Coronary atherosclerosis Percutanous Coronary Intervention Drug-eluting Stent
Conditions
Interventions
Intervention will involve randomization of the type of DES ( Endeavor Resolute vs XIENCE V) used in study population. Duration of randomization will be two years.
Sponsors
Prof. dr. C. von Birgelen
Medisch Spectrum Twente
Haaksbergerstraat 55
7513 ER Enschede
the Netherlands
e-mail: c.vonbirgelen@ziekenhuis-mst.nl
Telephone: +31 53 487 2105
Fax: +31 53 487 2107
Eligibility
Inclusion criteria
Inclusion criteria: 1. Indication for PCI with DES implantation based on NVVC/ESC guidelines and/or clinical decision of interventional cardiologist 2. Age ≥ 18 years and mentally capable to give an informed consent 3. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with ST-elevation myocardial infarction (STEMI) or an ST-elevation myocardial infarction equivalent requiring primary PCI or rescue PCI 2. Patients in whom the revascularization procedure is planned to be performed in a staged approach 3. Renal failure requiring haemodialysis 4. Patient is currently participating in an investigational drug or device study that has been not completed 5. In the investigators opinion patient has a co-morbid condition(s) that could limit the patient’s ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study 6. Life expectancy less than 1 year 7. Patients in whom during PCI there is no indication for DES use and/or if the operator chooses not to use a DES based on the clinical situation, the patient will be excluded 8. When the choice of DES is dictated by logistic reasons e.g. the required DES dimensions is provided by one manufacturer only and not by the other.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: • Target vessel failure (TVF) at 12 months (according to ARC definitions) Components of the primary endpoint in hierarchical order: o Target vessel related death or cardiac death that cannot be clearly attributed to a vessel other than the target vessel. All deaths are considered cardiac, unless an unequivocal noncardiac cause can be established. o Target vessel related MI (n,%), that is Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel. o Clinically driven repeated target vessel revascularization by means of CABG or PCI (n,%) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical endpoints at one and three month and 1 and 2 year follow-up (with the exception of TVF at 1 year which is the primary endpoint, as described above): o Death:  Cardiac  Vascular  Other causes  All-cause mortality o Any myocardial infarction:  Q-wave  Non Q-wave o Any revascularisation by means of PCI or Coronary Artery Bypass Grafting (CABG). o Target vessel related death o Target vessel related myocardial infarction (MI) (n,%):  Q-wave myocardial infarction  Non Q-wave myocardial infarction o Clinically indicated repeated target vessel revascularization (TVR): • CABG • PCI o Clinically indicated repeated target lesion revascularization (TLR): • CABG • PCI oNew onset of angina pectoris:  Related to the target vessel.  Related to another vessel.  Unspecified. oStent thrombosis (Definite, Probable, and Possible; ARC definition):  Early  Subacute  Late  Very late • Composite endpoint at one and three month and 1 and 2 year follow-up (except TVF at one year follow-up which is already the primary endpoint): o Target vessel failure (TVF) as defined above. o Major Adverse Cardiac Events (MACE), patient oriented ( hierarchical order):  All cause mortality.  Any MI (including nontarget vessel territory)  Any repeat revascularization (target and nontarget vessels) by means of CABG or PCI o MACE, device/lesion oriented ( hierarchical order):  Cardiac death  MI not clearly attributable to a nontarget vessel  Target lesion revascularization (TLR) • Angiographic endpoints in entire population at final angiographic assessment : o At final angiographic assessment the stented segment will be subdivided into 3 equally sized subsegments in which the individual minimum lumen diameter (MLD), reference diameter, percent diameter stenosis (% D | — |
Contacts
Public ContactH. Verheij
Medisch Spectrum Twente Haaksbergerstraat 55
Outcome results
None listed