Registry on Left Main Coronary Artery Bifurcation Percutaneous Intervention

Coronary Arteriosclerosis Clinical Trial

— WE REMAIN EBC  

Official title:

Web-based Registry on Left Main From the Euro Bifurcation Club (WE REMAIN EBC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04321473
• Other study ID #: WE_REMAIN_EBC_19
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2020
• Source: G. d'Annunzio University
• Contact: Marco Zimarino, MD, PhD
• Phone: +39 3476045261
• Email: m.zimarino[@]unich.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: September 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Left Main Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• PCI on left main
PCI on left main coronary stenosis

Locations

Country	Name	City	State
n/a

Sponsors (21)

Lead Sponsor

Collaborator

G. d'Annunzio University

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, Chiba University, Clinica Di Montevergine, Clinica Mediterranea, Clinical Centre of Serbia, Clinical Hospital Centre Zagreb, Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Hospital Clínico Universitario de Valladolid, Hospital Pablo Tobón Uribe, Hospital Universitario Reina Sofia de Cordoba, Instituto Dante Pazzanese de Cardiologia, Mount Sinai Hospital, New York, Pauls Stradins Clinical University Hospital, San Raffaele University Hospital, Italy, Université Paris-Sud, University Hospital Monastir, Tunis, University Medical Centre Maribor, VZW Cardiovascular Research Center Aalst

References & Publications (3)

Lassen JF, Holm NR, Banning A, Burzotta F, Lefèvre 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. Review. — View Citation

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACE)	The composite of: death from any cause, myocardial infarction (MI), stent thrombosis (ST), defined as definite, probable or possible following the Academic Research Consortium.	12 months
Secondary	Death	All-cause death and cardiovascular death	12 months
Secondary	MI	Myocardial Infarction	12 months
Secondary	ST	Stent thrombosis (definite, probable or possible)	12 months
Secondary	In-hospital MACE	Composite of death, MI and ST	12 Months
Secondary	Target Vessel Revascularization (TVR)	Target Vessel Revascularization	12 Months
Secondary	Bleeding	The occurrence of major bleeding, as a bleeding defined by the academic research consortium (BARC)- classified as type 3 (a, b or c) or 5 bleeding event	12 Months

External Links

•   Web CRF Platform