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news.Cordis has reported that in long-term, follow-up study, patients who have received the Cypher Sirolimus-eluting Coronary Stent for blockage of a bare metal stent were significantly less likely to need another procedure at three years compared to patients who received brachytherapy.
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The SISR trial is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the US. This longer-term, follow-up analysis focused on pre-specified safety endpoints, namely death, myocardial infarction and stent thrombosis, as well as target lesion revascularization (TLR), an efficacy endpoint, to determine whether any new safety issues emerged and whether the major benefit of the Cypher Stent, namely reduction in TLR, was maintained.
At three years, 81% of patients who received the Cypher Stent were free from a target lesion revascularization (TLR) compared to 71.6% of patients receiving brachytherapy (p=0.018). For target vessel revascularization, the survival free rates were 78.2% for the Cypher Stent and 68.8% for the brachytherapy arm (p=0.022).
David Holmes Jr., principal investigator of the study, said: “These data continue to favor the Cypher Stent compared to radiation therapy in these patients with complex coronary artery disease. Neither treatment modality in this study was associated with any new safety issues or concerns.”