Coronary Artery Disease, Left Main Coronary Artery Disease, Left Main Coronary Artery Stenosis, Restenosis, Coronary
Conditions
Keywords
Left Main Coronary Artery, Intermediate Coronary Lesions, iFR, Coronary Physiology, IVUS
Brief summary
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
Detailed description
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients who could benefit from revascularization. Studies with a limited number of patients have shown that a value of FFR above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the validation of the prognostic power of this index in patients with intermediate LMCA lesions has not been demonstrated, although it is used in clinical practice assuming the results in other locations of the lesions. The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
Interventions
OTHERIndication of revascularization
Device: iFR/FFR
Sponsors
Fundación EPIC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR. * Patients aged ≥18 years. * Patients able of giving informed consent.
Exclusion criteria
* Patients with indication for coronary surgery regardless of the significance of the LMCA lesion. * Patients with a LMCA lesion presenting with ulceration, dissection or thrombus. * Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected). * Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA. * Patients unable to obtain informed consent. * Patients with known terminal illness that conditions a life expectancy less than 1 year. * Patients with hemodynamic instability with Killip III or IV class.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events | 30 days | Composite of death, myocardial infarction, unplanned revascularisation |
| Assessment correlation between FFR>=0.80 and iFR >=0.89 | 1 day | Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions of the LMCA with a cut-off point to defer the treatment of FFR\> = 0.80 (with intravenous adenosine) and iFR \> = 0.89. the LMCA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death (cardiovascular) | 30 days, 1 and 5 years | Death (cardiovascular) |
| Non-fatal Myocardial Infarction | 30 days, 1 and 5 years | Non-fatal Myocardial Infarction |
| Non-fatal Myocardial Infarction related to the LMCA lesion | 30 days, 1 and 5 years | Non-fatal Myocardial Infarction related to the LMCA lesion |
| Revascularization | 30 days, 1 and 5 years | Revascularization |
| Assessment correlation between iFR and IVUS | 5 years | Assessment correlation between iFR and IVUS derived minimal luminal area |
| Myocardial Infarction related to target lesion revascularization | 30 days, 1 and 5 years | Myocardial Infarction related to target lesion revascularization |
| Stent Thrombosis in the target lesion revascularization | 30 days, 1 and 5 years | Stent Thrombosis in the target lesion revascularization |
| Restenosis of the stent in target lesion | 30 days, 1 and 5 years | Restenosis of the stent in target lesion |
| New revascularization of the target lesion | 30 days, 1 and 5 years | New revascularization of the target lesion |
| Revascularization of the target lesion | 30 days, 1 and 5 years | Revascularization of the target lesion |
| Death (all cause) | 30 days, 1 and 5 years | Death (all cause) |
Countries
Spain
Outcome results
None listed