Registry on Left Main Coronary Artery Bifurcation Percutaneous Intervention

NCT04321473 | Unknown

• 1 other identifier: WE_REMAIN_EBC_19
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Arteriosclerosis; Left Main Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Death

  12 months

• MI

  12 months

• ST

  12 months

• In-hospital MACE

  12 Months

• Target Vessel Revascularization (TVR)

  12 Months

Interventions

PCI on left main PROCEDURE

PCI on left main coronary stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Related Publications (3)

• 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.

  PMID: 30528620 BACKGROUND

• 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.

  PMID: 27173860 BACKGROUND

• 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.

  PMID: 30165437 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Marco Zimarino, MD, PhD

  Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Zimarino, MD, PhD

CONTACT

+39 3476045261; m.zimarino@unich.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: September 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 Months