Author + information
- Received August 18, 2016
- Revision received October 17, 2016
- Accepted November 3, 2016
- Published online February 6, 2017.
- Bent Raungaard, MD, PhDa,∗ (, )
- Evald H. Christiansen, MD, PhDb,
- Hans Erik Bøtker, MD, DMScib,
- Henrik S. Hansen, MD, DMScic,
- Jan Ravkilde, MD, DMScia,
- Leif Thuesen, MD, DMScia,
- Jens Aarøe, MDa,
- Anton B. Villadsen, MDa,
- Christian J. Terkelsen, MD, DMSci, PhDb,
- Lars R. Krusell, MDb,
- Michael Maeng, MD, PhDb,
- Steen D. Kristensen, MD, DMScib,
- Karsten T. Veien, MDc,
- Knud N. Hansen, MDc,
- Anders Junker, MDc,
- Morten Madsen, MScd,
- Søren L. Andersen, MSc, PhDd,
- Svend E. Jensen, MD, PhDa,
- Lisette O. Jensen, MD, DMSci, PhDc,
- SORT OUT VI Investigators
- aDepartment of Cardiology, Aalborg University Hospital, Aalborg, Denmark
- bDepartment of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark
- cDepartment of Cardiology, Odense University Hospital, Odense, Denmark
- dDepartment of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
- ↵∗Address for correspondence:
Dr. Bent Raungaard, Department of Cardiology, Aalborg University Hospital, Hobrovej 18-22, DK-9000, Aalborg, Denmark.
Objectives The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients.
Background Biodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking.
Methods The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months.
Results From March 2011 to August 2012, 2,999 patients were randomly assigned (1:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33).
Conclusions At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis.
The trial was supported by unrestricted grants from Biosensors Interventional Technologies Pte Ltd. and Medtronic CardioVascular Inc. Dr. Christiansen has received unrestricted research grants to his institution from Biosensors and Medtronic. Dr. Maeng has received research grants from Boston Scientific, Biosensors Interventional Technologies, and Volcano Corporation. Dr. L.O. Jensen has received unrestricted research grants to her institution from Terumo, Biotronik, St. Jude Medical, and Biosensors Interventional Technologies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 18, 2016.
- Revision received October 17, 2016.
- Accepted November 3, 2016.
- American College of Cardiology Foundation