Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent (COMPARE-II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01233453
First received: October 28, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: the everolimus eluting ® stent
Device: the Biolimus A9 eluting NOBORI® stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Maasstad Hospital:

Primary Outcome Measures:
  • Major adverse coronary events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    composite of cardiac death, non fatal myocardial infarction and target vessel revascularization


Secondary Outcome Measures:
  • Major adverse coronary events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years

  • Target lesion revascularization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Target lesion revascularization at 12 months, 3 and 5 years

  • Late major adverse coronary events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.

  • Stent Thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 2700
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: the everolimus eluting ® stent
the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent
Device: the everolimus eluting ® stent
stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent
Active Comparator: Biolimus A9 stent
the Biolimus A9 eluting NOBORI® stent
Device: the Biolimus A9 eluting NOBORI® stent
stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is at least 18 years old and has a life expectancy of 5 years.
  2. Patient undergoes a PCI procedure for indications according to the Dutch and European guidelines
  3. Patient is willing to comply with the extended follow-up period of 2 to 5 years(for secondary endpoint only)
  4. Reference lumen diameter of the treated vessels between 2.0 - 4.0 mm.
  5. Informed consent

Exclusion Criteria:

  1. Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
  2. Expected major surgery within 30 days (these patients will receive bare metal stents)
  3. Cardiogenic shock (Kilip class 4)
  4. Previous PCI procedures with implantation of drug eluting stents within 1 year.
  5. Expected loss for follow up
  6. Enrollment in an investigative stent study with different stents
  7. Inability to implant Nobori or Xience-V / Promus stent(s)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233453

Locations
Greece
Onassis cardiac Surgery Centre
Athens, Greece
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Spain
Hospital del Mar
Barcelona, Spain
Complejo Hospitalario Universitario Juan Canalejo
Coruña, Spain
Hospital Universitario Virgen Arrixaca
Murcia, Spain
Hospital Clinico universitario de Santiago de Compostella
Santiago de Compostella, Spain
Switzerland
Kantonsspital Aarau
Aarau, Switzerland
Hopital Cantonal de Fribourg
Fribourg, Switzerland
Sponsors and Collaborators
Maasstad Hospital
Investigators
Principal Investigator: Pieter C Smits, MD, PHD Maasstad Ziekenhuis
Study Chair: A Serra, MD Hospital del Mar
Study Chair: A J van Boven, MD, PHD Medisch Centrum Leeuwarden
Study Chair: J J Goy, MD Hopital Cantonal de Fribourg
Study Chair: V Voudris, MD Onassis Heart Centre, Athens
  More Information

No publications provided by Maasstad Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maasstad Hospital
ClinicalTrials.gov Identifier: NCT01233453     History of Changes
Other Study ID Numbers: NL25754.101.08
Study First Received: October 28, 2010
Last Updated: January 29, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014