NEVO? Sirolimus-Eluting Coronary Stent Associated with Significantly Less Chest Pain at Six Months Than Taxus Liberte Stent
Quality-of-Life Data, a First for a Drug-Eluting Stent, Presented at TCT 09
SAN FRANCISCO--(BUSINESS WIRE)--Sep 24, 2009 - At six months, patients receiving the NEVO™ Sirolimus-eluting Coronary Stent reported significantly less chest pain (also known as angina) than those receiving the Taxus® Liberte® 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.
This is the first time that quality-of-life measurements were included in a drug-eluting stent randomized controlled clinical trial, 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) demonstrated that patients receiving NEVO™ experienced more freedom from patient-reported angina than those receiving the Taxus® Liberte® 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™ reported more relief from angina than patients treated with the Taxus® Liberte® 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™ 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™ outperforms the Taxus® Liberte® 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™ is the first drug-eluting stent utilizing RES TECHNOLOGY™, 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 upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents, including the Taxus® Liberte® 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™ 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™ (76.7 vs. 73.2, p=0.08). There was no difference between NEVO™ and the Taxus® Liberte® 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™ to the Taxus® Liberte® Stent in de novo native coronary artery lesions. The study involved 394 patients at 40 sites throughout Europe, South America, Australia and New Zealand. 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™ not only met its primary endpoint of non-inferiority, but also demonstrated superiority to the Taxus® Liberte® 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™ arm of the trial as compared to the Taxus® Liberte® 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™ also outperformed Taxus® Liberte® on a host of secondary endpoints, including stent thrombosis, target lesion 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.
About the NEVO™ Sirolimus-eluting Coronary Stent
NEVO™ is made of cobalt chromium, which makes the stent flexible and conformable with thin struts 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™ is an investigational device. It is not yet approved or available for sale in any market.
NEVO™ also contains the same drug, Sirolimus, as the CYPHER® 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®. Rapamune is a trademark of Wyeth Pharmaceuticals.
he third party trademarks used herein are trademarks of their respective owners.
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Contact: Cordis Corporation
Posted: September 2009