P C R euro Randomized comparison of a sirolimus-eluting stent with a biolimus-eluting stent in patients treated with PCI: the SORT OUT VII trial Lisette Okkels Jensen, Per Thayssen, Michael Maeng, Jan Ravkilde, Lars Krusell, Hans-Henrik Tilsted, Anders Junker, Christian Juhl Terkelsen, Karsten Tange Veien, Anne Kaltoft, Anton Boel Villadsen, Jens Aaroe, Klára Berencsi, Svend Eggert Jensen, Knud Nørregaard Hansen, Steen Dalby Kristensen, Morten Madsen, Hans Erik Bøtker Henrik Steen Hansen, Bent Raungaard, Jens Flensted Lassen, Evald Høj Christiansen Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital - DENMARK
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P C R euro
Randomized comparison of a sirolimus-eluting stent with a biolimus-eluting stent in patients treated with PCI: the SORT OUT VII trial
Lisette Okkels Jensen, Per Thayssen, Michael Maeng, Jan Ravkilde, Lars Krusell,
Hans-Henrik Tilsted, Anders Junker, Christian Juhl Terkelsen, Karsten Tange Veien,
Anne Kaltoft, Anton Boel Villadsen, Jens Aaroe, Klára Berencsi, Svend Eggert Jensen,
Knud Nørregaard Hansen, Steen Dalby Kristensen, Morten Madsen, Hans Erik Bøtker
Henrik Steen Hansen, Bent Raungaard, Jens Flensted Lassen, Evald Høj Christiansen
Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital - DENMARK
Potential conflicts of interest
SORT OUT VII 1Y
Speaker's name: Lisette Okkels Jensen
I have the following potential conflicts of interest to report:
Honorarium:
ABBOTT VASCULAR, ASTRAZENECA, BIOTRONIK, ST. JUDE MEDICAL
Institutional grant/research support:
BIOSENSORS INTERNATIONAL, BIOTRONIK, ST. JUDE MEDICAL, TERUMO
P C R euro
2015
Background
Drug-eluting stents have reduced the risk of in-stent restenosis.
Compared to first generation drug-eluting stents the second
generation with thinner stent struts have improved safety and
efficacy
Persistence of polymer material on first and second generation
drug-eluting stent after completion of drug release has been
suggested to be a trigger of a chronic inflammatory response
Third generation coronary drug-eluting stents with biodegradable
polymers have been designed to improve safety and efficacy
New ultra-thin strut third generation stents have been developed
and may further improve safety and efficacy
SORT OUT VII 1Y
Primary Endpoint
Objective:
To compare the efficacy and safety of the thin strut, cobalt-chromium
biodegradable polymer sirolimus-eluting Orsiro stent and the stainless
steel biodegradable polymer biolimus-eluting Nobori stent in an all-comer
population
Primary Endpoint:
Target lesion failure: a composite of cardiac death, myocardial infarction
(not related to other than index lesion) or target lesion revascularization
within 1 year
An event rate of 6.5% was assumed in each group. Sample size of 1.157
patients in each treatment arm, a one-sided 0.050 significance level and
a 90% power to detect non-inferiority. Non-inferiority margin of 3.0%
Clinically driven event detection based on Danish registries
SORT OUT VII 1Y
Patient Population Inclusion period: November 2012 to February 2014
Criteria of inclusion
18 years of age or older
Chronic stable coronary artery disease or acute coronary syndromes
Criteria of exclusion
Life expectancy less than one year
Allergy to aspirin, clopidogrel, ticagrelor, sirolimus, or biolimus
Participation in another randomized trial
Unacceptable risk by 12-month dual antiplatelet treatment
Unable to provide written informed consent
No restrictions were placed on number of treated lesions, treated
vessels or lesion length
SORT OUT VII 1Y
Patient Characteristics SIROLIMUS-ELUTING
ORSIRO STENT
BIOLIMUS-ELUTING
NOBORI STENT p
No. of patients 1261 1264
Age (years) 66.1 ± 10.7 64.8 ± 10.8 <0.01
Male gender 74.9 % 75.2 % 0.84
Diabetes 18.7 % 18.6 % 0.94
Hypertension 58.1 % 56.4 % 0.39
Current smoker 29.1 % 32.5 % 0.07
Prior CABG 8.0 % 7.6 % 0.72
Prior PCI 19.0 % 20.4 % 0.39
Prior myocardial infarction 17.4 % 17.8 % 0.83
Body mass Index (kg/m2) 27.5 ± 4.7 27.4 ± 4.4 0.63