Registry on Left Main Coronary Artery Bifurcation Percutaneous Intervention

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

Interventions

PROCEDURE

PCI on left main

PCI on left main coronary stenosis

Sponsors & Collaborators

• Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• VZW Cardiovascular Research Center Aalst

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Clinica Mediterranea

  collaborator OTHER

• Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Instituto Dante Pazzanese de Cardiologia

  collaborator OTHER

• University Medical Centre Maribor

  collaborator OTHER

• Clinica Di Montevergine

  collaborator OTHER

• Clinical Hospital Centre Zagreb

  collaborator OTHER

• Clinical Centre of Serbia

  collaborator OTHER

• Chiba University

  collaborator OTHER

• Université Paris-Sud

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Mount Sinai Hospital, New York

  collaborator OTHER

• Hospital Pablo Tobón Uribe

  collaborator OTHER

• Pauls Stradins Clinical University Hospital

  collaborator OTHER

• University Hospital Monastir, Tunis

  collaborator OTHER

• G. d'Annunzio University

  lead OTHER

Principal Investigators

• Marco Zimarino, MD, PhD · Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-04-30

Completion

2021-09-30