Coronary Artery Disease Clinical Trial
Official title:
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
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 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.
rationale: 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
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.
Aim:
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
all-comers patient population and non-inferiority setting.
Study design:
The study is a prospective, randomized, single-blinded, multicentre trial with 1:1
randomization for drug-eluting stent type, stratified for gender and the presence of
diabetes mellitus.
Study population:
Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary
stenoses with an indication for DES use, according to current guidelines and/or the
operators clinical judgement. All clinical syndromes will be included. A total of 2,470
patients will be included.
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.
Primary study 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 coronary artery bypass grafting (CABG).
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