Author + information
- Received November 4, 2013
- Revision received February 3, 2014
- Accepted February 13, 2014
- Published online August 1, 2014.
- Lisette Okkels Jensen, MD, DMSci, PhD∗∗ (, )
- Per Thayssen, MD, DMSci∗,
- Michael Maeng, MD, PhD†,
- Evald Høj Christiansen, MD, PhD†,
- Jan Ravkilde, MD, DMSci‡,
- Knud Nørregaard Hansen, MD∗,
- Anne Kaltoft, MD, PhD†,
- Hans Henrik Tilsted, MD‡,
- Morten Madsen, MSc§,
- Jens Flensted Lassen, MD, PhD†,
- Scandinavian Organization for Randomized Trials With Clinical Outcome SORT OUT IV Investigators
- ∗Department of Cardiology, Odense University Hospital, Odense, Denmark
- †Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark
- ‡Department of Cardiology, Aalborg University Hospital, Aalborg, Aalborg, Denmark
- §Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
- ↵∗Reprint requests and correspondence:
Dr. Lisette Okkels Jensen, Department of Cardiology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Denmark.
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).
Equal unrestricted grants were received from Abbott Vascular, Boston Scientific, Cordishttp://dx.doi.org/10.13039/100006479, and Johnson & Johnson. These companies did not have a role in study design, data collection, data analysis, or interpretation of results. They also did not have access to the clinical trial database or an opportunity to review the manuscript. Dr. Jensen has received honoraria from Abbott Vascular and Cordis and an unrestricted grant from Terumo to her institution. Dr. Thayssen has received unrestricted grants from Abbott Vascular and Cordishttp://dx.doi.org/10.13039/100006479 to his institution. Dr. Ravkilde has received honoraria from Abbott Vascular and unrestricted grants from Abbott Vascular, Boston Scientific, Cordis Johnson & Johnson, Medtronic, Biosensors, and Terumo to his institution. Dr. Lassen has received unrestricted grants from Abbott Vascular, Boston Scientific, Cordis Johnson & Johnson, Medtronic, Biosensors, Terumo, and St. Jude Medical to his institution. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 4, 2013.
- Revision received February 3, 2014.
- Accepted February 13, 2014.
- American College of Cardiology Foundation