DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity (DUTCHPEERS)
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.
To investigate whether the clinical outcome is similar after implantation of the Promus Element versus the Resolute Integrity stent (non-inferiority hypothesis).
Multicenter, prospective, randomized single-blinded study.
Patients who require percutaneous coronary interventions (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.
In patients who are eligible for DES implantation, the type of DES implanted will be randomized (Resolute Integrity stent versus Promus Element stent). At the start of the study, both DES will also be used in routine clinical practice.
Main study endpoints:
The primary endpoint is the incidence of target vessel failure at one year follow-up. Target vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI, or clinically driven target vessel revascularization. Further secondary clinical and angiographic endpoints will be investigated, defined in accordance with suggestions of the Academic Research Consortium (ARC). Of note, the angiographic assessment is based on clinically indicated projections only and results in no additional x-ray exposure. There is no routine angiographic follow-up. If angiographic data are available in patients who undergo symptom-driven re-catheterization, we will analyze these data to get insight into the mechanisms of potential DES restenosis.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
Coronary Artery Disease
Unstable Angina Pectoris
Acute Coronary Syndrome
Device: Resolute Integrity®
Device: Promus Element®
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All-Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2).|
- Target-vessel failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 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;
- Clinically driven repeated target vessel revascularization by means of CABG or PCI.
- Death at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: Yes ]Death distinguished into: cardiac, vascular, other causes, all-cause mortality
- Myocardial infarction at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: Yes ]Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction
- Revascularization at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: No ]Target-vessel revascularization distinguished into PCI or CABG
- Stent thrombosis at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: Yes ]Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition.
- Longitudinal stent deformation [ Time Frame: 1 year ] [ Designated as safety issue: No ]Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||May 2017|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Resolute Integrity®
The coating of Resolute Integrity consists of zotarolimus as antiproliferative agent and the BioLinx® polymer system. This polymer system consists of a blend of three different polymers: (1) the hydrophobic C10 polymer, which aids in the control of drug release; (2) the hydrophilic C19 polymer, which supports biocompatibility; and (3) polyvinyl pyrro-lidinone, which increases the initial drug burst and enhances the elution rate.
Device: Resolute Integrity®
Biolinx-zotarolimus coating on a chobalt-cromium alloy stent platform that has a novel sinusoidal design.
Other Name: Resolute Integrity® drug eluting stent
Active Comparator: Promus Element®
Promus Element utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation.
Promus Element is composed of the Element platform, a thin fluoropolymer coating, and Everolimus.
Device: Promus Element®
fluoropolymer-everolimus coating on a novel stent platform made from a platinum-chromium alloy
Other Name: Promus Element® drug eluting stent
Please refer to this study by its ClinicalTrials.gov identifier: NCT02175706
|Medisch Centrum Alkmaar|
|Medisch Spectrum Twente|
|Principal Investigator:||Clemens von Birgelen, MD,PhD,Prof||Thorax Centrum Twente|