Prognostic impact of fractional flow reserve measurements in patients with acute coronary syndromes: a subanalysis of the FLORIDA study.

Randomized trials suggest benefits for fractional flow reserve (FFR)-guided vs. angiography-guided treatment strategies in well-defined and selected patient cohorts with acute coronary syndromes (ACS). The long-term prognostic value of FFR measurement in unselected all-comer ACS patients, however, remains unknown. This subanalysis of the Fractional FLOw Reserve In cardiovascular DiseAses (FLORIDA) study sought to investigate the long-term effects of FFR in the management of lesions in patients with acute coronary syndrome (ACS). FLORIDA was an observational all-comer cohort study performed in Germany, that was population-based and unselected. Patients enrolled into the anonymized InGef Research Database presenting with ACS and undergoing coronary angiography between January 2014 and December 2015 were included in the analysis. Patients were stratified into either the FFR-guided or the angiography-guided treatment arm, based on the treatment received. A matched cohort study design was used. The primary endpoint was all-cause mortality. The secondary endpoint was major adverse cardiovascular events (MACE), a composite of death, non-fatal myocardial infarction (MI), and repeat revascularization. Follow-up time was 3 years. Rates of 3-year mortality were 10.2 and 14.0% in the FFR-guided and the angiography-guided treatment arms (p = 0.04), corresponding to a 27% relative risk reduction for FFR in ACS patients. Rates of MACE were similar in both arms (47.7 vs. 51.5%, p = 0.14), including similar rates of non-fatal MI (27.7 vs. 25.4%, p = 0.47) and revascularization (9.9 vs. 12.1%, p = 0.17). In this large, all-comer observational study of ACS patients, FFR-guided revascularization was associated with a lower mortality at 3 years. This finding encourages the routine use of FFR to guide lesion revascularization in patients presenting with ACS.

Fractional flow reserve measurements and long-term mortality-results from the FLORIDA study.

Background: Randomized evidence suggested improved outcomes in fractional flow reserve (FFR) guidance of coronary revascularization compared to medical therapy in well-defined patient cohorts. However, the impact of FFR-guided revascularization on long-term outcomes of unselected patients with chronic or acute coronary syndromes (ACS) is unknown. Aims: The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided vs. angiography-guided treatment strategies in a large, real-world cohort. Methods: This study included patients enrolled into the German InGef Research Database. Patients undergoing coronary angiography between January 2014 and December 2015 were included in the analysis. Eligible patients had at least one inpatient coronary angiogram for suspected coronary artery disease between January 2014 and December 2015. Patients were stratified into FFR arm if a coronary angiography with adjunctive FFR measurement was performed, otherwise into the angiography-only arm. Matching was applied to ensure a balanced distribution of baseline characteristics in the study cohort. Patients were followed for 3 years after index date and primary endpoint was all-cause mortality. Results: In the matched population, mortality at 3 years was 9.6% in the FFR-assessed group and 12.6% in the angiography-only group (p = 0.002), corresponding to a 24% relative risk reduction with use of FFR. This effect was most pronounced in patients in whom revascularization was deferred based on FFR (8.7% vs. 12.3%, p = 0.04) and in high-risk subgroups including patients aged ≥75 years (14.9% vs. 20.1%, p < 0.01) and those presenting with ACS (10.2% vs. 14.0%, p = 0.04). Conclusions: FFR-based revascularization strategy was associated with reduced mortality at 3 years. These findings further support the use of FFR in everyday clinical practice.

Health Technology Assessments for Flash Glucose Monitoring and How to Use Them in Everyday Clinical Practice.

BACKGROUND: Various health technology assessment (HTA) agencies review new medical devices worldwide, and their recommendations can be useful in guiding clinical decision making. However, different agencies use different processes and methodologies, resulting in variation in recommendations. OBJECTIVES: The objectives were to review full HTAs for a new technology for diabetes management, flash glucose monitoring (FGM), with the aim of summarizing similarities/differences in processes, methodologies, and recommendations from the perspective of everyday clinical practice. METHODS: A literature review was conducted using online HTA resources. RESULTS: Four full HTAs were identified (Canary Islands, France, Catalunya, and Norway); one issued a conditional recommendation for patients with type 1 diabetes mellitus (T1DM) with controlled glycated hemoglobin (HbA1c) (Spain; Canary Islands), one issued a broader recommendation for patients with T1DM and T2DM (France), and two reported that there was insufficient evidence to support a recommendation (Spain [Catalunya] and Norway). The most comprehensive and stringent of the available HTAs were those in the Canary Islands and Norway, which included systematic literature reviews (SLRs), consultation with patient groups and clinicians, GRADE evidence quality assessments, and full economic models. Comprehensive HTAs either did not recommend FGM (Norway) or restricted the recommendation to a small subpopulation of the overall diabetes population (Canary Islands). CONCLUSION: HTAs represent a valuable additional resource for clinicians to consider alongside clinical evidence, guidelines, and consensus papers; however, interpreting recommendations requires an understanding of the processes behind these recommendations. In this review, comprehensive HTAs either recommended for a selected subpopulation based on RCT evidence or found insufficient evidence for a recommendation.