Clinical trial NCT01233453: Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Maasstad Hospital
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Major adverse coronary events
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse coronary events
timeFrame: 12 months
measure: Safety of stenting with drug eluting stents
timeFrame: 5 years
measure: Target lesion revascularization
timeFrame: 5 years
measure: Late major adverse coronary events
timeFrame: 5 years
measure: Major adverse coronary events in subgroups
timeFrame: 5 years
measure: Procedural performance
timeFrame: 1 year
measure: Stent Thrombosis
timeFrame: 5 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Onassis cardiac Surgery Centre
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario Juan Canalejo
city: Murcia
country: Spain
facility: Hospital Universitario Virgen Arrixaca
city: Santiago de Compostella
country: Spain
facility: Hospital Clinico universitario de Santiago de Compostella
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Fribourg
country: Switzerland
facility: Hopital Cantonal de Fribourg
Study officials:
affiliation: Maasstad Ziekenhuis
name: Pieter C Smits, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: A Serra, MD
role: STUDY_CHAIR
affiliation: Medisch Centrum Leeuwarden
name: A J van Boven, MD, PHD
role: STUDY_CHAIR
affiliation: Hopital Cantonal de Fribourg
name: J J Goy, MD
role: STUDY_CHAIR
affiliation: Onassis Heart Centre, Athens
name: V Voudris, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.