Clinical trial NCT04321473: Registry on Left Main Coronary Artery Bifurcation Percutaneous Intervention
Official title: Web-based Registry on Left Main From the Euro Bifurcation Club (WE REMAIN EBC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Arteriosclerosis
Left Main Coronary Artery Disease
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
name: Hospital Clínico Universitario de Valladolid
name: VZW Cardiovascular Research Center Aalst
name: Federico II University
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Clinica Mediterranea
name: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
name: San Raffaele University Hospital, Italy
name: Instituto Dante Pazzanese de Cardiologia
name: University Medical Centre Maribor
name: Clinica Di Montevergine
name: Clinical Hospital Centre Zagreb
name: Clinical Centre of Serbia
name: Chiba University
name: Université Paris-Sud
name: Hospital Universitario Reina Sofia de Cordoba
name: Mount Sinai Hospital, New York
name: Hospital Pablo Tobón Uribe
name: Pauls Stradins Clinical University Hospital
name: University Hospital Monastir, Tunis
First posted: 2020-03-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of documented silent ischemia, stable angina, or ACS, undergoing PCI with single or multiple DES for the treatment of lesion located at LM coronary bifurcation and defined as a diameter stenosis of ≥50% by visual estimation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age with a diagnosis of documented silent ischemia, stable angina, or acute coronary syndrome (ACS).
* PCI with single or multiple drug-eluting stent (DES) for the treatment of lesion located at LMCA bifurcation and defined as a diameter stenosis of ≥50% by visual estimation.

Exclusion Criteria:

* Patients who cannot give informed consent or have a life expectancy of ≤12 months;
* Pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant.
* Contraindication or suspected intolerance to anticoagulant (heparin, bivalirudin) or oral antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor).

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Death
timeFrame: 12 months
measure: MI
timeFrame: 12 months
measure: ST
timeFrame: 12 months
measure: In-hospital MACE
timeFrame: 12 Months
measure: Target Vessel Revascularization (TVR)
timeFrame: 12 Months
measure: Bleeding
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
name: Marco Zimarino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimarino M, Briguori C, Amat-Santos IJ, Radico F, Barbato E, Chieffo A, Cirillo P, Costa RA, Erglis A, Gamra H, Gil RJ, Kanic V, Kedev SA, Maddestra N, Nakamura S, Pellicano M, Petrov I, Strozzi M, Tesorio T, Vukcevic V, De Caterina R, Stankovic G; EuroBifurcation Club. Mid-term outcomes after percutaneous interventions in coronary bifurcations. Int J Cardiol. 2019 May 15;283:78-83. doi: 10.1016/j.ijcard.2018.11.139. Epub 2018 Dec 2.
citation: Lassen JF, Holm NR, Banning A, Burzotta F, Lefevre T, Chieffo A, Hildick-Smith D, Louvard Y, Stankovic G. Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club. EuroIntervention. 2016 May 17;12(1):38-46. doi: 10.4244/EIJV12I1A7.
citation: Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.