Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04878133 |
| Other study ID # |
OCT - 001621 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
January 31, 2025 |
Study information
| Verified date |
May 2021 |
| Source |
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven
by high risk criteria of plaques evaluated with OCT
Description:
In patients with ST segment elevation myocardial infarction (STEMI), percutaneous coronary
intervention (PCI) of the culprit lesion significally reduces the risk of cardiovascular
death. How to manage in this setting non-culprit lesion in patients with multivessel disease
still remain a matter of debate. Recently, the COMPLETE trial showed that complete PCI of
every coronary stenosis > 70% (or 50-69% lesions with FFR < 0.8) reduces risk of myocardial
infarction (MI) and unstable angina (UA) at 3 years compared with culprit-lesion PCI [1].
Whether this findings are related to revascularization of every obstructive lesions rather
than lesions with vulnerable-plaque characteristics, still remain unclear.
In high risk patients such as STEMI patients, physiopathology of coronary plaque deeply
differs from stable angina, mainly due to peculiar features of plaque. STEMI lesions, when
evaluated at autopsy or at intracoronary imaging, showed a pro-thrombotic pattern, with high
prevalence of thin cap fibro-atheroma, plaque rupture or thrombus, and a larger amount of
lipids and macrophage [2-6]. In this setting, angiography, even when combined with fractional
flow reserve evaluation (which can describe more accurately the functional impact of the
plaque), has intrinsic limitations because of lack of information about plaque
characteristics [7,8].
Optical coherence tomography (OCT) is the latest development in intravascular coronary
imaging. Similarly to intravascular ultrasound (IVUS), OCT provides cross-sectional images of
the vessel. However, instead of sound, OCT employs light for tissue analysis that enables
visualization of the coronary lesions with almost microscopic precision [9,10].
This tool can find high risk vulnerable plaque without angiographic or functional signs of
severity, helping from misdiagnosing and under-treating these lesions, that could benefit
from PCI even more than obstructive lesions without vulnerable plaque characteristics.
In an OCT substudy of the COMPLETE trial, researchers determined that half of patients had
obstructive nonculprit lesions with vulnerable plaque, which could explain why complete
revascularization conferred better outcomes than culprit lesion-only revascularization in the
main trial. This substudy pointed out also a 20% of non-obstructive non-culprit lesions with
vulnerable plaque caracteristics and up to 30% of obstructive non-culprit lesions without
high risk morphology [11]. It suggest that a morphological approach to PCI in high risk
patients can provide a more specific treatment compared with standard angiographic/functional
approach. A correct identification of coronary plaque instability in a setting of STEMI
patients could deeply impact in these patients risk of cardiovascular events, angina and re-
hospitalization.
Being coronary artery disease a pandemic disease with an important impact on nations health
care, a reduction in events in these patients do not impact only on patients quality of life,
but on health care system resources.
Consequently, we propose a randomized controlled trial to evaluate the effective benefit of
OCT guided vs complete PCI in STEMI patients with multivessels coronary artery disease.
