Randomized comparison of sirolimus eluting, and biolimus eluting bioresorbable polymer stents: the SORT-OUT VII optical coherence tomography study. (28th March 2017)

• Record Type: Journal Article
• Authors: Andreasen, Lene N; Holm, Niels R; Balleby, Ida R; Krusell, Lars R; Maeng, Michael; Jakobsen, Lars; Veien, Karsten T; Hansen, Knud N; Kristensen, Steen D; Hjort, Jakob; Kaltoft, Anne; Dijkstra, Jouke; Terkelsen, Christian J; Lassen, Jens F; Madsen, Morten; Bøtker, Hans Erik; Jensen, Lisette O; Christiansen, Evald H
• Is Part Of: European heart journal. Volume 19:Number 3(2018)
• Page Start: 329
• Page End: 338
• Publication Date: 2017-03-28
• Subjects: drug-eluting stents -- bioresorbable polymer stents -- optical coherence tomography; Cardiovascular system -- Imaging -- Periodicals; Heart -- Imaging -- Periodicals; 616.10754
• DOI: 10.1093/ehjci/jex035
• Languages: English
• ISSNs: 2047-2404

Abstract

Abstract: Aims: To show non-inferiority of the 67- or 87 µm thick, sirolimus-eluting Orsiro drug eluting stent (DES) to the 122 µm thick, biolimus-eluting Nobori DES regarding size of vessel lumen outside the stent at 13-month follow-up. Methods and results: This study was a substudy to the SORT-OUT VII trial, a prospective, 1:1-randomized, comparison of the two stents in patients with stable coronary artery disease or acute coronary syndrome. Optical coherence tomography was acquired after percutaneous coronary intervention and at 13-month follow-up. The substudy was powered to access non-inferiority (Δ = 0.60 mm 2 ) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro ( n = 60) or Nobori ( n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.26 mm 2, but increased to 0.82 mm 2 after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-inferiority limit. Testing for superiority, Orsiro had a significantly larger mean ESL at follow-up (Orsiro: 0.11 mm 2 [0.02;0.30] mm 2, Nobori: 0.03 mm 2 [0.00;0.17] mm 2, P = 0.04). Stent strut coverage was, Orsiro: 97.6 % [93.8;99.4]%, and Nobori: 96.3 % [90.5;98, 6]% ( P = 0.13). Conclusion: Orsiro DES had a significantly larger mean ESL at follow-up and it could not be excluded that Orsiro exceeded the limit for non-inferiority. Nobori DES had a more heterogeneous distribution of neointima but stent strut coverage did not differ significantly between the two stents.