1- To determine whether PCI of the CTO will yield a higher reduction of ischemia assessed by exercise myocardial perfusion SPECT from baseline to follow-up compared to a control group. 2- To evaluate the effect of PCI of the CTO on improvement in…
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Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the REVISE-CTO study is to determine whether in CTO
patients, selected with a ischemic threshold, PCI of the CTO results in a
greater reduction of the ischemic burden assessed with exercise myocardial
perfusion SPECT from baseline to 6 months follow-up compared to a control group
(OMT only).
Secondary outcome
Secondary objectives are:
To assess the effect of PCI of the CTO compared to the control group on:
1) Functional outcome: (angina) symptoms, quality of life, cardio-pulmonary
exercise capacity.
2) Left ventricular function: global function, segmental wall thickening and
infarct size.
3) Ventricular repolarization ECG markers on rest and exercise ECG.
Objectives from the collateral study performed in patients undergoing PCI of
the CTO (n=41).
To assess the influence of collaterals on:
4) Myocardial ischemia at baseline and follow-up assessed with exercise
myocardial perfusion SPECT and compare the parameters in the CTO with the
remote area.
5) Functional outcome, global and regional left ventricular function and
infarct size
Clinical objectives from the registry and randomized trial:
7) All outcomes will be stratified for gender and the prospective registry data
will be used to evaluate the different CTO treatment strategies and outcomes in
women compared to men
8) Safety endpoints and major clinical cardiac events will be registered and
compared between treatment strategies
Background summary
A chronic total occlusion (CTO) is a 100% (complete) chronic coronary artery
blockage and present in about 20% of patients with coronary artery disease
(CAD). Patients with a CTO have a worse clinical outcome compared to non-CTO
patients, irrespective of age or other co-morbidities. Currently CTO lesions
are more often treated by percutaneous coronary intervention (PCI) in routine
clinical practice, leading to expensive dedicated CTO programs and improvements
in procedural techniques and devices. However whether PCI is the optimal
treatment of CTO patients remains controversial, as there are increased
complication risks with thus far no clear clinical benefit. Also the blood flow
from collateral arteries is believed to be sufficient to prevent ischemia and
preserve function of the CTO territory. However, while in resting conditions
this may be adequate, during exercise the collaterals fail to supply the
myocardium and patients will experience ischemia reducing their
exercise-capacity and quality of life. Although observational data showed
benefit of successful PCI of the CTO, none of the randomized CTO trials found
clinical benefit compared to optimal medical therapy (OMT) only, though a
beneficial effect on angina reduction was found. This has energized the theory
that a pre-treatment ischemic substrate (threshold) is required to justify CTO
revascularization. In post-hoc analysis PCI led to a greater ischemia reduction
compared to OMT and ischemia reduction was associated with improved outcome.
Currently only limited data is available on the effect of PCI of the CTO on
ischemia reduction and subsequent functional outcome, and no comparison exist
with a control group. Furthermore there is insufficient insight on the
association between the extent of the collateral perfusion network and the
ischemic burden in patients. Patients with a CTO constitute an unique
population to not only study the clinical effects of (PCI) treatment but also
the physiological effects on the ischemic burden reduction. These data are
highly warranted to more definitely determine the guidelines for optimal CTO
treatment.
Study objective
1- To determine whether PCI of the CTO will yield a higher reduction of
ischemia assessed by exercise myocardial perfusion SPECT from baseline to
follow-up compared to a control group.
2- To evaluate the effect of PCI of the CTO on improvement in functional
status, infarct size and left ventricular function from baseline to follow-up
compared to the control group.
3- To study the association between ischemia reduction and functional outcome
and left ventricular function.
4- To assess the influence of the collateral flow index on the ischemic burden
(reduction), functional status, infarct size and left ventricular (contractile)
function (hibernation).
Study design
In this multicentre prospective study 82 CTO patients will be randomly assigned
to the invasive arm (PCI+OMT) or to the control arm (OMT only). All patients
with a documented CTO in a native coronary artery, considered to be older than
3 months, will be prospectively screened. As part of routine clinical practice
an SPECT (ischemia) and CMR (viability) scan will be performed to determine the
clinical need for CTO revascularization. Patients are deemed eligible when they
meet the ischemic threshold in the CTO territory (defined as >12.5% of ischemia
with <50% transmural extent of infarction).
All consecutive CTO patients will be asked to be included into the prospective
registry. The registry will give a description of the current CTO management
strategies and an estimation on the risks and benefits of the different
strategies. Registry data will be analysed separately for women and men to
detect possible gender differences. All patients will be evaluated for safety
and adverse cardiac events.
Intervention
All patients will receive OMT, which focus on antianginal therapy, aiming for
at least two antianginal medications, adequate lipid-lowering therapy,
antiplatelet therapy and blood pressure lowering medication. In the control
group revascularization is only reserved in case of OMT failure (e.g.,
progressive or refractory symptoms or the development of acute coronary
syndrome). PCI will be performed according to standard clinical practice,
including antegrade and retrograde approaches at the discretion of the
operator. After successful PCI assessment of intracoronary collateral indices
pressure (CFIp) and flow (CFIv) will be performed using a pressure and flow
wire. The wire will be placed distal to the treated CTO lesion and measurements
will be performed before and during low-pressure balloon occlusion. During
low-pressure balloon occlusion the wire distal of the CTO lesion will solely
measure the pressure and flow indices from the collaterals. Measurements will
be performed during rest and maximal hyperaemia, induced by adenosine.
Collateral indices are calculated as: CFIp = (Poccl*CVP) / (Pao*CVP) and CFIv =
(CFIbaseline)/ (CFIpost*PCI)
Study burden and risks
1 visit at baseline, for inclusion (about 1 hour)
1 telephone contact for the standardized questionnaires for angina, dyspnoea
and quality of life (approx. 15 min)
1 visit after 6 months for repeat SPECT, repeat MRI, resting ECG and
standardized questionnaires (about 10 hours)
Telephone contact at 1 year and every consecutive year until 10 years follow-up
(approx. 15 min)
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. A chronic total occlusion is present and target lesion. A CTO is required to
meet the following characteristics:
• A 100% luminal narrowing of the coronary artery without antegrade flow, i.e.
Thrombolysis in Myocardial Infarction flow grade 0 or 1;
• Older than 3 months, established with previous PCI or with angiographic
characteristics;
• Amenable to percutaneous revascularization.
2. Patient has a clinical indication to perform CTO PCI.
3. A SPECT is performed at baseline to assess ischemia and a cardiac magnetic
resonance imaging (CMR) scan to assess viability, as part of routine patient
care. Patients are deemed eligible for the randomized trial when they meet the
ischemic threshold in the CTO territory.
The ischemic threshold is defined as:
• >12.5% of ischemia;
• With <50% transmural extent of infarction.
4. Subject agrees to undergo follow-up SPECT at 6 months after initial inclusion
5. Subject is able to verbally confirm understanding and he/she provides
written informed consent prior to any Clinical Investigation related procedure,
as approved by the appropriate Ethics Committee.
Exclusion criteria
• Subject is younger than 18 years of age;
• Persistent or permanent atrial fibrillation;
• Presence of a non-MRI compatible cardiac device, i.e. pacemaker or
implantable cardioverter defibrillator;
• Body weight > 250 kg;
• Unable to exert, i.e. due to physical disability;
• Any contraindication for SPECT or CMR, i.e. cerebrovascular clips,
claustrophobia;
• Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <60
mL/min/1.73m2 or serum creatinine level of >2.5 mg/dL or subject on dialysis);
• Hypersensitivity or allergy to contrast with inability to properly
pre-hydrate;
• Presence of a comorbid condition with a life expectancy of less than one year;
• Participation in another trial;
• Subject is belonging to a vulnerable population (per investigator*s judgment,
e.g., subordinate hospital staff) or is unable to read or write.
Design
Recruitment
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 |
|---|---|
| CCMO | NL67186.018.18 |