News | March 17, 2010

Data Demonstrate Superior Performance of Drug-Eluting Stent

The CYPHER Sirolimus-eluting Coronary Stent

March 15, 2010 — Investigators reported the long-term follow-up of the largest randomized comparison between the two drug-eluting stents during the American College of Cardiology annual meeting this week in Atlanta.

The study highlighted the clinical differences between CYPHER Sirolimus-eluting Coronary Stent and Medtronic’s Endeavor Stent. The findings were also published on-line in the journal The Lancet. The CYPHER Stent was associated with significantly lower rates of death, myocardial infarction, and repeat revascularization than the Endeavor Stent out to 18 months.

The large randomized trial SORT OUT III included more than 2,300 patients across a wide range of lesion and patient complexity. The investigators reported that the mortality rate (4.4 for Endeavor vs. 2.7 percent for CYPHER), incidence of heart attacks (2.1 for Endeavor vs. 0.9 percent for CYPHER), and composite endpoint of MACE (9.7 for Endeavor vs. 4.5 percent for CYPHER) was significantly lower in patients receiving CYPHER compared to those receiving Endeavor.

The incidence of “definite” late stent thrombosis was higher for Endeavor than for CYPHER, but this difference was not statistically significant (1.1 for Endeavor vs. 0.5 percent for CYPHER). Coupled with the safety advantage observed with CYPHER, there was an efficacy advantage as well: CYPHER had significantly less frequent ischemia-driven target lesion revascularization through 18 months compared to Endeavor (1.7 for CYPHER vs. 6.1 percent Endeavor).

“The SORT OUT III data highlight the excellent long-term safety and efficacy data of the CYPHER Stent in a broad range of patients, and further show that there are important safety and efficacy differences between drug-eluting stents, in this case the CYPHER Stent and the Endeavor Stent,” said Campbell Rogers, M.D., chief scientific officer and head of global research and development for Cordis Corp.

There now have been six different sets of data from randomized clinical trials and registries — Endeavor III, SORT OUT III, ZEST, ISAR TEST II, the SCAAR diabetes data and the Western Denmark Registry — in which the CYPHER Stent outperformed the Endeavor Stent in key outcome measures, including in long term follow-up,” Dr. Rogers said.

The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER Stent in a broad range of patients.

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