SIRTAX LATE: Comparable outcomes for sirolimus-, paclitaxel-eluting stents at 5 years

Räber L. Circulation. 2011;123:2819-2828.

Issue: August 2011

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 2.25 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.

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