Clinical trial NCT03079739: Long-term Outcome of Deferred Lesion Based on FFR
Official title: The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 1305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with established or suspected ischemic heart disease referred for coronary artery angiography in which at least 1 lesion is evaluated by FFR.

Brief summary: Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices. The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.

Detailed description: Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices.

The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.

All centers capable of performing FFR were invited to participate and there were no predefined exclusion criteria, other than the patient's unwillingness to provide written informed consent.

The decision to perform FFR was left to the operator in each case. The study primary purpose was to evaluate, in the routine daily practice, the long-term clinical outcome of coronary lesions where the treatment was deferred based on FFR result.

An independent corelab will review all angiograms to perform quantitative coronary analysis, calculation of syntax score, residual syntax score, functional syntax score and, in ACS patients, discrimination between culprit and non culprit lesions An indipendent committee will assess and adjudicate all adverse events.

Eligibility criteria: Inclusion Criteria:

* written consent
* age \>18 years
* FFR assessment in at least one coronary lesion

Exclusion Criteria:

* life expectancy \<1 year because of known noncardiovascular comorbidity
* unwillingness to provide written informed consent

Primary outcomes:
measure: target vessel failure
timeFrame: 1 year
Secondary outcomes:
measure: target vessel failure
timeFrame: 3 years
measure: target vessel failure
timeFrame: 5 years
Other outcomes:
Locations:
city: Mercogliano
country: Italy
facility: Clinica Montevergine SPA
state: Avellino
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
city: Paderno Dugnano
country: Italy
facility: Clinica San Carlo
state: Milano
city: Brescia
country: Italy
facility: Istituto Clinico Sant'Anna
city: Como
country: Italy
facility: Ospedale Valduce
city: Milano
country: Italy
facility: Clinica Sant'Ambrogio
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
city: Sassari
country: Italy
facility: AOU di Sassari
Study officials:
References: