Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated with Percutaneous Coronary Intervention: From the SORT OUT VII Trial

Kirstine Nørregaard Hansen*, Lisette Okkels Jensen, Michael Maeng, Martin Kirk Christensen, Manijeh Noori, Johnny Kahlert, Lars Jakobsen, Anders Junker, Phillip Freeman, Julia Ellert-Gregersen, Bent Raungaard, Christian Juhl Terkelsen, Karsten Tange Veien, Evald Høj Christiansen

*Kontaktforfatter

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstract

Background: Biodegradable polymer drug-eluting stents were developed to improve safety and efficacy outcomes for patients undergoing percutaneous coronary intervention. However, few long-term follow-up efficacy studies are available. The study sought to investigate 5-year results from the SORT OUT VII trial (Scandinavian Organization for Randomized Trials With Clinical Outcome) comparing the biodegradable polymer ultrathin-strut sirolimus-eluting Orsiro stent (O-SES) versus the biodegradable polymer biolimus-eluting Nobori stent (N-BES). Methods: This registry-based, randomized, multicenter, single-blinded, noninferiority trial compared O-SES and N-BES in an all-comer population. The composite primary end point, target lesion failure, consisted of cardiac death, myocardial infarction related to the target lesion, or target lesion revascularization within 1 year. Follow-up was extended to 5 years. Results: Five-year follow-up was completed for 2521 patients (99.8%). Five-year target lesion failure did not differ between O-SES (12.4%) and N-BES (13.1%; rate ratio [RR], 0.94 [95% CI, 0.75-1.18]). Cardiac death (RR, 0.95 [95% CI, 0.67-1.34]), target myocardial infarction (RR, 1.14 [95% CI, 0.76-1.71]), target lesion revascularization (RR, 0.90 [95% CI, 0.67-1.21]), and definite stent thrombosis rates (RR, 0.73 [95% CI, 0.41-1.33]) did not differ significantly between the 2 stents. Within the first year, definite ST was significantly lower for O-SES (0.4%) compared to N-BES (1.2%; RR, 0.33 [95% CI, 0.12-0.92]), but no difference was from 1 through 5 years: O-SES 1.2% and N-BES 0.9% (RR, 1.28 [95% CI, 0.58-2.82]). Conclusions: Five years after treatment with biodegradable polymer stents, target lesion failure did not differ among O-SES and N-BES. Definite stent thrombosis was less often seen within the first year in the O-SES but the difference was not maintained after 5 years. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT01879358.

OriginalsprogEngelsk
ArtikelnummerE012332
TidsskriftCirculation: Cardiovascular Interventions
Vol/bind16
Udgave nummer1
ISSN1941-7640
DOI
StatusUdgivet - 1. jan. 2023

Bibliografisk note

Funding Information:
This study was an investigator-initiated study and supported with an equal unrestricted grant from Biotronik, Bülach, Switzerland, and Terumo, Tokoyo, Japan. These companies did not have a role in study design, data collection, data analysis, or interpretation of results. They also did not have access to the clinical trial database or an opportunity to review the article.

Fingeraftryk

Dyk ned i forskningsemnerne om 'Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated with Percutaneous Coronary Intervention: From the SORT OUT VII Trial'. Sammen danner de et unikt fingeraftryk.

Citationsformater