The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an allcomers patient population and non-inferiority setting.
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:
- Cardiac death: all deaths are considered cardiac, unless an unequivocal
non-cardiac cause can be established.
- Target vessel related myocardial infarction (MI) that is Q-wave or
non-Q-wave, that can be related to the target vessel or cannot be related to
another vessel.
- Clinically driven repeated target vessel revascularization by means of PCI or
CABG.
Secondary outcome
- Target vessel failure (TVF) at 2-year follow-up (TVF at 2-year follow-up is
a Major Secondary Endpoint)
- Death (any / cardiac / non-cardiac)
- Target vessel-related MI (any / periprocedural) and any MI, according to the
current (as of March 2015) ARC definition and addendum (CKmax >2x ULN)
- Clinically-indicated target vessel revascularization (TVR) (any / by PCI / by
CABG)
- Clinically-indicated target lesion revascularization (TLR) (any / by PCI / by
CABG)
- Any Revascularization (any / by PCI / by CABG)
- Stent thrombosis (ST) (definite / probable / possible/ definite-or-probable)
and time of ST (acute / sub-acute / late / very late) according to the ARC
definitions.
- Target lesion failure (TLF) (composite endpoint consisting of cardiac death;
target vessel-related MI; clinically driven TLR)
- Major adverse cardiac events (MACE; device oriented MACE composite endpoint;
composite endpoint consisting of any death; any MI; emergent CABG or clinically
indicated TLR)
- Patient-oriented composite endpoint (POCE; patient-oriented MACE; composite
endpoint consisting of any death; any MI; any revascularization)
- Periprocedural MI rates according to alternative definitions such as the
SCAI definition, the 3rd Universal Definition of MI, or another (then updated)
definition will be reported as additional information
- Major bleeding: bleedings that require surgery or blood transfusions, or
cerebral hemorrhages) as defined by ARC criteria as well as the Thrombolysis in
Myocardial Infarction (TIMI) criteria19:
* Major bleeding (TIMI)
* Type 3 and 5 (ARC)
Incidence of longitudinal stent deformation (LSD) and deliverability
- Angiographic core lab-identified LSD, as previously defined (von Birgelen et
al., Lancet 2014); mechanisms (compression and/or elongation), characteristics,
clinical outcome
- Operator-reported LSD
- Deliverability of the assigned study stent
Patient-reported chest pain score (CPS)
- Prevalence of patient-reported chest pain at annual follow-up
- Chest pain score at annual follow-up (definitions in analogy with the DUTCH
PEERS TWENTE II 2- year analysis, reported by Sen et al. in JACC Cardiovasc
Interv. 2015; 8: 889-899.)
- Changes thereof over time
- The cumulative incidence
- Relation with coronary revascularizations and with MACE and POCE
Patient-reported dyspnea score (DPS)
- Prevalence of patient-reported dyspnea at the predefined moments of follow-up
Secondary endpoints (except LSD) will be assessed annually.
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
advers events also led to the development of DES with bioresorbable 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
bioresorbable polymer DES are increasingly used in clinical practice, data from
head-to-head comparisons between bioresorbable polymer DES with a contemporary
highly flexible new generation permanent polymer coated DES.
Study objective
The aim of the study is to compare the outcome of the bioresorbable polymer
coated stent (ORSIRO) and a new generation permanent polymer coated stent
(RESOLUTE ONYX) in an allcomers patient population and non-inferiority setting.
Study design
Prospective, randomized, single-blinded, multicentre trial with 1:1
randomization for drug-eluting stent type, stratified for gender and the
presence of diabetes mellitus.
Intervention
One group will receive the ORSIRO stent, the other group will receive the
RESOLUTE ONYX stent. All other intervention and procedural characteristics are
similar. Both interventions are in accordance with the standard guidelines for
PCI and both stents are used for regular treatment outside this study as well.
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 lenth of lesions to be treated.
Exclusion criteria
Known intolerance to components of one of the study DES, or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to any dual anti-platelet therapy (DAPT).
Planned elective surgical procedure necessitating interruption of DAPT during the first 3 months after randomization.
Participation in another randomized cardiovascular device trial or randomized pharmacological study related to antithrombotic and/or anticoagulant therapy before reaching the primary endpoint. Known pregnancy, adherence to scheduled follow-up is unlikely, or life expectancy is assumed to be less than 1 year
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 | NCT02508714 |
| CCMO | NL54076.044.15 |