Functional Assessment in TAVI: FAITAVI

NCT03360591 | Active Not Recruiting

• 1 other identifier: FAITAVI
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies:

1. 1.the Angiographically-guided strategy;
2. 2.the Physiologically-guided strategy.

Conditions

Coronary Artery Disease; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Incidence of the treatment

  Composite of all-cause death, myocardial infarction, stroke, major bleeding, need for target vessel revascularization as adjudicated by the Clinical Event Committee

  12 months

Secondary Outcomes (1)

• Safety endpoint

  30 days

Study Arms (2)

Physiologically-guided strategy

EXPERIMENTAL

Patients randomized in this group will undergo stenting of coronary lesions showing FFR values ≤0.80 only. * Lesions showing positive FFR measurements (\<0.80) must be treated with PCI, before or after TAVI. * Lesions showing clearly negative values (FFR \>0.80) will not be treated with PCI before TAVI, and repeated FFR and iFR measurements after TAVI are strongly recommended. * Lesions showing "borderline" FFR measurements before TAVI (FFR 0.80-0.83), should be measured again (both FFR and iFR) after TAVI, and the decision of treating of deferring treatment in a given lesion will be based on the FFR value obtained after TAVI. * In all cases iFR values will be recorded for a post hoc analysis and for validation of the study endpoints according to iFR values.

Device: Physiologically-guided strategy

Angiographically-guided strategy

OTHER

Patients allocated in this group will undergo stenting of all coronary stenosis ≥50% as assessed by visual estimation in vessels ≥2.5mm. PCI can be performed before in a previous procedure, or after TAVI, but always within one month, ± 5 days of the valve implantation.PCI in the group randomized to the angio-guided procedure can be performed therefore, either before or after valve implantation, in the same or in different procedures. Implantation of second-generation drug eluting stents (DES) in all interventions is advised, but not mandatory, and the brand of the stent is left to the operators and center's choice.

Device: Physiologically-guided strategy

Interventions

Physiologically-guided strategy DEVICE

The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches \>2.5mm, with a % coronary stenosis\>50% as evaluated by visual estimation. The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR \>0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, and using the same study end-points. Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values \>0.80 that show a discrepancy with positive (\<0.89) iFR values to investigate the reliability of the FFR in the aortic stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy

Also known as: Angiographically-guided strategy

Angiographically-guided strategy; Physiologically-guided strategy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Written informed consent
• Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team
• Diagnosis of at least one coronary stenosis \>50% at angiography
• No specific pharmacologic treatment is required to enter the study

You may not qualify if:

• Age \< 18 years
• Pregnancy
• Lack of informed consent
• Impaired left ventricular function
• Signs or symptoms of acute (unstable) myocardial ischemia
• Contraindication to adenosine administration (e.g., asthma, chronic obstructive pulmonary disease, heart rate \<50 beats/min, and systolic blood pressure \<90 mmHg)
• Reduced survival expectancy due to severe co-morbidities (\<1 year)
• Impossibility to obtain follow-up information

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

Related Publications (2)

• Ribichini FL, Scarsini R, Pesarini G, Fabris T, Barbierato M, D'Amico G, Zanchettin C, Gregori D, Lorenzoni G, Piva T, Nicolini E, Gandolfo C, La Spina K, Fineschi M, Gallo F, Baccani B, Petronio AS, De Carlo M, Berti S, Drago A, Saia F, Sclafani R, Esposito G, D'Ascenzo F, Tarantini G; FAITAVI Trial investigators. Physiology vs angiography-guided percutaneous coronary intervention in transcatheter aortic valve implantation: the FAITAVI trial. Eur Heart J. 2025 Dec 19:ehaf974. doi: 10.1093/eurheartj/ehaf974. Online ahead of print.

  PMID: 41417623 DERIVED

• Ribichini F, Pesarini G, Fabris T, Lunardi M, Barbierato M, D'Amico G, Zanchettin C, Gregori D, Piva T, Nicolini E, Gandolfo C, Fineschi M, Petronio AS, Berti S, Caprioglio F, Saia F, Sclafani R, Esposito G, D'Ascenzo F, Tarantini G. A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial. EuroIntervention. 2024 Apr 15;20(8):e504-e510. doi: 10.4244/EIJ-D-23-00679.

  PMID: 38629420 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: November 24, 2017
• Primary Completion: June 30, 2024
• Study Completion: June 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)