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

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Acute coronary syndromes (ACS) (n=1258). Intervention: Fractional flow reserve (FFR)-guided treatment vs. Angiography-guided treatment. Primary outcome: All-cause mortality at 3 years (27% relative risk reduction, p=0.04).

Q: What does this research mean for the field?

In unselected patients with acute coronary syndrome, fractional flow reserve-guided revascularization is associated with a 27% relative risk reduction in 3-year all-cause mortality compared to angiography-guided revascularization. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Teresa Gerhardt; Barbara E. Stähli; Tanja K. Rudolph; Matthias Lutz; Anne-Sophie Schatz; Lukas Zanders; T. Schubert; Magnus Stueve; Nick E.J. West; Els Boone; Ulf Landmesser; David M. Leistner

doi:10.1007/s00380-023-02256-7

April 17, 2023Heart and VesselsOpen Access

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

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Key result

Fractional flow reserve-guided revascularization was associated with a 27% relative risk reduction in 3-year all-cause mortality compared to angiography-guided treatment in patients with ACS.

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Why the study?

The long-term prognostic value of fractional flow reserve measurement in unselected all-comer ACS patients remains unknown.

Does an FFR-guided treatment strategy reduce all-cause mortality in unselected all-comer patients with acute coronary syndromes compared to an angiography-guided strategy?

Key Points

To evaluate the long-term prognostic impact of fractional flow reserve (FFR)-guided versus angiography-guided lesion management in an unselected, real-world cohort of patients with acute coronary syndrome.
Analyzed an unselected, population-based matched cohort from the German FLORIDA study using the InGef Research Database for patients presenting with acute coronary syndromes who underwent coronary angiography between January 2014 and December 2015.
Categorized patients into FFR-guided or angiography-guided revascularization strategies and monitored them over a 3-year follow-up period for all-cause mortality (primary endpoint) and major adverse cardiovascular events (secondary endpoint).
All-cause mortality at 3 years was significantly lower in the FFR-guided group than in the angiography-guided group (10.2% vs. 14.0%, p = 0.04), representing a 27% relative risk reduction.
Rates of major adverse cardiovascular events at 3 years were comparable between the FFR-guided and angiography-guided arms (47.7% vs. 51.5%, p = 0.14), with similar rates of non-fatal myocardial infarction (27.7% vs. 25.4%, p = 0.47) and repeat revascularization (9.9% vs. 12.1%, p = 0.17).

Study Design

Type

Cohort (n=1,258)

Multicenter

Yes

Structured PICO

Does an FFR-guided treatment strategy reduce all-cause mortality in unselected all-comer patients with acute coronary syndromes compared to an angiography-guided strategy?

P

Population

1,258 matched patients with acute coronary syndromes undergoing coronary angiography, followed for 3 years.

E

Exposure

Fractional flow reserve (FFR)-guided treatment strategy for the management of lesions

C

Comparator

Angiography-guided treatment strategy

O

Outcome

All-cause mortality at 3 yearshard clinical

Main Result

Effect estimate: 27% relative risk reduction

Absolute Event Rate: 10.2% vs 14%

Number Needed to Treat: 27

p-value: p=0.04

Limitations

Information on angiographic lesion severity and single or multivessel disease was not available in the database.
Identification of specific ACS types (unstable angina, NSTEMI, and STEMI) was precluded.
Distinction between FFR measurements performed during the index procedure and those performed during staged procedures was not possible.
Unable to differentiate between cardiac and non-cardiac death as cause of death was not collected.
Elective staged procedures may have been misclassified as events of repeated revascularization.
Lack of information on educational level, socio-demographic status, and lifestyle factors (e.g., smoking, physical activity).
Possibility of misclassification and miscoding of data inherent to health claims databases.

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Implication

FFR-guided revascularization in an unselected, real-world cohort of ACS patients was associated with significantly lower 3-year all-cause mortality compared to angiography guidance.

Abstract

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.

Discussion

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Cite This Study

Gerhardt et al. (2023) conducted a cohort in Acute coronary syndromes (ACS) (n=1,258). Fractional flow reserve (FFR)-guided treatment vs. Angiography-guided treatment was evaluated on All-cause mortality at 3 years (27% relative risk reduction, p=0.04). Fractional flow reserve-guided revascularization was associated with a 27% relative risk reduction in 3-year all-cause mortality compared to angiography-guided treatment in patients with ACS.

synapsesocial.com/papers/6aad09eb69162e2e3b24bff1 https://doi.org/10.1007/s00380-023-02256-7

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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