Fractional FLOw Reserve In Cardiovascular DiseAses

NCT04597489 | Completed

• 1 other identifier: VF/1021/1084
• Study Type: observational
• Target: 64,045
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• All-cause mortality

  12 months

• All-cause mortality

  24 months

Study Arms (6)

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

Angiography only

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

Procedure: Angiography-only

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; Procedure: Angiography-only

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; Procedure: Angiography-only

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; Procedure: Angiography-only

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; Procedure: Angiography-only

Interventions

Fractional flow reserve PROCEDURE

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

Also known as: FFR

Angiography + FFR; Subgroup ACS; Subgroup CCS; Subgroup optimal medical therapy; Subgroup revascularization

Angiography-only PROCEDURE

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

Angiography only; Subgroup ACS; Subgroup CCS; Subgroup optimal medical therapy; Subgroup revascularization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• LinkCare GmbH: lead
• Abbott: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital, Zürich: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Ruhr University of Bochum: collaborator

Study Sites (1)

LinkCare GmbH

Stuttgart, 70469, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Tobias Vogelmann, MSc

  LinkCare GmbH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2019
• Primary Completion: January 20, 2020
• Study Completion: March 2, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)