Fractional FLOw Reserve In Cardiovascular DiseAses

Completed

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Interventions: Procedure: Angiography-only; Procedure: Fractional flow reserve

• Registration Number: NCT04597489
• Lead Sponsor: LinkCare GmbH

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-01-20
• Study Completion: 2020-03-02
• Status Verified: 2020-10
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64045

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Angiography only	Angiography-only	Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.
Subgroup ACS	Angiography-only	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.
Subgroup revascularization	Angiography-only	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.
Angiography + FFR	Fractional flow reserve	Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.
Subgroup CCS	Fractional flow reserve	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.
Subgroup CCS	Angiography-only	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.
Subgroup revascularization	Fractional flow reserve	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.
Subgroup optimal medical therapy	Fractional flow reserve	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.
Subgroup ACS	Fractional flow reserve	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.
Subgroup optimal medical therapy	Angiography-only	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.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	36 months	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. The primary endpoint was mortality at 3 years, prospectively assessed at a quarterly basis.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	24 months	Prospectively assessed at a quarterly basis.

Trial Locations

Locations (1)

LinkCare GmbH; 🇩🇪 Stuttgart, Germany