Two-Year Patient Registry Results Support Safety And Efficacy Of CYPHER® Sirolimus-Eluting Coronary Stent In "Real World" Uses
New Orleans, LA (March 26, 2007) – A large patient registry of “real world” uses for the CYPHER® Sirolimus-eluting Coronary Stent reported favorable safety and efficacy outcomes at two-year follow-up, according to clinical investigators at the American College 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® 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® 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® Stent, and would be considered “off-label.”
“The MATRIX Registry provides invaluable information to help physicians assess the long-term safety of the CYPHER® 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® 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 four 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® 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® 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® 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® 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.
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