Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: the everolimus eluting ® stent
* Device: the Biolimus A9 eluting NOBORI® stent


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the everolimus eluting ® stent<br>the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent | Device: the everolimus eluting ® stent<br>* stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent<br>|
| Active Comparator: Biolimus A9 stent<br>the Biolimus A9 eluting NOBORI® stent | Device: the Biolimus A9 eluting NOBORI® stent<br>* stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse coronary events | composite of cardiac death, non fatal myocardial infarction and target vessel revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Target lesion revascularization | Target lesion revascularization at 12 months, 3 and 5 years | 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. | 5 years | 
| 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 | 
| Procedural performance | Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent. | 1 year | 
| 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 |