Left main coronary artery stenosis Circulatory System Atherosclerotic heart disease
Conditions
Interventions
Current hypothesis as of 04/11/2020:
Left Main SCORE trial is a national, multicenter, randomized clinical trial whose objective is to compare two myocardial revascularization strategies in patients w
Sponsors
Comité de Ética de Investigación con medicamentos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/12/2020: 1. Aged >18 years 2. cheduled for myocardial revascularization and eligible to be treated with CABG or PCI due to left main trunk disease (LMD) or equivalent ± other coronary lesions 3. SYNTAX score of 22 or less 4. Able to sign the informed consent 5. Capable of complying with medical treatment after the procedure 6. Able to comply with the follow-up for 5 years _____ Previous 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
Exclusion criteria
Exclusion criteria: Current inclusion criteria as of 04/12/2020: 1. SYNTAX score >22 2. Myocardial Infarction with ST elevation of less than 24 h of evolution 3. Cardiogenic shock 4. Requiring emergent myocardial revascularization: less than 6 h 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 40 kg/m2 2. Myocardial Infarction with ST elevation of less than 24 h of evolution 3. Cardiogenic shock 4. Requiring emergent myocardial revascularization: less than 6 h 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 10. Allergy to aspirin or P2Y12 receptor inhibitors. 11. Allergy to medications associated with the drug eluting stent. 12. Inability to sign informed consent. 13. Patients unable to comply with post-procedure medical treatment. 14. Patients unable to be followed up for at least 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 07/12/2020: Primary outcomes will be recorded in patient medical records at 1 month, 6 months and 12 months. The present protocol leaves open the possibility to extend the follow-up to 5 years, depending on financial support. 1. Incidence of repeated revascularization 2. Combined incidence of global mortality, stroke, myocardial infarction related to the procedure, myocardial infarction unrelated to the procedure, repeated revascularization ('MACCE' events) _____ Previous primary outcome measures: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/12/2020: Secondary outcomes will be recorded in patient medical records at 1 month, 6 months and 12 months. The present protocol leaves open the possibility to extend the follow-up to 5 years, depending on financial support. 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 _____ Previous 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 | — |
Countries
Spain
Outcome results
None listed