Clinical trial NCT05698719: Validation of vFFR as Compared to FFR to Guide Revascularization of Non-culprit Lesions in STEMI Patients
Official title: Validation of Angiography-based FFR as Compared to Pressure Wire-based FFR to Guide Revascularization of Intermediate Coronary Lesions in Non-culprit Vessels in Patients Presenting With ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST Elevation Myocardial Infarction
Multivessel Coronary Artery Disease
Percutaneous Coronary Intervention
Keywords: Pressure wire-based coronary physiology (FFR, RFR, dPR)
Angiography-based coronary physiology (vFFR)
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.

Brief summary: This prospective multicenter observational cohort study is designed to study the diagnostic performance of acute-setting angiography-based FFR (e.g. vFFR) for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting FFR and acute-setting NHPR (e.g. RFR) as the reference standards.

Detailed description: The FAST STEMI II study is an investigator-initiated, multicenter, single-arm, observational cohort study aiming to include 111 patients presenting with ST-elevation myocardial infarction (STEMI). The study is designed to assess the diagnostic performance of acute-setting angiography-based fractional flow reserve (e.g. vessel fractional flow reserve (vFFR)) for the physiological assessment of intermediate non-culprit lesions, with acute-setting fractional flow reserve (FFR) and acute-setting non-hyperemic pressure ratio (NHPR) (e.g. resting full-cycle ratio (RFR)) as the reference standards.

Angiography-based FFR has the potential to guide complete revascularization in STEMI patients with multivessel disease, thereby reducing the need for invasive pressure wires and hyperemic agents. However, dedicated data regarding the diagnostic performance of acute-setting angiography-based FFR, with acute-setting FFR and NHPR as the reference standards, is currently lacking for this subset of patients.

Of note, FFR slightly underestimates the hemodynamic significance of non-culprit lesions in the acute setting due to microvascular constriction and a blunted hyperemic response, while NHPR slightly overestimates the functional lesion significance. Angiography-based fractional flow reserve is not affected by changes in the microvasculature. Potential discrepancies between acute-setting angiography-based FFR, FFR and NHPR might be explained by the microvascular state, expressed as coronary flow reserve (CFR) and the index of microvascular resistance (IMR).

Main objectives:

1. To study the diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting FFR as the reference standard.
2. To study the diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting RFR as the reference standards.
3. To study the impact of CFR and IMR on the potential discrepancies between acute-setting vFFR, FFR and RFR.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* At least one intermediate non-culprit lesion (50-90% diameter stenosis by visual estimation or online QCA) in a non-infarct related artery (reference vessel diameter \>2.00 mm) for which invasive pressure wire-based physiological assessment is deemed feasible and indicated.

Exclusion Criteria:

* Presentation with cardiac arrest or cardiogenic shock.
* Previous coronary artery bypass graft surgery or percutaneous coronary intervention involving the non-culprit vessel.
* Ostial left main or ostial right coronary artery lesion.
* Excessive overlap, foreshortening or tortuosity precluding vFFR computation.

Primary outcomes:
measure: The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR as the reference standard.
timeFrame: Intraprocedural (0 days)
Secondary outcomes:
measure: The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting RFR as the reference standard.
timeFrame: Intraprocedural (0 days)
measure: The diagnostic performance of acute-setting RFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR as the reference standard.
timeFrame: Intraprocedural (0 days)
measure: The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.
timeFrame: Postprocedural (max. 7 days)
measure: The diagnostic performance of offline vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR and RFR as the reference standards.
timeFrame: Postprocedural (max. 7 days)
measure: The diagnostic performance of offline vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.
timeFrame: Postprocedural (max. 7 days)
measure: The correlation between CFR and the potential discrepancies between acute-setting vFFR, FFR and RFR.
timeFrame: Intraprocedural (0 days)
measure: The correlation between IMR and the potential discrepancies between acute-setting vFFR, FFR and RFR.
timeFrame: Intraprocedural (0 days)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Erasmus Medical Center
name: Joost Daemen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: