Everolimus equivalent to sirolimus stent
MedWire News: Patients given an everolimus-eluting stent (EES) do as well as those given a sirolimus-eluting stent (SES) during the first year after treatment, shows a large randomized trial.
The Randomised Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET) investigators reported outcomes for 3146 patients who had 1 year of clinical follow-up and 8-12 months of angiographic follow-up.
They found that the rates of target-lesion revascularization and in-segment late loss were similar between the two groups.
Presenting the findings at the European Society of Cardiology annual congress in Paris, France, Takeshi Kimura (Kyoto University Hospital, Japan) conceded that the results have somewhat limited clinical relevance, given the impending discontinuation of SESs. However, he speculated that generic SESs may soon become available.
"In those cases, these trial results may be of practical value," he said.
RESET was an "all-comers" trial conducted across 100 Japanese centers. Approximately one-third of potential participants agreed to be randomized to an EES or SES; nine subsequently withdrew consent, and 51 lacked sufficient follow-up, leaving 3146 for analysis.
The rate of target-lesion revascularization was 4.3% in the EES group compared with 5.0% in the SES group, demonstrating statistical non-inferiority of the EES (p<0.001). Similarly, the rate of in-segment late loss was 0.07 mm in the EES versus 0.03 mm in the SES group (p for non-inferiority <0.001).
In pre-specified subgroup analyses, patients who were diabetic, older than 75 years, or required hemodialysis did equally well with both stents. However, diabetics who used insulin were 58% less likely to require target-lesion revascularization if they had an EES rather than a SES (p=0.03), and there was a trend towards improved outcomes among patients with multivessel disease if they received an EES (p=0.07).
Rates of in-stent thrombosis did not differ between the two treatment groups, at 0.39% among patients with an EES versus 0.38% among those with an SES. In-stent late loss was also unaffected by treatment allocation, at 0.16 and 0.14 mm among patients assigned to an EES and SES, respectively.
Kimura commented that the performance of SESs is a "benchmark" for drug-eluting stents, so it will be important to study longer-term follow-up data from the RESET participants regarding late and very late in-stent thrombosis.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
By Eleanor McDermid