Two-Year Patient Registry Results Support Safety and Efficacy of Cypher Sirolimus-Eluting Coronary Stent in 'Real World' Uses
NEW ORLEANS, March 26, 2007 /PRNewswire/ -- A large patient registry of "real world" uses for the CYPHER(R) Sirolimus-eluting Coronary Stent reported favorable safety and efficacy outcomes at two-year follow-up, according to clinical investigators at the of Cardiology's 56th Annual Scientific Session (ACC.07).
The MATRIX Registry is a prospective, single-arm study designed to evaluate the outcomes of percutaneous coronary intervention (PCI or balloon angioplasty) with the CYPHER(R) Stent in everyday medical practice out to five years. Sponsored by Cordis Corporation, the registry reports on clinical data from 1,522 consecutive patients in whom the CYPHER(R) Stent was implanted, including high percentages of complex patient populations that are not currently within the approved labeling, such as patients with diabetes (33.8 percent), or history of heart attack (33.4 percent), balloon angioplasty (44.6 percent) or bypass surgery (21 percent). Overall, 86 percent of the interventions involved a specific patient or lesion characteristic not currently within the approved labeling for the CYPHER(R) Stent, and would be considered "off-label."
"The MATRIX Registry provides invaluable information to help physicians assess the long-term safety of the CYPHER(R) Stent in 'real world' patient populations," said Principal Investigator George D. Dangas, M.D., Ph.D., Associate Professor of Medicine, The Cardiovascular Research Foundation/Columbia University Medical Center, who presented the results.
In spite of the overall patient and lesion complexity, the MATRIX Registry indicated low frequency of adverse events with the CYPHER(R) Stent throughout the two years of patient follow-up. Applying the Academic Research Consortium (ARC) definition of stent thrombosis, the investigators reported a 0.7 percent rate of definite stent thrombosis and a 1.1 percent rate of definite/probable stent thrombosis. Total mortality and cardiac mortality was 3.3 percent and 1 percent, respectively. In addition, the rate for myocardial infarction (heart attack) was 4 percent, and the percentage of patients who required a second procedure to reopen the treated artery (target vessel revascularization or TVR) was 10.7 percent. These rates are comparable to the incidences found for the CYPHER(R) Stent in the randomized clinical trials that led to its regulatory approval in the United States.
"While randomized clinical trials offer the highest level of evidence, registries such as MATRIX play an important role in generating hypotheses and helping to monitor the outcomes of breakthrough therapies like the CYPHER(R) Stent in current clinical practice," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Cardiology Division, Cordis Corporation. "The MATRIX Registry adds to the growing body of evidence assessing the CYPHER(R) Stent, the most studied medical device in history, in complex patient populations."
The MATRIX Registry also showed no stent thrombosis or mortality differences between the off-label complex patient subgroups and the patient subgroups indicated to receive the CYPHER(R) Stent in the United States. In the off-label patient subgroup, the MATRIX Registry investigators reported a definite/probable stent thrombosis incidence of 1.1 percent, which was not statistically different from the 0.5 percent rate found in on-label patients (p=0.649). Likewise, the mortality rate for the off-label patients was 3.4 percent, which was not statistically different from the 2.7 percent rate in the on-label subgroup (p=0.519).
Dr. Dangas noted that the MATRIX Registry also found significantly higher rates of myocardial infarction or target vessel revascularization (TVR) in the complex patient subgroup compared to the rates seen in the on-label patient population. The myorcardial infarction rate for on-label patients was 0.9 percent versus 4.4 percent in the off-label patient arm (p=0.048). The TVR rate for on-label patients was 4.5 percent versus 11.6 percent in the off- label patient arm (p=0.040). "These findings are consistent with the overall clinical evidence, which shows complex patients to have higher event rates based on their complexity," he said.
The MATRIX Registry also tracked patient outcomes with dual anti-platelet therapy. According to the results, 75 percent of the patients included in the registry adhered to a prescribed dual antiplatelet therapy out to one year. However, such compliance did not result in significant differences in the rates of mortality, heart attack or stent thrombosis after one year compared to the outcomes of patients who stopped dual anti-platelet therapy before one year.
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat approximately three 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 70 studies 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 broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER(R) SELECT(TM) Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER(R) SELECT(TM) Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is 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.
*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.
Posted: March 2007