Coronary Arteriosclerosis Clinical Trial
Official title:
Web-based Registry on Left Main From the Euro Bifurcation Club (WE REMAIN EBC)
The slowly accruing evidence on the treatment of patients with left main coronary artery
(LMCA) disease drove evolution in guidelines, that currently establish equivalent safety and
efficacy for percutaneous coronary intervention (PCI) as compared to surgery, with a class of
recommendation that is subjected to the extension and complexity of concomitant coronary
artery disease, as assessed by the SYNTAX score.
The severity of LMCA disease, although extremely relevant due to the extent of the supplied
myocardium, is often difficult to assess with traditional angiography, due to lack of
appropriate angiographic views, absence of a true "reference" segment, interaction with the
intubating catheter. Intravascular techniques with either imaging or functional assessment
have been variously tested, although with a disturbing rate of discordant results; moreover,
they are frequently underused for a number of reasons, including the additional time needed
to assess both left anterior descending (LAD) and left circumflex (LCx) arteries, technical
challenges, costs and the small risk associated with maneuvering such devices. Fractional
flow reserve (FFR) measured from the coronary angiogram (FFRangio) alone recently documented
a high diagnostic accuracy compared with pressure-wire derived FFR.
As for the anatomical localization, the majority of LMCA lesions occur at the bifurcation,
where PCI results are less favourable. The distal LMCA differs from the other bifurcations in
several characteristics: a) a notable mismatch between the LMCA and the left anterior
descending (LAD) artery, hampering the selection of an adequately sized stent, b) the
presence of a trifurcation, with a large ramus arising from LMCA in about 10% of cases, c)
the presence of left or co-dominant circulation, with the LMCA supplying all or nearly all
left ventricular myocardium in about 15% of cases.
Therefore, although the European Bifurcation Club (EBC) recommends a provisional side branch
approach in most cases of distal LMCA disease, the threshold for placing a second stent in
the side branch may be lower in lesions located on LM bifurcation compared with non-LMCA
bifurcations. As for double stenting, the evidence is controversial and a consensus is
lacking. Moreover, the optimal treatment of patients with LM trifurcations is still
undefined.
The aim of this study is therefore to determine the optimal strategy for the treatment of LM
bifurcated lesions.
PCI access site and technique will be left at the operator's discretion, as well as
antithrombotic management.
No limitation will be applied for the technique of PCI. As regards data collection and
endpoints, Case Report Form (CRF) will be entered on a web-based platform, where study
participants will be able to access and retrieve data at any time during study progress.
In-hospital outcomes will be recorded; all patients discharged alive will be followed up with
a 30-day, 6-month, and 1-year telephone interview.
On a center-to-center voluntary basis, pre-PCI and post-PCI angiographic images (made blind
regarding patients' identity) will be sent to a study angiographic core-lab for Quantitative
Angiography Substudy. The images will be processed using a validated quantitative coronary
angiography (QCA) Bifurcation software to assess quantitative data describing bifurcation
geometry before and after LMCA PCI. In the Quantitative Angiography Substudy, on exploratory
bases, FFRangio data reconstructed by angiographic software will be tested against stenosis
LMCA lesion severity and LMCA PCI result.
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