Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent (COMPARE-II)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
the everolimus eluting ® stent
the Biolimus A9 eluting NOBORI® stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- The patient is at least 18 years old and has a life expectancy of 5 years.
- Patient undergoes a PCI procedure for indications according to the Dutch and European guidelines
- Patient is willing to comply with the extended follow-up period of 2 to 5 years(for secondary endpoint only)
- Reference lumen diameter of the treated vessels between 2.0 - 4.0 mm.
- Informed consent
Exclusion Criteria:
- Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
- Expected major surgery within 30 days (these patients will receive bare metal stents)
- Cardiogenic shock (Kilip class 4)
- Previous PCI procedures with implantation of drug eluting stents within 1 year.
- Expected loss for follow up
- Enrollment in an investigative stent study with different stents
- Inability to implant Nobori or Xience-V / Promus stent(s)
Sites / Locations
- Onassis cardiac Surgery Centre
- Onze Lieve Vrouwe Gasthuis
- Amphia Ziekenhuis
- Medisch Centrum Leeuwarden
- Maasstad Hospital
- Hospital del Mar
- Complejo Hospitalario Universitario Juan Canalejo
- Hospital Universitario Virgen Arrixaca
- Hospital Clinico universitario de Santiago de Compostella
- Kantonsspital Aarau
- Hopital Cantonal de Fribourg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
the everolimus eluting ® stent
Biolimus A9 stent
Arm Description
the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent
the Biolimus A9 eluting NOBORI® stent
Outcomes
Primary Outcome Measures
Major adverse coronary events
composite of cardiac death, non fatal myocardial infarction and target vessel revascularization
Secondary Outcome Measures
Major adverse coronary events
The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 12 months follow-up.
Safety of stenting with drug eluting stents
Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years
Target lesion revascularization
Target lesion revascularization at 12 months, 3 and 5 years
Late major adverse coronary events
The combined endpoint of cardiac death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 3 and 5 years follow-up.
Major adverse coronary events in subgroups
The combined endpoint of cardiac death, non fatal myocardial infarction and target vessel revascularization at 12 months, 3 and 5 years in STEMI patients, small vessels (< 2.75 mm RVD), long lesions (> 20 mm), female patients, DM patients and octogenarians
Procedural performance
Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.
Stent Thrombosis
Incidence of definite and probable stent thrombosis at 12 months, 3 and 5 years time.
Incidence of definite, probable or possible stent thrombosis at 12 months, 3 and 5 years time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01233453
Brief Title
Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent
Acronym
COMPARE-II
Official Title
Comparison of the Everolimus Eluting (XIENCE-V®, XIENCE-Prime® or PROMUS® Stent) With the Biolimus A9 Eluting NOBORI® Stent in All-comers: a Randomized Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maasstad Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.
Detailed Description
The main objective of the study is a head to head comparison of the everolimus eluting XIENCE-V ®, XIENCE-Prime® or PROMUS ® stent with the biolimus A9 eluting NOBORI® stent in order to observe whether there is a difference in clinical outcome between both stents in a real world / all-comer situation.
Clinical outcome of both stents will be assessed by the composite end point of: cardiac death, non fatal myocardial infarction and target vessel revascularization.
Endpoints
The primary end point of the study is the composite of safety (cardiac death, non fatal myocardial infarction) and efficacy (target vessel revascularization) at 12 months.
The secondary end points of the study are:
A) The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 12 months follow-up.
B) Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years C) Target lesion revascularization at 12 months, 3 and 5 years D) The combined endpoint of cardiac death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 3 and 5 years follow-up.
E) The combined endpoint of cardiac death, non fatal myocardial infarction and target vessel revascularization at 12 months, 3 and 5 years in STEMI patients, small vessels (< 2.75 mm RVD), long lesions (> 20 mm), female patients, DM patients and octogenarians. F) Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.
G) Incidence of definite and probable stent thrombosis at 12 months, 3 and 5 years time.
H) Incidence of definite, probable and possible stent thrombosis at 12 months, 3 and5 years time.
Overview of the study
This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.
The study population will consist of approximately 2700 patients (1 year enrollment of consecutive all-comers referred for percutaneous coronary intervention (PCI) with coronary artery or by-pass grafts lesions). Patients must meet all eligibility criteria for inclusion into the study.
Randomization will be performed by using a closed envelope with code N for the NOBORI stent and code E for the Everolimus eluting stent. Duration of the study The enrollment phase will start January 2009 and will stop December 2010. The followup phase will last till December 2015.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the everolimus eluting ® stent
Arm Type
Active Comparator
Arm Description
the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent
Arm Title
Biolimus A9 stent
Arm Type
Active Comparator
Arm Description
the Biolimus A9 eluting NOBORI® stent
Intervention Type
Device
Intervention Name(s)
the everolimus eluting ® stent
Intervention Description
stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent
Intervention Type
Device
Intervention Name(s)
the Biolimus A9 eluting NOBORI® stent
Intervention Description
stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent
Primary Outcome Measure Information:
Title
Major adverse coronary events
Description
composite of cardiac death, non fatal myocardial infarction and target vessel revascularization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Major adverse coronary events
Description
The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 12 months follow-up.
Time Frame
12 months
Title
Safety of stenting with drug eluting stents
Description
Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years
Time Frame
5 years
Title
Target lesion revascularization
Description
Target lesion revascularization at 12 months, 3 and 5 years
Time Frame
5 years
Title
Late major adverse coronary events
Description
The combined endpoint of cardiac death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 3 and 5 years follow-up.
Time Frame
5 years
Title
Major adverse coronary events in subgroups
Description
The combined endpoint of cardiac death, non fatal myocardial infarction and target vessel revascularization at 12 months, 3 and 5 years in STEMI patients, small vessels (< 2.75 mm RVD), long lesions (> 20 mm), female patients, DM patients and octogenarians
Time Frame
5 years
Title
Procedural performance
Description
Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.
Time Frame
1 year
Title
Stent Thrombosis
Description
Incidence of definite and probable stent thrombosis at 12 months, 3 and 5 years time.
Incidence of definite, probable or possible stent thrombosis at 12 months, 3 and 5 years time
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is at least 18 years old and has a life expectancy of 5 years.
Patient undergoes a PCI procedure for indications according to the Dutch and European guidelines
Patient is willing to comply with the extended follow-up period of 2 to 5 years(for secondary endpoint only)
Reference lumen diameter of the treated vessels between 2.0 - 4.0 mm.
Informed consent
Exclusion Criteria:
Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
Expected major surgery within 30 days (these patients will receive bare metal stents)
Cardiogenic shock (Kilip class 4)
Previous PCI procedures with implantation of drug eluting stents within 1 year.
Expected loss for follow up
Enrollment in an investigative stent study with different stents
Inability to implant Nobori or Xience-V / Promus stent(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter C Smits, MD, PHD
Organizational Affiliation
Maasstad Ziekenhuis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A Serra, MD
Organizational Affiliation
Hospital del Mar
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
A J van Boven, MD, PHD
Organizational Affiliation
Medisch Centrum Leeuwarden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
J J Goy, MD
Organizational Affiliation
Hopital Cantonal de Fribourg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
V Voudris, MD
Organizational Affiliation
Onassis Heart Centre, Athens
Official's Role
Study Chair
Facility Information:
Facility Name
Onassis cardiac Surgery Centre
City
Athens
Country
Greece
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
Maasstad Hospital
City
Rotterdam
Country
Netherlands
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Complejo Hospitalario Universitario Juan Canalejo
City
Coruña
Country
Spain
Facility Name
Hospital Universitario Virgen Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Clinico universitario de Santiago de Compostella
City
Santiago de Compostella
Country
Spain
Facility Name
Kantonsspital Aarau
City
Aarau
Country
Switzerland
Facility Name
Hopital Cantonal de Fribourg
City
Fribourg
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26196753
Citation
Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53.
Results Reference
derived
PubMed Identifier
23374650
Citation
Smits PC, Hofma S, Togni M, Vazquez N, Valdes M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer P, van der Ent M. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013 Feb 23;381(9867):651-60. doi: 10.1016/S0140-6736(12)61852-2. Epub 2013 Jan 30.
Results Reference
derived
Learn more about this trial
Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent
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