Two-Year Outcomes From Large Head-To-Head Clinical Trial Indicate Similar Safety Profile In Diabetic Patients For CYPHER® Sirolimus-Eluting Coronary Stent And Taxus Stent

While no significant differences were found, results showed CYPHER® Stent had lower mortality and heart attack rates

Vienna, Austria . – A subgroup analysis of diabetic patient data from a two-year randomized controlled trial comparing the CYPHER® Sirolimus-eluting Coronary Stent to the Taxus Stent showed no statistically significant differences in safety outcomes between the two drug-eluting stents. The authors of the analysis, presented today at the European Society of Cardiology Congress 2007 (ESC Congress 2007), also reported that in the CYPHER® Stent arm there were numerically lower rates of cardiac mortality, 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, both drug-eluting stents yielded similar safety outcomes and the CYPHER® Stent presented safety rates in some areas that were numerically lower,” Giulio Guagliumi, M.D., from the Ospedale Riuniti Di Bergamo in Bergamo, Italy, who presented the results on behalf of the REALITY Trial investigators.

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

Both drug-eluting stents were also equivalent in terms of major adverse cardiac events (MACE), which in this study were defined to include cardiac deaths, Q-wave myocardial infarctions, non-Q wave myocardial infarctions, emergent bypass surgery and target lesion revascularizations (a subsequent procedure to reopen an artery). The MACE rate for the CYPHER® Stent was 15.5 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 investigators reported a stent thrombosis rate for the Taxus Stent that was significantly higher than the rate for the CYPHER® Stent in the overall patient population (2.5 percent for the Taxus Stent versus 0.9 percent for the CYPHER® Stent; p log-rank=0.02). While the difference between the protocol-defined stent thrombosis rate for each drug-eluting stent in the diabetic patient subgroup did not reach statistical significance, the rate for the Taxus Stent remained numerically higher than the rate for the CYPHER® Stent (3.1 percent for the Taxus Stent versus 1.1 percent for the CYPHER® Stent; p log-rank=0.16).

These numerically lower rates of cardiac death, Q-wave myocardial infarction and stent thrombosis favoring the CYPHER® Stent were also seen in diabetic patients who required insulin therapy.

“Diabetic patients remain one of the most complex patient populations to treat 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 analysis provides additional and relevant information to doctors regarding the long-term efficacy and safety outcomes in diabetic patients treated with either the CYPHER® Stent or the Taxus Stent.”

The analysis involved 375 diabetic patients, which represented 28 percent of the patients enrolled in the REALITY Trial. The REALITY Trial was comprised of 1,386 moderately complex patients from 90 centers in Europe, Latin America and Asia. These patients were randomly selected to receive either the CYPHER® Stent or the Taxus Stent. In the end, the CYPHER® Stent was used in 684 patients and 970 artery blockages, while the Taxus Stent was used in 669 patients and 941 artery blockages.

Cordis Corporation sponsored the REALITY Trial.