Original title: Everolimus-eluting stents in patients undergoing percutaneous coronary Intervention: Final 3-year results of the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions trial. Reference: Sorin J. Brener et al. Am Heart J 2013;0:1-8.
The XIENCE stent (Abbott Vascular, Santa Clara, CA) is an eluting 2nd generation stent, consisting of the Multilink Vision cobalt–chromium (Co–Cr) platform with a nonerodable biocompatible polymer and 100 g/cm2 everolimus, a synthetic derivative of sirolimus (40-O-[2-hydroxyethyl]-rapamycin). The 6–8-µm thick polymer is composed of acrylic and fluorinated polymers and releases 80% of the drug within 30 days, with nearly all the drug released within 4 months.
The largest randomized study to date evaluating this stent was the SPIRIT IV and this is the final report with the follow-up to 3 years. The SPIRIT IV included 3687 patients with up to 3 lesions in 1 to 2 epicardial coronary arteries randomized 2:1 to everolimus-eluting stent or paclitaxel-eluting stent. The primary end point was the target lesion failure (a combined safety and efficacy that included cardiac death, infarct related to the vessel and guided revascularization myocardial ischemia injury). One third of patients were diabetic and about 30 % were admitted to the study for unstable angina. Baseline characteristics of the population were well balanced. At 3 years, the primary end point occurred in 9.2% of patients receiving the everolimus eluting stent versus 11.7% of those who received the paclitaxel-eluting stent (HR 0.78, 0.63 to 0.97, p = 0 , 02) . The absolute risk reduction at 3 years was 2.5 % with a number needed to treat of 40 patients. The composite of death and myocardial infarction was 5.9 % versus 9.1 %, respectively (p = 0.001), observed a 33% reduction in the incidence of stroke related to vessel with everolimus-eluting stent. The largest difference was observed with 64% reduction in stent thrombosis (definite or feasible) with XIENCE.
Unlike the above, guided revascularization myocardial ischemia injury to 3 years did not reach statistical significance with 6.2 % versus 7.8% (p = 0.06) respectively. In the subgroup of diabetic patients, no effect difference was observed with XIENCE among those who required insulin and those who not.
Conclusion:
The everolimus-eluting stent was associated with a significantly lower rate of cardiac death, MI and stent thrombosis at 3 years that the paclitaxel-eluting stent.
Editorial comment
The advantage of the everolimus-eluting stent was based on a better safety profile than greater efficiency.
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