Author + information
- Received December 29, 2017
- Revision received March 12, 2018
- Accepted April 10, 2018
- Published online May 21, 2018.
- Thierry Lefèvre, MDa,∗ (, )
- Michael Haude, MDb,
- Franz-Josef Neumann, MDc,
- Karl Stangl, MDd,
- Carsten Skurk, MDe,
- Ton Slagboom, MDf,
- Manel Sabaté, MDg,
- Javier Goicolea, MDh,
- Paul Barragan, MDi,
- Stéphane Cook, MDj,
- Jean-Christophe Macia, MDk and
- Stephan Windecker, MDl
- aDepartment of Interventional Cardiology, Hopital Jacques Cartier, Massy, France
- bMedical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus, Neuss, Germany
- cDepartment of Cardiology and Angiology, Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany
- dDepartment of Cardiology, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Berlin, Germany
- eDepartment of Cardiology, Charité Campus Benjamin Franklin, Berlin, Germany
- fDepartment of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
- gDepartment of Cardiology, Hospital Clínic, Thorax Institute, Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain
- hDepartment of Cardiology, Hospital Puerta de Hierro, Madrid, Spain
- iDepartment of Cardiology, Polyclinique les Fleurs, Ollioules, France
- jDepartment of Cardiology, Hospital and University Fribourg, Switzerland
- kDepartment of Cardiology, University of Montpellier, Montpellier, France
- lDepartment of Cardiology, Bern University Hospital, Bern, Switzerland
- ↵∗Address for correspondence:
Dr. Thierry Lefèvre, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, 6 avenue du Noyer Lambert, 91300 Massy, France.
Objectives The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimus (O-SES) (Orsiro, BIOTRONIK, Bülach, Switzerland) with the durable polymer-based Xience Prime everolimus-eluting stent (X-EES) (Abbott Vascular, Santa Clara, California).
Background Biodegradable polymer stents have been developed aiming to overcome long-term detrimental effects of durable polymer stents, ultimately leaving a bare-metal stent in the vessel.
Methods This multicenter, assessor-blinded trial randomized 452 patients with 505 lesions to either O-SES or X-EES in a 2:1 fashion. Endpoints at 5 years were target lesion failure (TLF), its components, and stent thrombosis.
Results TLF occurred in 10.4% (n = 30) of O-SES patients versus 12.7% (n = 19) of X-EES patients (p = 0.473), overall stent thrombosis occurred in 0.7% (n = 2) versus 2.8% (n = 4) (p = 0.088), and definite stent thrombosis in 0% versus 0.7% (n = 1) (p = 0.341). Post hoc analysis was performed in diabetic patients (n = 128) and vessels ≤2.75 mm (n = 259). In diabetic patients, the O-SES group had numerically more target lesion revascularizations (13.5% vs. 4.5%; p = 0.138), but fewer cardiac deaths (1.3% vs. 6.9%; p = 0.089) and stent thrombosis (0% vs. 6.9%; p = 0.039). In small vessels, the O-SES group had a significantly lower 5-year mortality (3.7% vs. 11.3%; p = 0.022).
Conclusions At 5 years, the biodegradable polymer O-SES demonstrated low TLF rates comparable to the durable polymer X-EES, confirming its long-term safety and performance. Particularly encouraging is the absence of definite stent thrombosis.
The study was funded by BIOTRONIK AG, Buelach, Switzerland. Dr. Lefèvre has been a proctor for Edwards Lifesciences, Abbott Vascular, and Terumo. Dr. Haude has received study grants and lecture fees from Biotronik, Abbott Vascular, Cardiac Dimensions, Medtronic, Volcano, and Daiichi Sankyo; and has served on an advisory board and speakers bureau for Biotronik. Dr. Neumann has received research support from Biotronik. Dr. Stangl has been a consultant for Abbott Vascular. Dr. Slagboom has been a consultant to Biotronik. Dr. Sabaté has been a consultant for Abbott Vascular. Dr. Windecker has received research grants to the institution from Abbott, Biotronik, Boston Scientific, Biosensors, Medtronic, Edwards Lifesciences, and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 29, 2017.
- Revision received March 12, 2018.
- Accepted April 10, 2018.
- 2018 The Authors
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