Coronary Artery Disease Clinical Trial
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).
Rationale:
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.
Objective:
To investigate whether the clinical outcome is similar after implantation of the Promus
Element versus the Resolute Integrity stent (non-inferiority hypothesis).
Study design:
Multicenter, prospective, randomized single-blinded study.
Study population:
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.
Intervention:
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.
1. OBJECTIVES
Primary research questions To investigate whether the outcome after the randomized
implantation of the Resolute Integrity versus Promus Element drug-eluting stent are
similar, as assessed in a non-inferiority setting by comparing target-vessel failure
(TVF) of both stents at one year follow-up post stent implantation. In brief, we want
to compare for both drug-eluting stents the combined endpoint of (1) cardiac death, (2)
myocardial infarction that can be related to the target vessel or cannot be related to
another vessel, and (3) clinically indicated revascularization related to the
target-vessel. Based on the results of the RESOLUTE all-comers trial (the study stents
in the RESOLUTE all comers trial used the same coatings and drugs used in the current
trial but on different bare metal stent platforms), non-inferiority of Resolute
Integrity and Promus Element is expected. This is not tested in a controlled randomized
trial yet.
Secondary research questions Effectivity, safety, clinical short- and long-term
outcome, and the acute angiographic results of the implantation of two third-generation
drug-eluting stents will be compared in a "real world", all-comers scenario.
Angiographic comparison will be based on the routine coronary angiography runs recorded
during diagnostic coronary angiography and PCI procedures. No additional mandatory
angiographic studies after the index PCI are required.
2. STUDY DESIGN
The DUTCH PEERS Study is a multi-center prospective single-blinded randomized study.
Randomization will involve the type of DES used in study population. Patients will be
blinded to the type DES they will receive. The general practitioner of the patient will
be requested not to disclose this information to the patient. Analysts who perform the
data analyses will be blinded to the type DES used as well.
3. STUDY POPULATION 3.1 Population (base) All patients who fulfil the inclusion criteria
and undergo PCI with potential DES implantation will be asked to participate in the
DUTCH PEERS, unless they meet one or more of the exclusion criteria.
Patients will receive a drug-eluting stent according to the guidelines (Guidelines NVVC/ESC)
and/or the clinical decision of the interventional cardiologist.
3.2 Inclusion criteria
- Minimum age of 18 years
- Coronary artery disease and lesion(s) eligable for treatment with drug eluting stents
according to clinical guidelines and/or the operators' judgement
- Patient is willing and able to cooperate with study procedures and required follow-up
visits; and patient has been informed and agrees on the participation by signing an EC
approved written informed consent.
3.3 Exclusion criteria
- Participation in another randomized drug or device study before reaching primary
endpoint
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained
throughout the peri-surgical period
- intolerance to a P2Y12 receptor antagonist that results in the patient's inability to
adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components
of the two DES examined.
- Known pregnancy
- Life expectancy of less than 1 year
4.1 Randomisation, blinding and treatment allocation Patients will be randomised by a
computer program (block stratified randomization V5.0 by S. Piantadosi). The randomisation
will be done in blocks of 8 and 4 in random order. No stratification will be employed. The
study will be single blinded because the physician will know which stent is implanted. The
patient will not know. Every attempt will be made to do all outcome assessments blinded. The
analyst performing QCA and IVUS analysis will be blinded to the type of DES used.
Demographics and Medical Data
At baseline the data are collected by the researchers, research nurses, and/or nurse
practitioners. Demographic and medical data are also collected by reviewing the patient's
medical chart:
- demographics including: date of birth, gender, family history of cardiovascular
disease, smoking habits;
- medical history including: arterial hypertension, diabetes mellitus,
hypercholesterolemia, previous myocardial infarction, previous revascularization by
means of CABG / PCI, previous cerebrovascular accident (CVA) or transient ischemic
attack (TIA), renal failure requiring haemodialysis;
- current medication;
- body-mass index, arterial blood pressure, heart frequency;
- indication for PCI;
- symptoms prior to PCI: angina pectoris (CCS class), dyspnea (NYHA class).
Blood samples Laboratory tests will be performed in the local laboratories of the
participating centres as part of their clinical routine practice. In elective and primary
PCI before and the day after the PCI procedure, blood tests will be performed (assessment of
Hb, Kreatinine, CK, CK-MB, and Troponines). If patients suffer from persistent chest pain
after PCI, additional controls of the cardiac markers will be performed on the day of PCI as
part of the clinical routine. In case of symptoms suspicious of an acute coronary event in
patients scheduled for elective PCI, the assessment of cardiac markers prior to PCI is
considered as good clinical practice and should be performed.
PCI procedure Routine PCI will be performed according to routine medical practice in
including centres with no deviation from routine protocols. No additional angiographic views
will be required. Patients will receive one or more DES during PCI. The type of DES used
during PCI will be randomized. Detailed technical information on PCI procedures are provided
in the current European society of cardiology guidelines of PCI. [27] If clinically
indicated, IVUS-guidance will be used during PCI.
Mixture of stents should be avoided and is only permitted if the operator is unable to
insert the study stent, in which case crossover to another non-study stent is possible.
Treatment of all coronary lesions should be aimed in one session, however staged procedures
(defined as procedures planned at the time of the index procedure and performed within 6
weeks with the same type of study stent) will be permitted. In case of unplanned
revascularization procedures requiring stent implantation, it is recommended that physicians
use the same study stent.
Medical therapy Medical therapy does not differ from current routine medical treatment. In
brief, patients who are not on oral aspirin therapy receive a loading dose of at least 300
mg prior to PCI. In elective PCI patients, clopidogrel therapy of 75 mg daily is started one
week before the PCI. In urgent PCI, a loading dose of 600 mg clopidogrel is given as soon as
possible, either before PCI or (at least) directly after the PCI is performed. In case
prasugrel is used, patients will receive a loading dose of 60 mg of prasugrel followed by a
daily dose of 10 mg for at least 12 months. Directly prior to PCI, an adequate dose of
unfractionated heparin is administered i.v. or i.a. In general, an intracoronary bolus of
nitrates will be administered prior to PCI. The use of glycoprotein IIb/IIIa inhibitors is
left at the operators' discretion. Following the index PCI procedure, patients are generally
maintained on aspirin >=80 mg daily during the entire trial (and preferably lifelong). In
general, clopidogrel 75 mg daily is recommended and prescribed for a period of 12 months in
addition to aspirin. If patients require oral anticoagulation therapy (e.g. for atrial
fibrillation), aspirin >=80 mg daily is prescribed for one month after PCI and clopidogrel
for 12 months. Further medical treatment is performed according to current medical
guidelines, clinical standards, and the judgment of the referring physicians.
Follow-up data collection Follow-up data will be collected during routine visits to
outpatient clinic and/or phone calls. If no data are available from outpatient clinic
visits, the required data will be collected through a phone call. The phone call follow-up
will be conducted through blinded members of the research team (nurse practicioners,
cardioresearch personnel or research fellows). Through an outpatient clinic visit or a
telephone call patients will be asked about recurrence of symptoms or new symptoms which can
indicate the presence of restenosis. Patients will be also asked about possible
revascularization or myocardial infarction during the follow-up period. In case of death,
information will be obtained from the patient's medical chart, GP or cardiologist. Patients
will be called after 1 month, 12 months and 24 months. The mode of data acquisition of the
follow up (telephone or outpatient visit) will be registered.
In order to determine whether a myocardial infarction is related or unrelated to the target
vessel, a Critical Events Committee consisting of two independent cardiologists will be
asked to provide an independent conclusion about the location of an infarction on the
electrocardiogram.
Adverse events, comprised by the primary endpoint, will be monitored by an independent
external contract research organisation. In addition, we intend that secondary clinical
endpoints of at least 10% of patients will be monitored, too.
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