Journal article
Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Outcomes of the Randomized BIOFLOW-II Trial.
- Lefèvre T Department of Interventional Cardiology, Hopital Jacques Cartier, Massy, France. Electronic address: t.lefevre@angio-icps.com.
- Haude M Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus, Neuss, Germany.
- Neumann FJ Department of Cardiology and Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
- Stangl K Department of Cardiology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.
- Skurk C Department of Cardiology, Charité Campus Benjamin Franklin, Berlin, Germany.
- Slagboom T Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
- Sabaté M Department of Cardiology, Hospital Clínic, Thorax Institute, Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.
- Goicolea J Department of Cardiology, Hospital Puerta de Hierro, Madrid, Spain.
- Barragan P Department of Cardiology, Polyclinique les Fleurs, Ollioules, France.
- Cook S Department of Cardiology, Hospital and University Fribourg, Switzerland.
- Macia JC Department of Cardiology, University of Montpellier, Montpellier, France.
- Windecker S Department of Cardiology, Bern University Hospital, Bern, Switzerland.
- 2018-05-26
Published in:
- JACC. Cardiovascular interventions. - 2018
biodegradable polymer
coronary artery disease
drug-eluting stent(s)
sirolimus
Absorbable Implants
Aged
Cardiovascular Agents
Coronary Artery Disease
Coronary Thrombosis
Drug-Eluting Stents
Europe
Everolimus
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
Polyesters
Prosthesis Design
Risk Factors
Sirolimus
Time Factors
Treatment Outcome
English
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 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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1016/j.jcin.2018.04.014
- PMID 29798778
- Persistent URL
- https://sonar.ch/global/documents/185181
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