Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities

NCT04663334 | Completed DMC

• 1 other identifier: AP001
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis. Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its prognostic impact is not clearly established, and available studies uncommonly used functional assessment of severity from a coronary stenosis to stratify the risk in this situation. Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous coronary intervention (PCI) in clinical practice. Its use is not validated in patients with severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After aortic valvular replacement, a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment. The aim of the study is to assess the effects of inverse myocardial remodeling on coronary microcirculatory function and its association with FFR values before and after TAVI.

Conditions

Severe Symptomatic Aortic Stenosis

Keywords

Coronary Flow Reserve; Index of Microvascular Resistance; Fractional Flow Reserve; Transcatheter Aortic Valve Implantation; Coronary Artery Disease; Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Study the change in FFR values before and 6 months after TAVI

  FFR values are presented as median and interquartile range. FFR values comparisons pre-TAVI, post-TAVI, and 6 month after procedure.

  6 months

Interventions

inverse myocardial remodeling OTHER

a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment

Eligibility Criteria

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

Study Population

All patients have severe symptomatic aortic stenosis, secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient \>40 mmHg and/or valve area \<1 cm2) and significant epicardial coronary stenosis (\> or = 50%) assessed by coronarography performed in systematic preoperative work-up. These patients are deemed for TAVI and a first-line medical treatment for CAD, after heart team decision.

You may qualify if:

• Adults older than 18 years. For female of childbearing age, active contraceptive method is recommended.
• patients with severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient \>40 mmHg and/or valve area \<1 cm2) and with significant coronary artery disease (epicardial coronary stenosis angiography \> or = to 50%)

You may not qualify if:

• Severe CAD with tritroncular lesions or severe stenosis (\>90 %) of left main artery or proximal left anterior descending artery
• Lack of viability in myocardial territory of interest
• History of bypass coronary surgery or heart transplantation
• Severe left ventricular systolic dysfunction, characterized by an ejection fraction \< 35 %
• Severe renal impairment (Creatinine clearance \<30 ml/min/1.73 m2)
• Absolute contraindication to intravenous adenosin
• Pregnant or nursing women Patients under guardianship, curatorship, or protection of justice

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, 44000, France

Location

Related Publications (1)

• Battistolo Q, Le Ruz R, Piriou PG, Guerin P, Letocart V, Plessis J, Poinas A, Senage T, Manigold T. Changes in microcirculation following transcatheter aortic valve implantation in patients with stable coronary artery disease. Arch Cardiovasc Dis. 2025 Apr;118(4):222-230. doi: 10.1016/j.acvd.2024.12.006. Epub 2024 Dec 21.

  PMID: 39827054 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 Officials

• Thierry Manigold

  Nantes University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: December 8, 2020
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

FR (1)