quality-of-life measures included in this trial."

NEVO([TM]) is the first drug-eluting stent utilizing RES TECHNOLOGY([TM]), which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal 1. bare metal - New computer hardware, unadorned with such snares and delusions as an operating system, an HLL, or even assembler. Commonly used in the phrase "programming on the bare metal", which refers to the arduous work of bit bashing needed to create these basic tools  upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body.

in vi·vo
adj.
Within a living organism.



in vivo adv.
 data. By contrast, currently marketed drug-eluting stents, including the Taxus([R]) Liberte([R]) Stent, have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.

The SAQ is one of several quality of life measures included in the NEVO RES I clinical trial. The SF-12 Mental Component Scores showed a borderline significant improvement for NEVO([TM]) at six months (52.7 vs. 50.3; p=0.06) and the EQ-5D Visual Analog Scales also noted a trend in favor of NEVO([TM]) (76.7 vs. 73.2, p=0.08). There was no difference between NEVO([TM]) and the Taxus([R]) Liberte([R]) Stent in the SAQ physical limitation or treatment satisfaction scales or the SF-12 Physical Component Score.

Dr. Spertus is compensated for his time as the lead author of the quality of life portion of the NEVO RES I trial.

NEVO RES I Study Overview

The NEVO RES I study is a randomized, multi-center comparison of NEVO([TM]) to the Taxus([R]) Liberte([R]) Stent in de novo [Latin, Anew.] A second time; afresh. A trial or a hearing that is ordered by an appellate court that has reviewed the record of a hearing in a lower court and sent the matter back to the original court for a new trial, as if it had not been previously heard nor decided.  native coronary artery coronary artery
n.
1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and
 lesions. The study involved 394 patients at 40 sites throughout Europe, South America South America, fourth largest continent (1991 est. pop. 299,150,000), c.6,880,000 sq mi (17,819,000 sq km), the southern of the two continents of the Western Hemisphere. , Australia and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. . Patients received clinical follow-up at 30 days and six months and will be followed annually through five years.

Primary endpoint data from the NEVO RES I trial were presented at the EuroPCR meeting in May of this year. NEVO([TM]) not only met its primary endpoint of non-inferiority, but also demonstrated superiority to the Taxus([R]) Liberte([R]) Stent with respect to the primary endpoint of in-stent late lumen loss at six months. Specifically, late lumen loss was reduced by 64 percent in the NEVO([TM]) arm of the trial as compared to the Taxus([R]) Liberte([R]) arm (0.13 mm vs. 0.36 mm, p<0.001). In-stent late lumen loss, which represents the amount of tissue growth within a stent, reduces the diameter of the lumen, thus restricting blood flow through the stent. NEVO([TM]) also outperformed Taxus([R]) Liberte([R]) on a host of secondary endpoints, including stent thrombosis, target lesion target lesion Dermatology A lesion typical of erythema multiforme–EM in which a vesicle is surrounded by an often hemorrhagic maculopapule; EM is often self-limited, of acute onset, resolves in 3-6 wks, and has a cyclical pattern; EM lesions are 'multiform'  revascularization, target vessel revascularization, major cardiovascular adverse events, and angiographic in-segment binary restenosis.

Data from this trial will support a regulatory filing for a CE mark in countries outside the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. .

About the NEVO([TM] )Sirolimus-eluting Coronary Stent

NEVO([TM]) is made of cobalt chromium, which makes the stent flexible and conformable with thin struts A framework for writing Web-based applications in Java that supports the Model-View-Controller (MVC) architecture. Struts is deployed as JSP pages using special tags from the Struts tag library, which includes routines for building forms, HTML rendering, storing and retrieving data and  to maximize vessel coverage. The biodegradable polymer used to contain and release Sirolimus facilitates rapid endothelialization and results of pre-clinical studies indicated no greater inflammation than seen with bare metal stents. NEVO([TM]) is an investigational device. It is not yet approved or available for sale in any market.

NEVO([TM]) also contains the same drug, Sirolimus, as the CYPHER See cipher. ([R]) Sirolimus-eluting Coronary Stent, which has now been used in more than three million people worldwide. Data supporting the safety and efficacy of Sirolimus in coronary applications is now available out to six years, and this body of clinical evidence is completely unmatched by any other anti-restenotic stent.

About Cordis Corporation

For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.

*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune([R]). Rapamune is a trademark of Wyeth Pharmaceuticals.

**The third party trademarks used herein are trademarks of their respective owners.

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Date:Sep 24, 2009
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