Investigators reported the long-term follow-up of the largest randomized comparison between the CYPHER® Sirolimus-eluting Coronary Stent and Medtronic’s Endeavor® Stent highlighting significant and sustained clinical differences. These important findings were presented at the American College of Cardiology annual meeting, (ACC 2010) in Atlanta and published on-line in the prestigious journal The Lancet. The CYPHER® Stent was associated with significantly lower rates of death, myocardial infarction (heart attack), and repeat revascularization (the need for another procedure) than the Endeavor® Stent out to 18 months. This study adds to the unmatched body of safety and efficacy data on the CYPHER® Stent with this comparison to the more recently approved Endeavor® Stent in a contemporary setting.
“We continue to be gratified by the outstanding performance of CYPHER® compared with other drug-eluting stents. The breadth of clinical safety and efficacy data and the long-term follow-up data on patient outcomes associated with the CYPHER® Stent are unmatched by the competition, and this gap continues to widen”
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% for CYPHER®: p<0.035), incidence of heart attacks (2.1% for Endeavor® vs. 0.9 % for CYPHER®: p<0.029), and composite endpoint of MACE (9.7 % for Endeavor® vs. 4.5 % for CYPHER®: p<0.0001) 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% for CYPHER®: p<0.13). 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% Endeavor®: p<0.0001).
“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, Global Research and Development, Cordis Corporation. “The superior safety and efficacy of the CYPHER® Stent compared to the Endeavor® stent in this real-world randomized study reinforce the excellent sustained clinical outcomes consistently seen over the last 10 years. 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 noted.
“We continue to be gratified by the outstanding performance of CYPHER® compared with other drug-eluting stents. The breadth of clinical safety and efficacy data and the long-term follow-up data on patient outcomes associated with the CYPHER® Stent are unmatched by the competition, and this gap continues to widen," Dr. Rogers concluded.