Comparison of a novel biodegradable polymer sirolimus-eluting stent With a durable polymer everolimus-eluting stent results of the randomized BIOFLOW-II trial

Windecker, Stephan; Haude, Michael; Neumann, Franz-Josef; Stangl, karl; Witzenbichler, Bernhard; Slagboom, Ton; Sabaté, Manel; Goicolea, Javier; Barragan, Paul; Cook, Stéphane; Piot, Christophe; Richardt, Gert; Merkely, Béla; Schneider, Henrik; Bilger, Johannes; Erne, Paul; Waksman, Ron; Zaugg, Serge; Jüni, Peter; Lefèvre, Thierry

doi:10.1161/CIRCINTERVENTIONS.114.001441

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Journal article

Comparison of a novel biodegradable polymer sirolimus-eluting stent With a durable polymer everolimus-eluting stent results of the randomized BIOFLOW-II trial

Windecker, Stephan Department of Cardiology, Bern University Hospital, Bern, Switzerland
Haude, Michael Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany
Neumann, Franz-Josef Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany
Stangl, karl Charité-Campus Mitte, Berlin, Germany
Witzenbichler, Bernhard Charité Campus Benjamin Franklin, Berlin, Germany
Slagboom, Ton Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
Sabaté, Manel Hospital Clínic, Thorax Institute, Barcelona, Spain - IDIBAPS, University of Barcelona, Barcelona, Spain
Goicolea, Javier Hospital Puerta de Hierro, Madrid, Spain
Barragan, Paul Polyclinique les Fleurs, Ollioules, France
Cook, Stéphane Hospital and University of Fribourg, Switzerland
Piot, Christophe University of Montpellier, Montpellier, France
Richardt, Gert Segeberger Kliniken, Bad Segeberg, Germany
Merkely, Béla Semmelweis University Heart and Vascular Center, Budapest, Hungary
Schneider, Henrik Universitätsklinikum Rostock, Rostock, Germany
Bilger, Johannes Klinikum Nürnberg Süd, Nürnberg, Germany
Erne, Paul Lucerne Canton Hospital, Lucerne, Switzerland
Waksman, Ron MedStar Health Research Institute, Washington, DC
Zaugg, Serge Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
Jüni, Peter Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
Lefèvre, Thierry ICPS, Massy, France

02.01.2015

Published in:

Circulation: Cardiovascular Interventions. - 2015, vol. 8, no. 2, p. e001441

English Background—Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months.Methods and Results—A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, −0.06 to 0.07; P_{noninferiority}<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40–1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10±0.04 mm versus 0.11±0.04 mm; −0.01 [−0.04, −0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16±0.33 mm² versus X-EES, 0.43±0.56 mm²; P=0.04).Conclusions—Compared with durable polymer X-EES, novel biodegradable polymer–based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.

Faculty

Faculté des sciences et de médecine

Department

Médecine 3ème année

Language