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).