Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01233453
• Other study ID #: NL25754.101.08
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: January 29, 2014
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: Maasstad Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2700
• Est. completion date: December 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• the everolimus eluting ® stent
stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent
• the Biolimus A9 eluting NOBORI® stent
stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent

Locations

Country	Name	City	State
Greece	Onassis cardiac Surgery Centre	Athens
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Maasstad Hospital	Rotterdam
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
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Hopital Cantonal de Fribourg	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
Maasstad Hospital

Countries where clinical trial is conducted

Greece,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse coronary events	composite of cardiac death, non fatal myocardial infarction and target vessel revascularization	12 months	Yes
Secondary	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.	12 months	Yes
Secondary	Safety of stenting with drug eluting stents	Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years	5 years	Yes
Secondary	Target lesion revascularization	Target lesion revascularization at 12 months, 3 and 5 years	5 years	No
Secondary	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.	5 years	Yes
Secondary	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	5 years	Yes
Secondary	Procedural performance	Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.	1 year	No
Secondary	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	5 years	Yes