Fractional FLOw Reserve In Cardiovascular DiseAses (FLORIDA)

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Status: Completed

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Treatments: Procedure: Angiography-only; Procedure: Fractional flow reserve

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04597489

VF/1021/1084

Details and patient eligibility

About

The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world cohort.

Full description

The objective of the FLORIDA study was to investigate mortality outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world patient cohort, including patients with different stages of coronary artery disease as well as patients with acute coronary syndrome (ACS). All patients were followed for a period of 3 years after the index date. The analysis period extended from the individual index date to the date of death or the end of the 3-year follow-up period. Patients were matched for sex, presence of acute coronary syndrome, age ± 5 years, and propensity scores estimated with logistic regression based on 72 variables , with each FFR patient matched to the closest angiography-only patient

Enrollment: 64,045 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015.

Exclusion criteria

• Loss to follow-up of other reasons than death (i.e. change of insurance)

Trial design

64,045 participants in 6 patient groups

Angiography + FFR

Description:

Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.

Treatment:

Procedure: Fractional flow reserve

Angiography only

Description:

Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.

Treatment:

Procedure: Angiography-only

Subgroup ACS

Description:

Patients were stratified by index diagnoses, i.e. acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) according to the index hospital admission diagnosis. This subgroup consists of patients presenting with ACS.

Treatment:

Procedure: Fractional flow reserve

Procedure: Angiography-only

Subgroup CCS

Description:

Patients were stratified by index diagnoses, i.e. acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) according to the index hospital admission diagnosis. This subgroup consists of patients presenting with CCS.

Treatment:

Procedure: Fractional flow reserve

Procedure: Angiography-only

Subgroup revascularization

Description:

Patients were stratified by the type of treatment, i.e. percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or conservative management with optimal medical therapy (OMT) alone, based on the procedure codes during the index hospital stay. This subgroup consists of patients undergoing revascularization after an angiography (with or without FFR) during the index hospital stay.

Treatment:

Procedure: Fractional flow reserve

Procedure: Angiography-only

Subgroup optimal medical therapy

Description:

Patients were stratified by the type of treatment, i.e. percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or conservative management with optimal medical therapy (OMT) alone, based on the procedure codes during the index hospital stay. This subgroup consists of patients undergoing optimal medical therapy after an angiography (with or without FFR) during the index hospital stay.

Treatment:

Procedure: Fractional flow reserve

Procedure: Angiography-only