TY - JOUR
T1 - 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
T2 - The SORT OUT VII Trial
AU - Jensen, L. O.
AU - Thayssen, P.
AU - Maeng, Michael
AU - Ravkilde, Jan
AU - Krusell, Lars Romer
AU - Raungaard, Bent
AU - Junker, A.
AU - Terkelsen, Christian Juhl
AU - Veien, K. T.
AU - Villadsen, Anton Boel
AU - Kaltoft, Anne
AU - Tilsted, Hans-Henrik
AU - Hansen, Knud Nørregaard
AU - Aaroe, Jens
AU - Dalby Kristensen, Steen
AU - Hansen, H. S.
AU - Jensen, Svend Eggert
AU - Madsen, Morten
AU - Bøtker, Hans Erik
AU - Berencsi, Klara
AU - Lassen, Jens Flensted
AU - Christiansen, Evald Høj
N1 - 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
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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.
AB - 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.
KW - chromium drug-eluting stent myocardial infarction percutaneous coronary intervention thrombosis non-inferiority trial durable-polymer artery-disease myocardial-infarction unselected patients superiority trial coated stent everolimus revascularization pacl
KW - chromium
KW - percutaneous coronary intervention
KW - drug-eluting stent
KW - thrombosis
KW - myocardial infarction
U2 - 10.1161/circinterventions.115.003610
DO - 10.1161/circinterventions.115.003610
M3 - Journal article
VL - 9
JO - Circulation. Cardiovascular Interventions
JF - Circulation. Cardiovascular Interventions
SN - 1941-7640
IS - 7
M1 - e003610
ER -