Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent

NCT ID: NCT01233453

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the everolimus eluting ® stent

the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent

Group Type: ACTIVE_COMPARATOR

the everolimus eluting ® stent

Intervention Type: DEVICE

stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent

Biolimus A9 stent

the Biolimus A9 eluting NOBORI® stent

Group Type: ACTIVE_COMPARATOR

the Biolimus A9 eluting NOBORI® stent

Intervention Type: DEVICE

stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent

Interventions

the everolimus eluting ® stent

stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent

Intervention Type: DEVICE

the Biolimus A9 eluting NOBORI® stent

stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maasstad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pieter C Smits, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Maasstad Ziekenhuis

A Serra, MD

Role: STUDY_CHAIR

Hospital del Mar

A J van Boven, MD, PHD

Role: STUDY_CHAIR

Medisch Centrum Leeuwarden

J J Goy, MD

Role: STUDY_CHAIR

Hopital Cantonal de Fribourg

V Voudris, MD

Role: STUDY_CHAIR

Onassis Heart Centre, Athens

Locations

Onassis cardiac Surgery Centre

Athens, , Greece

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Maasstad Hospital

Rotterdam, , Netherlands

Complejo Hospitalario Universitario Juan Canalejo

A Coruña, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario Virgen Arrixaca

Murcia, , Spain

Hospital Clinico universitario de Santiago de Compostella

Santiago de Compostela, , Spain

Kantonsspital Aarau

Aarau, , Switzerland

Hopital Cantonal de Fribourg

Fribourg, , Switzerland

Countries

Greece; Netherlands; Spain; Switzerland

References

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.

Reference Type: DERIVED

PMID: 26196753 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23374650 (View on PubMed)

Other Identifiers

NL25754.101.08

Identifier Type: -

Identifier Source: org_study_id