Left Main Coronary Artery Stenosis
Conditions
Keywords
IVUS, PCI, Left Main, QCA, Treatment Strategy
Brief summary
The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided Percutaneous Coronary Intervention (PCI). Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure for the last enrolled patient. Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and yearly after (outpatient clinic visit or telephone call).
Interventions
DEVICEIVUS guided Percutaneous Coronary Intervention
Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
DEVICEQualitative or quantitative angiography will guide percutaneous coronary intervention
Qualitative or quantitative angiography will be used to determine lesion characteristics
Sponsors
ECRI bv
Philips Healthcare
Boston Scientific Corporation
Cardialysis B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient must be ≥ 18 years of age; 2. De novo lesion in an unprotected left main coronary artery (ULMCA; ostial, shaft or distal) OR ostial left anterior descending artery (LAD) or ostial circumflex (LCX), both compatible with one Medina class of LM disease; or ostial intermediate branch disease; 3. PCI is considered appropriate and feasible by the treating interventionalist; 4. Silent ischemia, stable angina, unstable angina, or non-ST segment elevation MI; 5. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years. Note: A patient with a prior CABG with no patent bypass on the left main coronary artery (LMCA) can be included.
Exclusion criteria
1. Patient is a woman who is pregnant or nursing; 2. Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause); 3. IVUS is strictly required for pre-PCI lesion severity assessment 4. ST-elevation myocardial infarction, cardiogenic shock; 5. Previous history of CABG with patent graft to the LAD and/or patent graft to the LCX; 6. Prior PCI of the LM, ostial LAD or ostial LCX at any time prior to enrollment; 7. Prior PCI of any other (i.e. non-LM, non-ostial-LAD and non-ostial-LCX) coronary artery lesions within 30 days prior to enrollment; 8. Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients; 9. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants. 10. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post-enrollment; 11. Non-cardiac co-morbidities with a life expectancy less than 2 years; 12. Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study for at least 12 months after enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented Composite Endpoint (POCE) | 2-5 years follow up | Patient-oriented Composite Endpoint (PoCE): composite of all-cause death, any stroke, any myocardial infarction (MI)\*, any clinically indicated revascularization at longest follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented Composite Endpoint (DoCE) | 2-5 years follow up | Device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel MI, clinically indicated repeat revascularization of the target lesion at longest follow-up |
| Vessel-oriented Composite Endpoint (VoCE) | 2-5 years follow up | Vessel-oriented Composite Endpoint (VoCE) defined as the composite of: left main related cardiac death, target vessel MI, clinically indicated -repeat revascularization of the left main vessels at longest follow-up. |
| Patient-oriented Composite Endpoint (POCE) | 2 year follow up | Patient-oriented Composite Endpoint (PoCE): composite of all-cause death, any stroke, any myocardial infarction (MI)\*, any clinically indicated revascularization at 2 years follow-up. |
| All individual components of PoCE at all time points. | 2-5 years follow-up | All individual components of PoCE at all time points. |
| All individual components of DoCE at all time points. | 2-5 years follow-up | All individual components of DoCE at all time points. |
| Definite and probable stent thrombosis | 2-5 years follow-up | Definite and probable stent thrombosis according to ARC definition |
| Hospitalization for heart failure | 2-5 years follow-up | Investigator reported hospitalization for heart failure |
Countries
Italy, Spain, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORAdrian Banning, Prof
Oxford University Hospitals NHS Trust
PRINCIPAL_INVESTIGATORLuca Testa, Dr.
Policlinco San Donato
Outcome results
None listed