To determine the effect of the stenting of intermediate, vulnerable coronary lesions on the prevention of future ACS, in patients with residual non-obstructive CAD after PCI for myocardial infarction.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a composite of major adverse cardiovascular events (all cause mortality,
non-fatal myocardial infarction (STEMI or NSTEMI), or unplanned
revascularization) at one year follow-up.
Secondary outcome
The primary outcome at 2 and 5 year follow up
Background summary
Recently, major advances in the treatment of acute coronary syndromes have been
made, but still there is a large proportion of patients at risk for new
coronary events after experiencing ACS. In addition to medical treatment,
detection of residual vulnerable plaques after ACS and local treatment by means
of coronary intervention can further reduce adverse cardiac events in this
group of unstable patients.
Study objective
To determine the effect of the stenting of intermediate, vulnerable coronary
lesions on the prevention of future ACS, in patients with residual
non-obstructive CAD after PCI for myocardial infarction.
Study design
This is a multi center, randomized clinical trial. After PCI for myocardial
infarction patients with residual, hemodynamically non-obstructive plaque will
be analysed for vulnerability by means of CCTA (optional) and OCT. Patients
with vulnerable coronary segments on OCT wil be randomized to biovascular
scaffold (BVS) placement or medical treatment.
Intervention
After inclusion, patients will undergo coronary CT (optional) and OCT to
determine if the residual stenose is vulnerable. In case of vulnerable plaques
on OCT patients will be randomized to PCI with BVS placement or to conservative
(optimal medical) therapy.
Study burden and risks
Patients included in the trial will undergo coronary CTA, unless there are
logistical or clinical issues hindering the use of CTA. If CTA shows features
of plaque vulnerability or if CTA is not performed, patients will undergo FFR.
After FFR (if there is a hemodynamically important stenosis, patients will
undergo PCI according to the guidelines), OCT will be performed to confirm
plaque vulnerability. If this is the case, half of these patients will undergo
PCI with BVS placement. Thus patients will be admitted to the hospital for 1-2
days and exposed to radiation (CTA and ICA), the risks of intracoronary imaging
and possibly to PCI. Extra bloodsamples will be taken after informed consent
and when patients are randomised to intervention extra bloodsamples will be
taken after PCI. Patients will be followed by telephonic follow-up at 1, 2 and
5 years for 10 minutes. Furthermore, the first 25 randomized patients will be
followed by telephonic contact after 30 days (±7 days). Risk/benefit: expected
benefit is a reduction in major adverse cardiac events, at the cost of an
expected low amount of procedure related complications.
de Boelelaan 1118
Amsterdam 1081 HV
NL
de Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- patients with acute myocardial infarction and residual, non-obstructive CAD, with the possibility of plaque vulnerability.
- the coronary lesion must be suitable for PCI with a commercially available BVS.
Exclusion criteria
- Refusal or inability to provide informed consent.
- < 18 years of age
- Previous CABG.
- Indication for revascularization by CABG.
- Target vessel diameter < 2,5 mm or >4.0 mm
- Anatomy or lesions unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications)
- Anatomy unsuitable for BVS placement (left main, bifurcation stenting, sidebranch (> 2 mm) involvement).
- Target lesion is instent restenosis
- Target lesion is chronic total occlusion
- Severe kidney disease defined as an eGFR < 30 ml/min.
- Target lesion in the same vessel as the treated culprit lesion
- Target lesion in the same segment as a previously implanted stent/scaffold
- Estimated life expectancy < 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL55011.029.15 |
| OMON | NL-OMON26010 |