The aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
• 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
Background summary
The introduction of drug-eluting stents (DES) in the treatment of coronary
artery disease has led to a significant reduction in morbidity. However, the
first generation of these devices had no positive impact on the mortality after
PCI (compared to bare metal stents), which was greatly attributed to a somewhat
increased incidence of late and very late stent thrombosis. Concerns about the
role of durable polymers as a potential trigger of inflammation and finally
adverse events also led to the development of DES with biodegradable coatings,
which leave after degradation of the coating only a bare metal stent in the
vessel wall that does not induce an inflammatory response. While such
biodegradable polymer DES are increasingly used in clinical practice, there is
no data available from head-to-head comparisons between biodegradable and
contemporary third generation durable polymer DES.
Study objective
The aim of the study is to compare the outcome of two DES with biodegradable
polymer coatings separately (Orsiro and Synergy) versus an established
third-generation durable polymer DES with proven efficacy and safety (Resolute
Integrity) in an all comers patient population and non-inferiority setting.
Study design
Prospective, randomized, single-blinded multicentre trial with 1:1:1
randomization for drug-eluting stent type, stratified for the presence of
diabetes mellitus.
Intervention
No intervention
Study burden and risks
Patients will receive the routine clinical treatment. As a consequence, the
risks of this trial do not exceed the risks of any routine PCI procedure.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01674803 |
| CCMO | NL41558.044.12 |