Clinical trial NCT02623140: BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX
Official title: Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischaemic Heart Disease
Keywords: Coronary drug eluting stents
Outcomes
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
name: Aalborg University Hospital
name: Rigshospitalet, Denmark
First posted: 2015-12-07
Enrollment: 3150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events

Detailed description: SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions.

Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent (Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web based Trial Partner randomization system will be used.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.

Exclusion Criteria:

* Life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 12 months
Secondary outcomes:
measure: Target lesion failure
timeFrame: 2 year, 3 year, 4 year, 5 year
measure: Stent thrombosis
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Myocardial infarction
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Cardiac death
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: All cause mortality
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Target lesion revascularization
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Target vessel revascularization
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Lisette Okkels Jensen, MD DMSci PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Evald H Christiansen, MD PhD
role: STUDY_CHAIR
References:
citation: Jensen Lisette Okkels, Maeng M, Raungaard B, Kahlert J, Ellert J, Jakobsen L, Villadsen AB, Veien KT, Kristensen SD, Ahlehoff O, Carstensen S, Christensen MK, Terkelsen CJ, Engstroem T, Hansen KN, Botker HE, Aaroe J, Thim T, Thuesen L, Freeman P, Aziz A, Eftekhari A, Junker A, Jensen SE, Lassen JF, Hansen HS, Christiansen EH; Sort Out IX Study Group. Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial. Circulation. 2020 Jun 23;141(25):2052-2063. doi: 10.1161/CIRCULATIONAHA.119.040241. Epub 2020 May 21.
citation: Jensen LO, Maeng M, Raungaard B, Engstrom T, Hansen HS, Jensen SE, Botker HE, Kahlert J, Lassen JF, Christiansen EH. Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial. Am Heart J. 2019 Jul;213:1-7. doi: 10.1016/j.ahj.2019.02.017. Epub 2019 Mar 14.