New randomized trial data have indicated that patients
treated with first generation sirolimus-eluting stents
had no significant differences in clinical and angiographic outcomes at 5
years compared with patients receiving paclitaxel-eluting stents.
The Sirolimus-Eluting Versus Paclitaxel-Eluting Stents
for Coronary Revascularization (SIRTAX LATE) trial involved 1,012 patients
randomly assigned to receive either sirolimus-eluting stents (SES; Cypher,
Cordis; n=503) or paclitaxel-eluting stents (PES; Taxus, Boston Scientific;
n=509). In addition, all patients had at leastone lesion in a vessel with a
reference diameter between
and 4.00 mm.
At 5 years, 97.6% of SES and 96.1% of PES patients had
obtainable clinical follow-up. Major adverse cardiac events (a composite of
cardiac death, MI and
ischemia-driven target lesion revascularization) occurred in
19.7% of SES patients and 21.4% of PES patients (HR=0.89; 95% CI, 0.68-1.17).
Individually, there were no statistically significant differences in the rates
of cardiac death (SES, 5.8% vs. PES, 5.7%), MI (SES, 6.6% vs. PES, 6.9%) or
target lesion revascularization (TLR; SES, 13.1% vs. PES, 15.1%).
Also reported, the annual rate of TLR between 1 and 5
years was 2.0% for the SES group and 1.4% for PES group, while delayed lumen
loss for those undergoing paired angiography between 8 months and 5 years was
0.37 ± 0.73 mm for SES and 0.29 ± 0.59 mm for PES patients.
Among the clinical implications of the study, the
researchers wrote, were the low risk of repeat revascularization with
first-generation drug-eluting stents (DES) and the observation that very late
stent thrombosis remains an important limitation of first-generation DES,
accounting for more than half of all MIs between 1 and 5 years.