Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent. (February 2015)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Circulation. Volume 8:Number 2(2015)
• Publication Date: 2015-02
• Subjects: Cardiovascular system -- Surgery -- Periodicals; Cardiovascular system -- Diseases -- Treatment -- Periodicals; 616.105
• DOI: 10.1161/CIRCINTERVENTIONS.114.001441
• Languages: English
• ISSNs: 1941-7640

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Background—</title> <p>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.</p> </sec> <sec> <title>Methods and Results—</title> <p>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; <italic>P</italic><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: <italic>P</italic>=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]; <italic>P</italic>=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 mm<sup>2</sup> versus X-EES, 0.43±0.56 mm<sup>2</sup>; <italic>P</italic>=0.04).</p> </sec> <sec> <title>Conclusions—</title> <p>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.</p> </sec> <sec> <title>Clinical Trial Registration—</title> <p>URL: <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">http://www.clinicaltrials.gov</ext-link>. Unique identifier: NCT01356888.</p> </sec> </abstract>