Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial

L. O. Jensen, P. Thayssen, Michael Maeng, Jan Ravkilde, Lars Romer Krusell, Bent Raungaard, A. Junker, Christian Juhl Terkelsen, K. T. Veien, Anton Boel Villadsen, Anne Kaltoft, Hans-Henrik Tilsted, Knud Nørregaard Hansen, Jens Aaroe, Steen Dalby Kristensen, H. S. Hansen, Svend Eggert Jensen, Morten Madsen, Hans Erik Bøtker, Klara BerencsiJens Flensted Lassen, Evald Høj Christiansen

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Abstrakt

Background - Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. Methods and Results - The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial - a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial - compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05). Conclusions - The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year.

OriginalsprogEngelsk
Artikelnummere003610
TidsskriftCirculation. Cardiovascular Interventions
Vol/bind9
Udgave nummer7
Antal sider12
ISSN1941-7640
DOI
StatusUdgivet - 1. jul. 2016

Bibliografisk note

ISI Document Delivery No.: DS2MW Times Cited: 4 Cited Reference Count: 34 Jensen, Lisette Okkels Thayssen, Per Maeng, Michael Ravkilde, Jan Krusell, Lars Romer Raungaard, Bent Junker, Anders Terkelsen, Christian Juhl Veien, Karsten Tange Villadsen, Anton Boel Kaltoft, Anne Tilsted, Hans-Henrik Hansen, Knud Norregaard Aaroe, Jens Kristensen, Steen Dalby Hansen, Henrik Steen Jensen, Svend Eggert Madsen, Morten Botker, Hans Erik Berencsi, Klara Lassen, Jens Flensted Christiansen, Evald Hoj Biotronik, Bulach, Switzerland; Terumo, Tokyo, Japan This study was an investigator initiated study and supported with an equal unrestricted grants from Biotronik, Bulach, Switzerland, and Terumo, Tokyo, 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. The corresponding author had full access to all the data in the study and final responsibility to submit for publication. 4 2 Lippincott williams & wilkins Philadelphia 1941-7632

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