Clinical trial NCT02093845: Everolimus-eluting SYNERGY Stent Versus Biolimus-eluting Biomatrix NeoFlex Stent - SORT-OUT VIII
Official title: Randomized Clinical Comparison of Everolimus-Eluting SYNERGY® and Biolimus-Eluting BioMatrix NeoFlex® Coronary Stents in Non-Selected Patients With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: Percutaneous coronary intervention
DES
Angina pectoris
Stent
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Biosensors Europe SA
First posted: 2014-03-21
Enrollment: 2800
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 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Device-related target lesion failure
timeFrame: 12 months
Secondary outcomes:
measure: Device-related target lesion failure
timeFrame: 2, 3, 4 and 5 years
measure: Patient-related combined endpoint
timeFrame: 1, 2, 3, 4 and 5 year
measure: Individual above mentioned stent- or patient-related endpoints
timeFrame: 1, 2, 3, 4 and 5 years
measure: MACE
timeFrame: 1, 2, 3, 4 and 5 years
measure: Stent thrombosis
timeFrame: Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years
measure: Device success rate
timeFrame: intraoperative
Other outcomes:
Locations:
city: Skejby
country: Denmark
facility: Aarhus University Hospital
state: Aarhus N
city: Aalborg
country: Denmark
facility: Aarhus University Hospital Aalborg
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University Hospital, Skejby, Aarhus N
name: Michael Maeng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Evald H Christiansen, MD
role: STUDY_CHAIR
References:
citation: 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.