Everolimus-eluting SYNERGY Stent Versus Biolimus-eluting Biomatrix NeoFlex Stent - SORT-OUT VIII (SORT-OUT VIII)

Randomized Clinical Comparison of Everolimus-Eluting SYNERGY® and Biolimus-Eluting BioMatrix NeoFlex® Coronary Stents in Non-Selected Patients With Ischemic Heart Disease

The purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Intervention / Treatment: Device: SYNERGY stent; Device: Biomatrix NeoFlex coronary stent

Detailed Description

SORT-OUT VIII is a randomised, multicenter, all-comer, two-arm, non-inferiority trial comparing the everolimus-eluting SYNERGY stent versus the Biomatrix NeoFlex stent in treatment of atherosclerotic coronary artery lesions.

Primary Endpoint:

Device-related Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related acute myocardial infarction (AMI) not clearly related to another lesion than the target lesion, or target lesion revascularisation (TLR) (new revascularization of target lesion) (significant stenosis in the stent ± 5 mm distal/proximal) by percutaneous coronary intervention (PCI) or coronary artery bypass operation (CABG) within 12 months.

Secondary Endpoint:

Device-related target lesion failure hierarchically as cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than the target lesion, or new target lesion revascularization by percutaneous coronary intervention or coronary bypass operation at 2-5 years.

Patient-related combined endpoint hierarchically as all-cause death, non-index procedure related acute myocardial infarction or all new revascularizations by percutaneous coronary intervention or coronary bypass operation at 12, 24, 36, 48 and 60 months.

Individual above mentioned stent- or patient-related endpoints at 12, 24, 36, 48 and 60 months

MACE (combined endpoint as cardiac death, acute myocardial infarction or new revascularization of the study vessel)

Stent thrombosis defined according to the Academic Research Consortium (ARC) criteria within 24 hours (acute), between 1 and 30 days (subacute), between 30 days and 12 months (late), and after 12, 24, 36, 48 and 60 months (very late).

Device success rate defined as the frequency of a successful implantation with residual stenosis < 20% of the study stent in all the stenoses scheduled to be treated.

Procedural success rate defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated and without serious complications (cardiac death, non-index procedure related acute myocardial infarction related to target vessel or new revascularization of target lesion by percutaneous coronary intervention or coronary bypass operation).

Inclusion criteria:

All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.

Exclusion criteria Age < 18 years The patient does not wish to participate The patient is not able to consent to randomization (eg intubated patients) The patient do not live in Western Denmark The patient do not speak Danish The patient is already included in this study The patient is participating in other stent studies Life expectancy <1 year Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor Allergic to everolimus or biolimus Only implanted bare metal stents (BMS) Only performed plain old balloon angioplasty (POBA)

• Study Type: Interventional
• Enrollment (Actual): 2800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aarhus University Hospital Aalborg
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Aarhus N
    • Skejby, Aarhus N, Denmark, 8200
      • Aarhus 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:

• All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.

Exclusion Criteria:

• Age < 18 years
• The patient does not wish to participate
• The patient is not able to consent to randomization (eg intubated patients)
• The patient do not live in West Denmark
• The patient do not speak Danish
• The patient is already included in this study
• The patient is already participating in other stent studies
• Life expectancy <1 year
• Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor
• Allergic to everolimus or biolimus
• Only implanted BMS
• Only performed POBA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SYNERGY; Coronary implantatation of the SYNERGY everolimus-eluting stent	Device: SYNERGY stent; Percutaneous coronary intervention involving use of stent; Other Names: Everolimus-eluting SYNERGY coronary stent
Active Comparator: Biomatrix Neoflex; Coronary implantation of the biolimus-eluting Biomatrix NeoFlex stent	Device: Biomatrix NeoFlex coronary stent; Percutaneous coronary intervention involving use of stent; Other Names: Biolimus-eluting Biomatrix NeoFlex coronary stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related target lesion failure	Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation (significant stenosis in the stent =/+ 5 mm distal/proximal) by percutaneous coronary intervention or coronary artery bypass operation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related target lesion failure	Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation by percutaneous coronary intervention or coronary artery bypass operation	2, 3, 4 and 5 years
Patient-related combined endpoint	Hierarchically as all-cause death, non-index procedure related acute myocardial infarction, or all new revascularisation by percutaneous coronary intervention or coronary artery bypass operation	1, 2, 3, 4 and 5 year
Individual above mentioned stent- or patient-related endpoints		1, 2, 3, 4 and 5 years
MACE	Combined endpoint as cardiac death, acute myocardial infarction or new revascularisation of the study vessel	1, 2, 3, 4 and 5 years
Stent thrombosis	Stent thrombosis according to the Academic Research Consortium definitions	Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years
Device success rate	The frequency of a successful implantation with residual stenosis <20% of the study stent in all stenoses scheduled to be treated	intraoperative

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Boston Scientific Corporation; Biosensors Europe SA
• Investigators: Principal Investigator: Michael Maeng, MD, Aarhus University Hospital, Skejby, Aarhus N; Study Chair: Evald H Christiansen, MD, Aarhus University Hospital

Publications and helpful links

General Publications

• Maeng M, Christiansen EH, Raungaard B, Kahlert J, Terkelsen CJ, Kristensen SD, Carstensen S, Aaroe J, Jensen SE, Villadsen AB, Lassen JF, Thim T, Eftekhari A, Veien KT, Hansen KN, Junker A, Botker HE, Jensen LO; SORT OUT VIII Investigators. Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial). JACC Cardiovasc Interv. 2019 Apr 8;12(7):624-633. doi: 10.1016/j.jcin.2018.12.036.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2014
• Primary Completion (Actual): August 24, 2015
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Stent; Percutaneous coronary intervention; Angina pectoris; DES
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 1-10-72-3-14