Registry on Left Main Coronary Artery Bifurcation Percutaneous Intervention

Overview

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.

Full Title of Study: “Web-based Registry on Left Main From the Euro Bifurcation Club (WE REMAIN EBC)”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2021

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Major adverse cardiac events (MACE)
    • Time Frame: 12 months
    • The composite of: death from any cause, myocardial infarction (MI), stent thrombosis (ST), defined as definite, probable or possible following the Academic Research Consortium.

Secondary Measures

  • Death
    • Time Frame: 12 months
    • All-cause death and cardiovascular death
  • MI
    • Time Frame: 12 months
    • Myocardial Infarction
  • ST
    • Time Frame: 12 months
    • Stent thrombosis (definite, probable or possible)
  • In-hospital MACE
    • Time Frame: 12 Months
    • Composite of death, MI and ST
  • Target Vessel Revascularization (TVR)
    • Time Frame: 12 Months
    • Target Vessel Revascularization
  • Bleeding
    • Time Frame: 12 Months
    • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • G. d’Annunzio University
  • Collaborator
    • Azienda Sanitaria Locale n. 2 – Lanciano Vasto Chieti
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marco Zimarino, MD, PhD – G. d’Annunzio University
  • Overall Official(s)
    • Marco Zimarino, MD, PhD, Principal Investigator, Azienda Sanitaria Locale n. 2 – Lanciano Vasto Chieti
  • Overall Contact(s)
    • Marco Zimarino, MD, PhD, +39 3476045261, m.zimarino@unich.it

References

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.

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.

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.

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