Cordis Reports 6-Year SIRIUS Data for Cypher at CRT

March 5, 2009—Cordis Corporation (Warren, NJ) announced that the 6-year follow-up data of the study comparing the clinical benefits of the company's Cypher sirolimus-eluting coronary stent and a bare-metal stent (BMS) were presented at the CRT 2009: Cardiovascular Research Technologies conference in Washington, DC. Cordis's SIRIUS (Sirolimus-coated BX Velocity Balloon-Expandable Stent in Treatment of Patients With De Novo Coronary Artery Lesions) trial served as a pivotal study for the US approval of the Cypher stent in 2003. In the double-blind, multicenter, randomized trial, patients were divided into two treatment groups: 533 patients received the Cypher stent and 525 patients received a BMS. Of the original 1,058 participants, approximately 50% of patients (271 Cypher and 255 BMS patients) participated in the 6-year follow up.

According to the company, the SIRIUS trial results demonstrated that the comparative benefits shown in earlier reported follow-up data were sustained at 6 years. In addition, no differences were observed between the Cypher stent and the BMS in the occurrence of myocardial infarction, death, or stent thrombosis.

At 6-year follow-up, patients who received the Cypher-stent in the SIRIUS trial experienced significantly lower rates of target vessel failure, the primary endpoint of the trial, than those who received the BMS (26.1% for Cypher vs 39.9% for BMS; P < .0001). Target vessel failure was defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization. The Cypher stent also demonstrated lower rates of target lesion revascularization (11.9% for Cypher vs 27.9% for BMS; P < .0001) and major adverse cardiac events, which include myocardial infarction and death (22.6% for Cypher vs 37.2% for BMS; P < .0001). These 6-year outcomes support the previously reported results of the trial and show no signs of late catch-up, the company stated.

In addition, there was no significant difference in the mortality rate (8.9% for Cypher vs 9.4% for BMS; P = .974) or the myocardial infarction rate (6.4% for Cypher vs 7% for BMS; P = .774) between the two groups at 6-year follow-up. There was no significant difference in the overall rate of stent thrombosis as defined by both the original SIRIUS Trial protocol definition (1.2% for Cypher vs 0.8% for BMS; P = .536) and the definite/probable Academic Research Consortium definition (1.2% for Cypher vs 2.1% for BMS; P = .304). There was no trend toward an increase in Academic Research Consortium-defined definite or probable very late stent thrombosis rates between 1 and 6 years (0.8% for Cypher vs 1% for BMS), Cordis reported.

The following stories are from presentations at the American College of Cardiology's 58th annual scientific session and the concurrent Innovation in Intervention: i2 Summit held March 28-31, 2009 in Orlando, Florida.