Condition category
Circulatory System
Date applied
19/10/2019
Date assigned
22/10/2019
Last edited
22/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The narrowing of the coronary arteries (also called 'coronary heart disease') causes chest pain (angina), heart attacks, and heart failure.

Left main disease is the blockage of the left main coronary artery. This study aims to compare two treatments: coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with the use of a drug-releasing stent.

A coronary artery bypass graft (CABG) is a surgical procedure used to treat coronary heart disease. It diverts blood around narrowed or clogged parts of the major arteries to improve blood flow and oxygen supply to the heart.

A coronary angioplasty (also known as percutaneous coronary intervention) is a procedure used to widen blocked or narrowed coronary arteries (the main blood vessels supplying the heart). Angioplasty means using a balloon to stretch open a narrowed or blocked artery. However, most modern angioplasty procedures also involve inserting a short wire-mesh tube, called a stent, into the artery during the procedure. The stent is left in place permanently to allow blood to flow more freely

Who can participate?
Patients aged 18-80 who are due to have coronary artery surgery

What does the study involve?
Participants will be randomised to receive one of the two treatments described above

What are the possible benefits and risks of participating?
Patients participating of the trial will be benefited from a close follow up which will last one year. Since this trial will test standard revascularization procedures, participating patients will no suffer from any additional risk compared with those submitted to revascularization procedure out of the present trial

Where is the study run from?
Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain

When is the study starting and how long is it expected to run for?
November 2019 to November 2022

Who is funding the study?
Fundación Canaria de Investigación y Salud (Canary Islands Foundation for Health and Research)

Who is the main contact?
Dr Stefano Urso
stefano_urso@inwind.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefano Urso

ORCID ID

http://orcid.org/0000-0002-7239-3195

Contact details

Hospital Universitario Dr. Negrín
Cirugía Cardíaca
Calle Plaza Barranco de la Ballena
Las Palmas
35010
Spain
+34928450000
stefano_urso@inwind.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

44731574R

Study information

Scientific title

Left Main Spanish COronary REvascularization trial

Acronym

LM-SCORE

Study hypothesis

Patients with left main disease treated percutaneously have a significantly higher repeat revascularization events compared to patients who undergo coronary artery bypass grafting with bilateral internal mammary artery

Ethics approval

Approval pending, Ethics Committee of Hospital Universitario Dr. Negrín, Las Palmas De Gran Canaria, Spain.

Study design

National multicenter randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Left main disease

Intervention

Left Main SCORE trial is a national, multicenter, randomized clinical trial whose objective is to compare two myocardial revascularization strategies in patients with left main disease (LMD): coronary artery bypass grafting (CABG) with the use of bilateral mammary artery versus percutaneous coronary intervention (PCI) with the use of a second-generation drug-eluting stent (everolimus). The present clinical trial will have a 1-year clinical follow-up.

Randomization will be carried out by a randomization software in permutated blocks by Hospital with stratification by diabetes (present/absent). Treatment allocation based on random software-generated sequences will be blind to analyzers.

Patients with left main disease will be randomized, according to random software-generated sequences, in two groups: coronary artery bypass grafting (CABG) with the use of bilateral mammary artery (Control) and percutaneous coronary intervention (PCI) with the use of a second-generation drug-eluting stent (Intervention)

Intervention type

Device

Phase

Not Applicable

Drug names

Everolimus

Primary outcome measure

1. Incidence of repeated revascularization
2. Composed incidence of global mortality, stroke, myocardial infarction related to the procedure, myocardial infarction unrelated to the procedure, repeated revascularization (“MACCE” events) (time frames of 1 month, 6 months, 12 months).

Secondary outcome measures

Incidence of each of the following individual variables (time frames of 1 month, 6 months, 12 months):
1. Overall mortality
2. Cardiac death
3. Myocardial infarction related to the procedure
4. Myocardial infarction unrelated to the procedure
5. Revascularization of the target lesion
6. Revascularization of the coronary segment other than the target lesion
7. Revascularization of the left main stem (LMS)
8. Stroke
9. Stent thrombosis and symptomatic graft occlusion
10. Angina according to the Canadian Cardiovascular Society (CCS) classification
11. Functional class according to NYHA classification
12. Health cost assessment

Overall trial start date

01/11/2017

Overall trial end date

15/11/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 18 - 80 years
2. Scheduled for myocardial revascularization and susceptible to being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for left main stem disease (LMSD) or LMS equivalent ± additional significant coronary lesions diagnosed by coronary angiography. The LMSD will be defined as ≥ 50% stenosis documented by angiographic visual estimation or as a fractional flow reserve <0.80. The LMSD will be represented by the following Medina classification patterns: 1,1,1-1,0,1-1,1,0. The LMS equivalent will be defined by the presence of a disease (classified as 0,1,1) of ostial left anterior descendant artery and ostial circumflex artery producing a ≥ 70% stenosis by angiographic visual estimation or with a fractional flow reserve <0.80. Coronary lesions that do not affect the trunk will be considered susceptible to revascularization when they will affect a coronary artery with a diameter ≥ 1.5 mm and when they will produce a ≥ 70% stenosis documented by angiographic visual estimation, or when they will present a reserve of fractional flow <0.80
3. SYNTAX score of 32 or less
4. Possibility of signing the informed consent
5. Capable of complying with post-procedure medical treatment
6. Able to be followed up for a year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

330

Participant exclusion criteria

1. Body mass index > 40
2. Myocardial Infarction with ST elevation of less than 24 hours of evolution
3. Cardiogenic shock
4. Requiring emergent myocardial revascularization: less than 6 hours from the diagnosis of left main disease until the revascularization procedure
5. Unfavorable anatomy for PCI: additional calcified or severe tortuous coronary lesions
6. The presence of specific characteristics of the coronary lesion or clinical conditions that lead the interventional cardiologist or participating cardiac surgeon to believe that the clinical equipoise between PCI and CABG is not present
7. Need for any concomitant cardiac surgery other than isolated aorto-coronary bypass.
8. Previous cardiac surgery
9. Expected survival < 1 year
• Allergy to aspirin or P2Y12 receptor inhibitors.
• Allergy to medications associated with the drug eluting stent.
• Inability to sign informed consent.
• Patients unable to comply with post-procedure medical treatment.
• Patients unable to be followed up for at least one year.

Recruitment start date

15/11/2019

Recruitment end date

15/11/2021

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario Dr. Negrín
Calle Plaza Barranco de la Ballena
Las Palmas de Gran Canaria
35010
Spain

Trial participating centre

Hospital Universitario Insular
Calle Francisco Hernández González, 1
Las Palmas
35016
Spain

Trial participating centre

Complejo Hospitalario de Navarra
Calle de Irunlarrea, 3
Pamplona
31008
Spain

Trial participating centre

Hospital Universitario Germans Trias i Pujol
Carretera de Canyet
Badalona, Barcelona
08916
Spain

Trial participating centre

Hospital Virgen de la Salud
Av. de Barber, 30
Toledo
45004
Spain

Sponsor information

Organisation

Comité de Ética de Investigación con medicamentos

Sponsor details

Calle Plaza Barranco de la Ballena
Las Palmas
35010
Spain
+34 928450969
ceimprovlpa.scs@gobiernodecanarias.org

Sponsor type

Research council

Website

https://www.funcanis.org/index.php/enlaces

Funders

Funder type

Charity

Funder name

Fundación Canaria de Investigación y Salud

Alternative name(s)

Canary Islands Foundation for Health and Research, Canary Foundation and Health Research, FUNCIS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Spain

Results and Publications

Publication and dissemination plan

Once the statistical analysis will be finished (expected date: November 2022), the results of the study will be presented at the Congress of the Spanish Society of Thoracic-Cardiovascular Surgery, the Spanish Society of Cardiology and the Congress of the European Society of Cardiothoracic Surgery. Articles obtained by the statistical analysis of 1-year repeat revascularization and Major Adverse Cardiac Events (MACE) rates of the study population and those obtained from subgroup analyses will be sent for publication to international scientific journals: European Heart Journal, Circulation, Revista Española de Cardiología, European journal of Cardiothoracic surgery (expected date of publication of first report November 2023).

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

15/11/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/10/2019: Trial’s existence confirmed by Fundación Canaria de Investigación y Salud (FIISC)