10.11.2004 – 18:25
Study Shows Low Incidence of Adverse Events Associated With Cypher(R) Sirolimus-Eluting Coronary Stent
New Orleans, November 10 (ots/PRNewswire)
- Analysis of 30 Adverse Event Risk Factors Offers New Insights for Patient Care
Data presented today at the 2004 American Heart Association Scientific Sessions further documented the low incidence of Major Adverse Cardiac Events (MACE) and stent thrombosis (blood clots) associated with the CYPHER(R) Sirolimus-eluting Coronary Stent. The overall MACE rate at six months for the drug-eluting stent was 3.1 percent in the 11,920 patients evaluated for the study, including men and women of different ages and ethnicities and with varying health status, including patients with diabetes.
MACE, which is a critical measurement of a drug-eluting stent's safety and efficacy, is a composite endpoint that typically includes such factors as target lesion revascularization (TLR, or the need for retreatment), myocardial infarction (heart attack), and death (all-cause mortality).
"These real-world clinical findings further support the significant scientific evidence that exists regarding the CYPHER(R) Stent. The results confirm an excellent safety profile of the CYPHER(R) Stent in routine clinical use, similar to that shown in randomized, controlled trials," said Philip Urban, MD, Director of Invasive Cardiology, La Tour Hospital, Geneva, Switzerland. "When it comes to any type of procedure, patient safety is always a primary concern for doctors and patients, so it is reassuring that the CYPHER(R) Stent is consistently demonstrating these positive results over time. The preliminary efficacy data are also very encouraging, even if a definitive assessment will have to wait until the 12-month follow-up data that should be available early next year"
Results from the analysis of 11,920 patients showed TLR at 1.3 percent and 1.0 percent had suffered a myocardial infarction. The aggregate stent thrombosis rate was 0.88 percent (0.13 percent acute thrombosis, 0.61 percent sub-acute thrombosis and 0.14 percent late thrombosis), which is comparable to conventional bare metal stents.
The study also examined 25 factors that could serve as predictors of a patient's likelihood to experience an adverse event after receiving a drug-eluting stent. Researchers looked at three main categories: clinical factors (e.g., age, presence of diabetes), lesion-specific factors (e.g., site of the lesion, such as in a bifurcated or left main vessel, amount of calcification) and procedure-specific factors (e.g., number of lesions, amount of residual restenosis).
"We found that patients with stable chest pain correlated with a decreased risk for adverse events, while factors such as insulin dependent diabetes, advanced age, and a history of open heart surgery showed a trend toward an increased risk of adverse events," Urban said.
Dennis Donohoe, MD, Vice President of Clinical and Regulatory Affairs at Cordis Corporation commented, "This study adds to the growing body of evidence regarding the CYPHER(R) Stent's strong safety profile, with new insight into factors that may impact patient outcomes."
The analysis was based on six-month follow-up data from the international e-CYPHER(SM) registry, which tracks use of the CYPHER(R) Stent in more than 15,000 patients worldwide. The e-CYPHER(SM) Registry has currently collected baseline, procedure and follow-up information from 15,000 patients treated in 281 centers. An independent review committee adjudicated all MACE events.
About the CYPHER(R) Stent
Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in more than 80 countries and has been used by doctors to treat more than 900,000 patients worldwide. With more than 40 clinical trials conducted or in progress worldwide, the CYPHER(R) Stent remains the most studied drug-eluting stent today with the largest body of clinical evidence demonstrating the long-term safety and efficacy of its drug and polymer. In clinical trials, the CYPHER Stent has been shown to reduce reblockage in the arteries by more than 90 percent over a bare metal stent.
About Cordis Corporation
For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. Today, more than 7,000 Cordis employees worldwide share a strong commitment to continue the Company's groundbreaking work in the fight against 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.
Web site: http://www.cordis.com
Terri Mueller, Cordis Corporation, +1-786-313-8687, or cell,
+1-305-903-9980; or Todd Ringler, Edelman, +1-212-704-4572, or cell,
+1-617-872-1235, for Cordis