Clinical investigators at the European Society of Cardiology Congress 2007 reported this week that Cordis’ Cypher sirolimus-eluting coronary stent continued to provide clinical benefits compared to a bare-metal stent in up to five years of follow-up with no differences in safety based on the results of an e-Sirius trial.
The five-year e-Sirius trial involved 352 patients from 35 European clinical centers, who were considered to be at moderate to high clinical risk for restenosis due to a previous heart attack or smoking, and compared the restenosis rates between the Cypher stent and a bare-metal stent.
The results demonstrated that 5.1 percent of the patients in the Cypher stent arm of the study underwent another procedure in the same arterial area, compared to 20.9 percent of the patients in the bare-metal stent arm of the study, meaning nearly 76 percent of the patients were less likely to require a second procedure in the same arterial area within five years.
The study also showed both treatment arms to yield similarly low rates of mortality (8.6 percent for the Cypher stent vs. 7.9 percent for the bare metal stent) and myocardial infarction (the non-Q-wave myocardial infarction rates were 7.4 percent for the Cypher stent vs. 5.1 percent for the bare-metal stent).
Another important finding yielded by the study is that researchers did not find a significant rate difference of stent thrombosis between the Cypher stent and the bare-metal stent.
The Miami Lakes, Fla.-based Cordis, a Johnson & Johnson subsidiary, developed and manufactures the Cypher stent.