Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

N/AActive Not RecruitingNCT03767621

Fundación EPIC300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Coronary Artery Disease Left Main Coronary Artery Stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (38)

Hospital Universitari Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital General Universitario de Santa Lucia de Cartagena

Cartagena, Murcia, Spain

Hospital Clinico Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain

Hospital General Universitario de Castellón

Castellon, Valencia, Spain

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, Spain

Outcomes

Primary Outcomes

Assessment correlation between FFR>=0.80 and iFR >=0.89

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.

Time frame: 1 day

Major Adverse Cardiac Events

Composite of death, myocardial infarction, unplanned revascularisation

Time frame: 30 days

Major Adverse Cardiac Events

Composite of death, myocardial infarction, unplanned revascularisation

Time frame: 1 year

Major Adverse Cardiac Events

Composite of death, myocardial infarction, unplanned revascularisation

Time frame: 5 years

Secondary Outcomes

Assessment correlation between iFR and IVUS

Assessment correlation between iFR and IVUS derived minimal luminal area

Time frame: 5 years

Death (all cause)