Thierry Lefèvre1, Michael Haude2, Franz-Josef Neumann3, Karl Stangl4, Carsten Skurk5, Ton Slagboom6, Manel Sabaté7, Javier Goicolea8, Paul Barragan9, Stéphane Cook10, Jean-Christophe Macia11, Stephan Windecker12. 1. Department of Interventional Cardiology, Hopital Jacques Cartier, Massy, France. Electronic address: t.lefevre@angio-icps.com. 2. Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus, Neuss, Germany. 3. Department of Cardiology and Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. 4. Department of Cardiology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany. 5. Department of Cardiology, Charité Campus Benjamin Franklin, Berlin, Germany. 6. Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 7. Department of Cardiology, Hospital Clínic, Thorax Institute, Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain. 8. Department of Cardiology, Hospital Puerta de Hierro, Madrid, Spain. 9. Department of Cardiology, Polyclinique les Fleurs, Ollioules, France. 10. Department of Cardiology, Hospital and University Fribourg, Switzerland. 11. Department of Cardiology, University of Montpellier, Montpellier, France. 12. Department of Cardiology, Bern University Hospital, Bern, Switzerland.
Abstract
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.
RCT Entities:
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-SESpatients 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 diabeticpatients (n = 128) and vessels ≤2.75 mm (n = 259). In diabeticpatients, 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.
Authors: Rosaly A Buiten; Eline H Ploumen; Paolo Zocca; Carine J M Doggen; Liefke C van der Heijden; Marlies M Kok; Peter W Danse; Carl E Schotborgh; Martijn Scholte; Frits H A F de Man; Gerard C M Linssen; Clemens von Birgelen Journal: JAMA Cardiol Date: 2019-07-01 Impact factor: 14.676
Authors: Mahesh V Madhavan; James P Howard; Azim Naqvi; Ori Ben-Yehuda; Bjorn Redfors; Megha Prasad; Bahira Shahim; Martin B Leon; Sripal Bangalore; Gregg W Stone; Yousif Ahmad Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983