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Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents: 1-Year Outcomes From the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET)
Study Questions:
What is the comparative efficacy of the everolimus-eluting stent (EES) compared with the sirolimus-eluting stent (SES)?
Methods:
The authors reported the results of the RESET (Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial). This was a prospective, multicenter, randomized open-label trial that enrolled 3,197 patients in Japan and randomly assigned them to receive either EES (1,597 patients) or SES (1,600 patients). The primary endpoint of the trial was target vessel revascularization.
Results:
There was no difference in the target lesion revascularization (TLR) rate in the two arms (EES 4.3% vs. SES 5.0%). Stent thrombosis rate was low and similar (0.32% vs. 0.38%, p = 0.77). The angiographic substudy enrolling 571 patients (EES: 285 patients, and SES: 286 patients) demonstrated noninferiority of EES relative to SES regarding in-segment late loss (0.06 ± 0.37 mm versus 0.02 ± 0.46 mm, p noninferiority < 0.0001, and p superiority = 0.24) at 278 ± 63 days after index stent implantation.
Conclusions:
One-year outcome in association with EES and SES was similar with low rate of stent thrombosis and TLR in either arm.
Perspective:
SES, the first DES to be approved for clinical practice, has demonstrated the lowest TLR and angiographic restenosis rates, but is no longer marketed in the United States. The second-generation DES in general, and the EES in particular have demonstrated similarly low TLR rates, and appear to have even lower rates of stent thrombosis (Palmerini, Lancet 2012;379:1393-402). This large study from Japan adds to the data on the remarkable safety and efficacy of the EES.
Keywords: Japan, Sirolimus, Stents
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