MIAMI, July 17 /PRNewswire/ -- A pooled analysis of five clinical trials found that patients requiring treatment with two or more overlapping stents for long artery blockages experienced better outcomes when receiving CYPHER(R) Sirolimus-eluting Coronary Stents than when receiving bare metal stents (BMS).
CYPHER(R) Stent patients had lower rates of re-blockage, lower rates of re-treatment and less arterial narrowing than patients receiving a bare metal stent. They also experienced a lower incidence of heart attacks and no increase in blood clots. The pooled analysis was published in a recent issue of the Journal of the American College of Cardiology.
“The pooled analysis is welcome news for physicians,” said Dean J. Kereiakes, M.D., F.A.C.C., Medical Director of The Heart Center of Greater Cincinnati and The Lindner Center for Research and Education at The Christ Hospital in Cincinnati. “This analysis suggests that when stent overlap is required, the CYPHER(R) Stent maintains exceptional safety and efficacy with no increase in the incidence of myocardial infarction [heart attacks] or stent thrombosis [blood clots] at the one-year follow-up. As stent overlap is a common event, these data provide important assurance to the interventional cardiology community regarding the safety of the CYPHER(R) Stent.”
According to the pooled analysis, patients treated with overlapping CYPHER(R) Stents had a myocardial infarction rate that was 38 percent lower at the 30-day follow-up (2.1 for the CYPHER(R) Stent versus 3.4 for BMS; p=0.43) and 52 percent lower at the one-year follow-up (2.2 for the CYPHER(R) Stent versus 4.6 for BMS; p=0.25), compared with those treated with BMS. In addition, CYPHER(R) Stent patients registered almost the same low rate of stent thrombosis than BMS patients at the one-year follow-up (0.4 percent for the CYPHER(R) Stent and 0.3 percent for BMS; p=1.00).
The pooled analysis also found that overlapping CYPHER(R) Stents were successful in reducing the incidence of re-treatment and re-blockage. At the one-year follow-up, rates of re-treatment (target lesion revascularization or TLR) were 83 percent lower in the CYPHER(R) Stent arm than for the BMS arm of the study (4.7 percent for the CYPHER(R) Stent versus 28.2 percent for BMS; p=<0.01). Similarly, eight-month follow-up by angiography found that the rates of restenosis (re-blockage) were 88 percent lower (6.2 for the CYPHER(R) Stent versus 50.6 for the BMS; p<0.01) for those treated with CYPHER(R) Stents than for those treated with BMS.
The pooled analysis examined three randomized (SIRIUS, E-SIRIUS and C-SIRIUS) and two non-randomized clinical trials (DIRECT and SVELT) and included a patient population of 575 patients, of which 337 patients were treated with overlapping CYPHER(R) Stents and 238 received overlapping BMS.
“The CYPHER(R) Stent was designed for the treatment of coronary artery disease in a broad range of patients, not just those with easy-to-treat lesions. This pooled analysis is a valuable piece of clinical evidence supporting the use of the CYPHER(R) Stent in this complex treatment situation,” said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation.
The pooled analysis was sponsored by Cordis Corporation.
The labeling for the CYPHER(R) Stent includes the following precautions for the use of multiple stents:
“The extent of the patient’s exposure to drug and polymer is directly related to the number of stents implanted. Use of more than two CYPHER(R) Stents has not received adequate clinical evaluation. Use of more than two CYPHER(R) Stents will result in the patient receiving larger amounts of drug and polymer than the experience reflected in the clinical studies.
“To avoid the possibility of dissimilar metal corrosion, do not implant stents of different materials in tandem where overlap or contact is possible. Potential interactions of the CYPHER(R) Stents with other drug-eluting or coated stents have not been evaluated and should be avoided whenever possible.
“It is noteworthy that there have been no prospective randomized trials specifically designed to assess multiple or overlapping CYPHER(R) Stents for long lesions in a single vessel. A retrospective analysis of subjects in randomized and non-randomized trials and clinical registries did not suggest an increased rated of myorcardial infarctions associated with the use of multiple or overlapping CYPHER(R) Stents in a single vessel, compared to that of bare-metal stents.”
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat more than 2 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 first next generation drug-eluting stent, the CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. In June 2006, CYPHER SELECT(TM) PLUS became the first third-generation drug-eluting stent to receive CE (Communite European) Mark approval. 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: Mariela Melendez of Cordis Cardiology, office: +1-786-313-2776,mobile: +1-786-218-4084, mmelen10@crdus.jnj.com; or Todd Ringler ofEdelman, office: +1-212-704-4572, mobile: +1-617-872-1235,todd.ringler@edelman.com