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
2015-01-02
<strong>Background—</strong>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.<strong>Methods and Results—</strong>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; <em>P</em><sub>noninferiority</sub><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: <em>P</em>=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]; <em>P</em>=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; <em>P</em>=0.04).<strong>Conclusions—</strong>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.<strong>Clinical Trial Registration—</strong>URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.
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https://folia.unifr.ch/global/documents/304427
https://folia.unifr.ch/documents/304427/files/coo_cnb.pdf
eng
info:eu-repo/semantics/altIdentifier/doi/10.1161/CIRCINTERVENTIONS.114.001441
info:eu-repo/semantics/openAccess
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Circulation: Cardiovascular Interventions. - 2015, vol. 8, no. 2, p. e001441
info:eu-repo/classification/udc/616
Comparison of a novel biodegradable polymer sirolimus-eluting stent With a durable polymer everolimus-eluting stent results of the randomized BIOFLOW-II trial
http://purl.org/coar/resource_type/c_6501