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

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• 作者：Lisette Okkels Jensen ; MD ; DMSci ; PhD^a ; ^{okkels@dadlnet.dk" class="auth_mail" title="E-mail the corresponding author} ; Per Thayssen ; MD ; DMSci^a ; Evald Hø ; j Christiansen ; MD ; PhD^b ; Michael Maeng ; MD ; PhD^b ; Jan Ravkilde ; MD ; DMSci^c ; Knud Nø ; rregaard Hansen ; MD^a ; Henrik Steen Hansen ; MD ; DMSci^a ; Lars Krusell ; MD^b ; Anne Kaltoft ; MD ; PhD^b ; Hans Henrik Tilsted ; MD^c ; Klara Berencsi ; MSc^d ; Anders Junker ; MD ; PhD^a ; Jens Flensted Lassen ; MD ; PhD^b ; for the SORT OUT IV Investigators
• 关键词：drug-eluting stent(s) ; outcome ; percutaneous coronary intervention ; very late definite stent thrombosis
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：23 February 2016
• 年：2016
• 卷：67
• 期：7
• 页码：751-762
• 全文大小：814 K

文摘

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)