August 31, 2011
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Everolimus-eluting stent demonstrated noninferiority to sirolimus-eluting stent

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European Society of Cardiology Congress 2011

One-year results indicated that an everolimus-eluting stent was noninferior to a sirolimus-eluting stent regarding target lesion revascularization rate, according to study results.

The aim of the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET) was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in daily clinical practice at 100 centers in Japan.

Eligible patients were scheduled for percutaneous coronary intervention with drug-eluting stents (DES) and were enrolled without any exclusion criteria.

The primary efficacy endpoint of the noninferiority and superiority study was defined as any target lesion revascularization at 1 year after the index procedure. The researchers also conducted an angiographic substudy evaluating in-segment late lumen loss and angiographic restenosis rate at the 8-month mark. The substudy involved 571 patients.

There were 3,206 patients enrolled between February and July 2010; the final analysis included 3,197 patients assigned to EES or SES. EES demonstrated noninferiority to SES regarding target lesion revascularization rate at 1 year and angiographic in-segment late lumen loss at 8 to 12 months.

“One-year clinical outcome after both EES and SES use was excellent … with (a) low rate of target lesion revascularization and very low rate of stent thrombosis,” Takeshi Kimura, MD, of Kyoto University Hospital in Japan, said in a press release.

Kimura noted several limitations, including that SES were not widely used when the trial was conducted, but they were the most widely used and most exhaustively studied DES from the first generation. Clinical outcome after implantation of SES should provide the basis on which DES outcomes are based, according to Kimura.

Because of the relatively low-risk nature of the patients in the study, event rates may have been accordingly low, he said, adding that future studies should involve higher-risk patients.

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Disclosure: Dr. Kimura reports being on the scietific advisory boards and receiving honoraria from Abbott Vascular, Cordis Cardiology and Terumo Company. The RESET trial was sponsored by Abbott Vascular.

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