1 The Faculty of Medicine, Aalborg University, VBN2 Klinik Hjerte-Lunge, The Faculty of Medicine, Aalborg University, VBN3 Hjertemedicin (Kardiologi), The Faculty of Medicine, Aalborg University, VBN4 Aalborg University Hospital, The Faculty of Medicine, Aalborg University, VBN5 Department of Cardiology, Odense University Hospital.6 Department of Cardiology B, Odense University Hospital, Odense, Denmark.7 Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.8 Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.9 unknown
OBJECTIVES: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. BACKGROUND: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES. METHODS: We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis). RESULTS: At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70). CONCLUSIONS: At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).
J a C C: Cardiovascular Interventions, 2014, Vol 7, Issue 8, p. 840-848