Fractional FLOw Reserve In Cardiovascular DiseAses

Study Overview
=================
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

Official Title
-----------------
Fractional FLOw Reserve In Cardiovascular DiseAses

Conditions
-----------------
Coronary Artery Disease, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Procedure: Fractional flow reserve
* Procedure: Angiography-only


Participation Criteria
=================
Eligibility Criteria
-----------------
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)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Angiography + FFR<br>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<br>* Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.<br>* Other names: FFR;|
| Angiography only<br>Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed. | Procedure: Angiography-only<br>* Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.<br>|
| Subgroup ACS<br>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<br>* Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.<br>* Other names: FFR;Procedure: Angiography-only<br>* Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.<br>|
| Subgroup CCS<br>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<br>* Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.<br>* Other names: FFR;Procedure: Angiography-only<br>* Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.<br>|
| Subgroup revascularization<br>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<br>* Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.<br>* Other names: FFR;Procedure: Angiography-only<br>* Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.<br>|
| Subgroup optimal medical therapy<br>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<br>* Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.<br>* Other names: FFR;Procedure: Angiography-only<br>* Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.<br>|

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 |