Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent

Tuesday, September 4, 2007 General News
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VIENNA, Austria, Sept. 4 A subgroup analysis of diabeticpatient data from a two-year randomized controlled trial comparing theCYPHER(R) Sirolimus-eluting Coronary Stent to the Taxus Stent showed nostatistically significant differences in safety outcomes between the two drug-eluting stents. The authors of the analysis, presented today at the EuropeanSociety of Cardiology Congress 2007 (ESC Congress 2007), also reported that inthe CYPHER(R) Stent arm there were numerically lower rates of cardiacmortality, blood clots and heart attack rates than in the Taxus Stent arm,although these differences did not reach statistical significance.

"In this analysis of head-to-head randomized controlled trial data, bothdrug-eluting stents yielded similar safety outcomes and the CYPHER(R) Stentpresented safety rates in some areas that were numerically lower," GiulioGuagliumi, M.D., from the Ospedale Riuniti Di Bergamo in Bergamo, Italy, whopresented the results on behalf of the REALITY Trial investigators.

The cardiac death rates were 1.6 percent for the CYPHER(R) Stent and 4.7percent for the Taxus Stent (p=0.14). The rate of Q-wave myocardialinfarction (heart attacks that involve the full thickness of the heart wall)was 0.0 percent for the CYPHER(R) Stent and 1.6 percent for the Taxus Stent(p=0.25). In addition, the rates of non-Q wave myocardial infarctions (heartattacks that do not involve the full thickness of the heart wall) were 4.8percent for the CYPHER(R) Stent and 5.2 percent for the Taxus Stent (p=1.00).None of these numerical differences in favor of the CYPHER(R) Stent reachedstatistical significance.

Both drug-eluting stents were also equivalent in terms of major adversecardiac events (MACE), which in this study were defined to include cardiacdeaths, Q-wave myocardial infarctions, non-Q wave myocardial infarctions,emergent bypass surgery and target lesion revascularizations (a subsequentprocedure to reopen an artery). The MACE rate for the CYPHER(R) Stent was15.5 percent while the MACE rate for the Taxus Stent was 14.1 percent(p=0.77).

At the World Congress of Cardiology 2006, the REALITY Trial investigatorsreported a stent thrombosis rate for the Taxus Stent that was significantlyhigher than the rate for the CYPHER(R) Stent in the overall patient population(2.5 percent for the Taxus Stent versus 0.9 percent for the CYPHER(R) Stent; plog-rank=0.02). While the difference between the protocol-defined stentthrombosis rate for each drug-eluting stent in the diabetic patient subgroupdid not reach statistical significance, the rate for the Taxus Stent remainednumerically higher than the rate for the CYPHER(R) Stent (3.1 percent for theTaxus Stent versus 1.1 percent for the CYPHER(R) Stent; p log-rank=0.16).

These numerically lower rates of cardiac death, Q-wave myocardialinfarction and stent thrombosis favoring the CYPHER(R) Stent were also seen indiabetic patients who required insulin therapy.

"Diabetic patients remain one of the most complex patient populations totreat for coronary artery disease," said David E. Kandzari, M.D., F.A.C.C.,F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "This analysisprovides additional and relevant information to doctors regarding the long-term efficacy and safety outcomes in diabetic patients treated with either theCYPHER(R) Stent or the Taxus Stent."

The analysis involved 375 diabetic patients, which represented 28 percentof the patients enrolled in the REALITY Trial. The REALITY Trial wascomprised of 1,386 moderately complex patients from 90 centers in Europe,Latin America and Asia. These patients were randomly selected to receiveeither the CYPHER(R) Stent or the Taxus Stent. In the end, the CYPHER(R) Stentwas used in 684 patients and 970 artery blockages, while the Taxus Stent wasused in 669 patients and 941 artery blockages.

Cordis Corporation sponsored the REA

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