A subgroup analysis of diabetic patient data from a two-year randomised controlled trial comparing the Cypher sirolimus-eluting coronary stent (Cordis) to the Taxus paclitaxel-eluting stent showed no statistically significant differences in safety outcomes between the two drug-eluting stents (DES). The analysis, presented at the European Society of Cardiology Congress 2007, by Dr Giulio Guagliumi, Ospedale Riuniti Di Bergamo in Bergamo, Italy, presented the results on behalf of the REALITY Trial investigators. "In this analysis of head-to-head randomised controlled trial data, both DES yielded similar safety outcomes and the Cypher group presented safety rates in some areas that were numerically lower," said Guagliumi.
The analysis involved 375 diabetic patients, which represented 28% of the patients enrolled in the REALITY Trial. The REALITY Trial was comprised of 1,386 moderately complex patients from 90 centres in Europe, Latin America and Asia. These patients were randomly selected to receive either the Cypher 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.
The cardiac death rates were 1.6% for the Cypher group and 4.7% for the Taxus group (p=0.14). The rate of Q-wave myocardial infarction was 0.0% for the Cypher group and 1.6% for the Taxus group (p=0.25). In addition, the rates of non-Q wave myocardial infarctions were 4.8% for the Cypher group and 5.2% for the Taxus group (p=1.00). None of these numerical differences in favour of the Cypher group reached statistical significance. Both DES 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 revascularisation. The MACE rate for the Cypher group was 15.5% while the MACE rate for the Taxus group was 14.1% (p=0.77).
The REALITY Trial investigators reported a stent thrombosis rate for the Taxus group that was significantly higher than the rate for the Cypher group in the overall patient population (2.5% for the Taxus group vs. 0.9% for the Cypher group; p=0.02). While the difference between the protocol-defined stent thrombosis rate for each DES 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 group (3.1% for the Taxus Stent vs. 1.1% for the Cypher group; p=0.16). These numerically lower rates of cardiac death, Q-wave myocardial infarction and stent thrombosis favouring the Cypher group 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 Dr David E Kandzari, Chief Medical Officer, Cordis. "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."
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