MIAMI, Feb. 2 /PRNewswire-FirstCall/ -- Results from a prospective, randomized clinical trial of small coronary vessels suggest that the CYPHER(R) Stent outperformed the Taxus Stent in three key endpoints that are utilized to assess efficacy: late lumen loss (primary endpoint), restenosis and target lesion revascularization (secondary). The ISAR-SMART Trial results appear today in the February issue of the European Heart Journal.
At 12 months follow-up, patients treated with the CYPHER(R) Stent demonstrated significantly better results than those patients treated with the Taxus Stent: In-stent late lumen loss in the Taxus Stent group was 0.56 +/- 0.59, compared to the CYPHER(R) Stent patient group 0.25 +/- 0.55 (p value= 0.001). Angiographic binary restenosis (greater than or equal to 50% diameter stenosis) was found in 19.0 percent of the lesions in the Taxus Stent group and 11.4 percent of the lesions in the CYPHER(R) Stent group (p value= 0.047). Furthermore, target lesion revascularization was conducted in 14.7 percent of the lesions treated with the Taxus Stent versus 6.6 percent of the lesions treated with the CYPHER(R) Stent (p value=0.008)
ISAR-SMART investigator and study author, Professor Adnan Kastrati, MD, Deutsches Herzzentrum in Munich, Germany, states that “based on the results of this study one would conclude that the Taxus Stent is associated with greater late lumen loss and is less effective in reducing restenosis in small coronary vessels than the CYPHER(R) Stent.”
Small vessel diameter has been identified as an important predictor of restenosis (reblockage) after treatment with a coronary stent. Studies such as the ISAR-SMART Trial provide a comparative view of drug-eluting stent performance in these challenging patient cases. The 360 patients in the study were randomly selected for treatment with either drug-eluting stent and had challenging blockages in vessels with an average diameter size of <2.80 millimeters. The CYPHER(R) Stent has also demonstrated positive results in other small vessel studies such as SES SMART, a randomized, multi-center prospective trial and SVELTE, a multi-center historical controlled study that assessed efficacy in treating small coronary vessels.
“The high standards of this independently conducted prospective, randomized study provide a true measurement of drug-eluting stent performance in this challenging patient population,” stated Dennis Donohoe, MD, Worldwide Vice President, Clinical and Regulatory Affairs, Cordis Corporation. “Positive clinical outcomes such as the ones seen in this trial and others are testament to sirolimus, the drug used on the CYPHER(R) Stent and its mechanism of action, which provide physicians with additional confidence in every case they treat. The ISAR-SMART Trial is one of nine randomized, controlled clinical trials that have demonstrated a statistically significant benefit of the CYPHER(R) Stent vs. the Taxus Stent and is another addition to the outstanding body of clinical evidence.”
The CYPHER(R) Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo (previously untreated) lesions of length < 30 mm in native coronary arteries with a reference vessel diameter of > 2.5 to < 3.5 mm.
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat more than 1.7 million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 40 studies, inclusive of independent clinical trials, that examine the performance of the CYPHER(R) Stent in a broad range of patients. Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in more than 80 countries and has the longest-term clinical follow-up of any drug-eluting stent. The CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent, which is the first next generation drug- eluting stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. More information about the CYPHER(R) Stent can be found at http://www.cypherusa.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company’s innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.
* 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.
Cordis Corporation
CONTACT: Media, Terri Mueller of Cordis Corporation, +1-786-313-8687, orCell: +1-305-903-9980, tmueller@crdus.jnj.com; or Todd Ringler of Edelman,Cell: +1-617-872-1235, todd.ringler@edelman.com