CHICAGO—Patients who received the Cypher sirolimus-eluting coronary stent for blockage of a bare metal stent were significantly less likely to need another procedure, including target lesion revascularization (TLR) at three years compared to patients who received brachytherapy, according to long-term, follow-up data presented at the SCAI-ACCi2 Summit during the 2008 American College of Cardiology (ACC) Scientific Sessions.
The SISR Trial (A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis within Bare Metal Stents) is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the United States, according to the company.
Cordis said that the trial was designed for follow-up at nine months, a longer-term, follow-up analysis that focused on pre-specified safety endpoints, namely death, MI and stent thrombosis, as well as an efficacy endpoint TLR to determine whether any new safety issues emerged.
“These data continue to favor the Cypher stent compared to radiation therapy in these patients with complex coronary artery disease,” said David R. Holmes Jr., MD, principal investigator and professor of medicine at the Mayo Clinic College in Rochester, Minn. “Neither treatment modality in this study was associated with any new safety issues or concerns.” Holmes also serves as an advisory board member to Cordis’ e-SELECT registry, which is being conducted outside the United States.
At three years, 81 percent of patients who received the Cypher were free from a TLR compared to 71.6 percent of patients receiving brachytherapy, the company said. For target vessel revascularization, Cordis said that the survival free rates were 78.2 percent for the Cypher stent and 68.8 percent for the brachytherapy arm.
The stent thrombosis rates, as defined as definite and probable per the Academic Research Consortium (ARC) definitions, were not significantly different (3.7 percent for the Cypher Stent vs. 2.6 percent for brachytherapy), the company reported.
Although three year rates of target vessel failure (the Cypher stent, 75.1 percent; brachytherapy, 67.9 percent) and major adverse cardiac events (MACE) were both improved with the Cypher stent, this did not reach statistical significance, likely reflecting progression of coronary artery disease at sites other than the original location of bare metal stent restenosis, Cordis said. The company also reported that rates of MACE were 75.5 percent for the Cypher stent and 70.5 percent for brachytherapy.
The Cypher stent does not have an approved indication for the treatment of in-stent restenosis in the United States.
Cordis, a Johnson and Johnson company, sponsored the trial.