Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent
- Conditions
- Coronary Artery Disease
- Interventions
- Device: the everolimus eluting ® stentDevice: the Biolimus A9 eluting NOBORI® stent
- Registration Number
- NCT01233453
- Lead Sponsor
- Maasstad Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2700
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the everolimus eluting ® stent the everolimus eluting ® stent the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent Biolimus A9 stent the Biolimus A9 eluting NOBORI® stent the Biolimus A9 eluting NOBORI® stent
- Primary Outcome Measures
Name Time Method Major adverse coronary events 12 months composite of cardiac death, non fatal myocardial infarction and target vessel revascularization
- Secondary Outcome Measures
Name Time Method Major adverse coronary events 12 months 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 5 years Incidence of Cardiac Death and Post-Procedural (\>48h) MI rate at 12 months, 3 and 5 years
Target lesion revascularization 5 years Target lesion revascularization at 12 months, 3 and 5 years
Late major adverse coronary events 5 years 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 5 years 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 1 year Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.
Stent Thrombosis 5 years 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
Trial Locations
- Locations (11)
Onassis cardiac Surgery Centre
🇬🇷Athens, Greece
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Hopital Cantonal de Fribourg
🇨🇭Fribourg, Switzerland
Complejo Hospitalario Universitario Juan Canalejo
🇪🇸Coruña, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clinico universitario de Santiago de Compostella
🇪🇸Santiago de Compostella, Spain
Hospital Universitario Virgen Arrixaca
🇪🇸Murcia, Spain