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Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents

Abstract Background Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. Objectives This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clini...

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Published in:Journal of the American College of Cardiology 2016-02, Vol.67 (7), p.751-762
Main Authors: Jensen, Lisette Okkels, MD, DMSci, PhD, Thayssen, Per, MD, DMSci, Christiansen, Evald Høj, MD, PhD, Maeng, Michael, MD, PhD, Ravkilde, Jan, MD, DMSci, Hansen, Knud Nørregaard, MD, Hansen, Henrik Steen, MD, DMSci, Krusell, Lars, MD, Kaltoft, Anne, MD, PhD, Tilsted, Hans Henrik, MD, Berencsi, Klara, MSc, Junker, Anders, MD, PhD, Lassen, Jens Flensted, MD, PhD
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Language:English
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Summary:Abstract Background Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. Objectives This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial. Methods Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis. Results At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72). Conclusions At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877 )
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2015.11.051