Fractional FLOw Reserve In Cardiovascular DiseAses (FLORIDA)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Procedure: Fractional flow reserve; Procedure: Angiography-only

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 Type: Observational
• Enrollment (Actual): 64045

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70469
    • LinkCare GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Out of a dataset of 4,395,540 anonymized age- and sex-stratified people from an anonymized German health claims database, patients undergoing at least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015 were included in the analysis. The discharge date of the first hospital stay involving a coronary angiography was defined as the patient's individual index date. Patients were included into the study population regardless of their underlying disease (all-comers approach), if they were observable for at least four years (one year prior the time of inclusion and three years after the time of inclusion), or died within follow-up.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Prospectively assessed at a quarterly basis.	12 months
All-cause mortality	Prospectively assessed at a quarterly basis.	24 months

Collaborators and Investigators

• Sponsor: LinkCare GmbH
• Collaborators: Charite University, Berlin, Germany; Abbott; Ruhr University of Bochum; University Hospital Schleswig-Holstein; University Hospital, Zürich
• Investigators: Study Chair: Tobias Vogelmann, MSc, LinkCare GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: VF/1021/1084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No