arteriosclerose hardening of the arteries
Conditions
Interventions
No intervention
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients of 18 years and older, requiring PCI for the treatment of significant coronary artery or bypass graft lesions, being eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators* judgement, and capable of providing informed consent. Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.
Exclusion criteria
Exclusion criteria: Known intolerance to components of one of the stents that will be investigated, or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy. Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization. Participation in another randomized drug or device trial before reaching primary endpoint. Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year. Known pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions). Components of the primary endpoint in hierarchical order: o Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. o Target vessel related MI 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Death (any/ cardiac/ non-cardiac) at 1 to 5 years follow-up • MI (any/ Q-wave/ non-Q-wave) and target vessel-related MI according to the ARC definition and its addendum (CKmax >2x ULN) at 1 to 5 years follow-up • Revascularization (any/ by PCI/ by CABG) at 1 to 5 years follow-up • Clinically-indicated target vessel revascularization (TVR) (any/ by PCI/ by CABG) at 1 to 5 years follow-up • Clinically-indicated target lesion revascularization (TLR) (any/ by PCI/ by CABG) at 1 to 5 years follow-up • Stent thrombosis (ST) (definite/ probable/ possible/ definite-or-probable) according to ARC definitions at 1 to 5 years follow-up • Time of ST (acute/ subacute/ late/ very late) according to ARC definitions • Target lesion failure (TLF) (composite endpoint consisting of cardiac death; target vessel-related MI; clinically driven TLR) at 1 to 5 years follow-up • Major adverse cardiac events (device oriented MACE; composite endpoint consisting of any death; any MI; emergent CABG or clinically indicated TLR) at 1 to 5 years follow-up • Patient-oriented composite endpoint (patient-oriented MACE; composite endpoint consisting of any death; any MI; any revascularization) at 1 to 5 years follow-up | — |
Countries
Netherlands
Outcome results
None listed