BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX (SORT OUT IX)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ischaemic Heart Disease
• Intervention / Treatment: Device: Biofreedom; Device: Orsiro

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofreedom; Biofreedom stent treatment at index procedure	Device: Biofreedom; PCI with Biofreedom stent
Active Comparator: Orsiro; Orsiro stent treatment at index procedure	Device: Orsiro; PCI with Orsiro stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure	Primary endpoint assessed after 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure	Target lesion failure will be assessed yearly up to 5 years after index procedure	2 year, 3 year, 4 year, 5 year
Stent thrombosis	Stent thrombosis will be assessed yearly up to 5 years after index procedure	1 year, 2 years, 3 years, 4 years, 5 years
Myocardial infarction	Myocardial infarction will be assessed yearly up to 5 years after index procedure	1 year, 2 years, 3 years, 4 years, 5 years
Cardiac death	Cardiac death will be assessed yearly up to 5 years after index procedure	1 year, 2 years, 3 years, 4 years, 5 years
All cause mortality	All cause mortality will be assessed yearly up to 5 years after index procedure	1 year, 2 years, 3 years, 4 years, 5 years
Target lesion revascularization	Target lesion revascularization will be assessed yearly up to 5 years after index procedure	1 year, 2 years, 3 years, 4 years, 5 years
Target vessel revascularization	Target vessel revascularization will be assessed yearly up to 5 years after	1 year, 2 years, 3 years, 4 years, 5 years

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Aarhus University Hospital Skejby; Rigshospitalet, Denmark; Aalborg University Hospital
• Investigators: Study Chair: Lisette Okkels Jensen, MD DMSci PhD, Odense University Hospital; Study Chair: Evald H Christiansen, MD PhD, Aarhus University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Outcomes; Coronary drug eluting stents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: SORT OUT IX