Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV

Lisette Okkels Jensen, Per Thayssen, Evald Høj Christiansen, Michael Maeng, Jan Ravkilde, Knud Nørregaard Hansen, Henrik Steen Hansen, Lars Krusell, Anne Kaltoft, Hans Henrik Tilsted, Klara Berencsi, Anders Junker, Jens Flensted Lassen, SORT OUT IV Investigators

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Abstrakt

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).

OriginalsprogEngelsk
TidsskriftAmerican College of Cardiology. Journal
Vol/bind67
Udgave nummer7
Sider (fra-til)751-762
Antal sider12
ISSN0735-1097
DOI
StatusUdgivet - 23. feb. 2016

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  • Citationsformater

    Jensen, L. O., Thayssen, P., Christiansen, E. H., Maeng, M., Ravkilde, J., Hansen, K. N., Hansen, H. S., Krusell, L., Kaltoft, A., Tilsted, H. H., Berencsi, K., Junker, A., Lassen, J. F., & SORT OUT IV Investigators (2016). Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV. American College of Cardiology. Journal, 67(7), 751-762. https://doi.org/10.1016/j.jacc.2015.11.051