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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Charite University, Berlin, Germany | OTHER |
| University Hospital, Zürich | OTHER |
| University Hospital Schleswig-Holstein |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiography + FFR | Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization. |
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| Angiography only | Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Prospectively assessed at a quarterly basis. | 12 months |
| All-cause mortality | Prospectively assessed at a quarterly basis. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Vogelmann, MSc | LinkCare GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LinkCare GmbH | Stuttgart | 70469 | Germany |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053805 | Fractional Flow Reserve, Myocardial |
| ID | Term |
|---|---|
| D003326 | Coronary Circulation |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| OTHER |
| Ruhr University of Bochum | OTHER |
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| 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. |
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| Angiography-only | Procedure | Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed. |
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| 24 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |