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Two-Year Patient Registry Results Support Safety and Efficacy of,Cypher Sirolimus-Eluting Coronary Stent in 'Real World' Uses

rtality 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 perc
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