Coronary Artery Disease in Elderly People Referred for TAVI

Aortic Stenosis Clinical Trial

— CEPTAVI  

Official title:

IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930510
• Other study ID #: RECHMPL21_0208
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2021
• Source: University Hospital, Montpellier
• Contact: Florence Leclercq, PU PH
• Phone: 4.67.33.67.33
• Email: f-leclercq[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators prognostic impact of coronary artery disease (CAD) and of percutaneous coronary intervention (PCI) in patients with indication of TAVI is controversial, particularly in elderly population where CAD and aortic stenosis (AS) are frequent and commonly coexisted. (1-2) The primary end point of this prospective study is to compare major cardiovascular event at one year of follow up in patients over 80 years with severe aortic stenosis who referred for TAVI with or without associated CAD.

The investigators will also assess (secondary endpoint) the impact of PCI on symptoms, major events and quality of life using geriatric parameters. The study will be conducted in the University hospital of Montpellier between November 2020 and November 2022

Description:

Patients will be prospectively included in the study when aged of 80 years old or over and referred for TAVI at the university hospital of Montpellier.

Two groups of patients will be considered after coronary angiography which is systematic before TAVI Group 1: patients with significant > 50 % narrowing coronary stenosis ( revascularization by PCI / no revascularization) Group 2: No coronary lesion

Considering an end point at 1 year and a precision wished to i ± 6 percent with an alpha risk of 5 %, it's proposed , by the formula p= [(1.96)2 x [p(1-p)] / i2 ], a number of 170 subjects needed to highlight a incidence of major cardio-vascular event of 20 percent in the studied population.

Data collection by informatic files will include :

• Cardio vascular risk factor and medical history with evaluation of Charlston score

• Previous drug therapy

• Lifestyle : living alone or not, nursing home, ; home help

• Symptoms (angina (CSS classification) ; dyspnea (NHYA classification))

• Renal function (DFG) at admission

• Results of coronary angiography (number of lesions, proximal or non proximal, location of coronary stenosis)

• Geriatric assessment : autonomy, disability in daily living, weigh, BMI, falls, cognitive functions tests, assessment of the mood state by GDS

• Results of TAVI (success and complications of the procedure according to VARC2 criteria)

• Results of coronary revascularization if performed

• Length of hospitalisation for TAVI (days), length of stay in ICU (Intensive Care Unit) if necessary

• Events during the hospitalisation for TAVI (VARC and BARC criterias)

Follow up at 6 month (middle analysis) and at one year (primary end point) by phone conversation with the patient for assessment of :

• Major cardio-vascular events

• Hospitalisation occurred

• Short geriatric evaluation including :

• cognition by Ottawa3DY

• autonomy by ADL

• polypharmacy

• number of fall in the past 6 month

• last weight

• quality of life (Fried criterias)

• mood state by GDS If neurocognitive disorders are known or discovers, data patient's validity will be check by calling his caregiver and/or his general practitioner (if caregiver not available).

Analysis associated of the computerized patient record.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion criteria:

• patient aged 80 and over

• hospital admission for evaluation before TAVI indicated for symptomatic and severe aortic stenosis

• patient's consent

Exclusion criteria:

• absence of coronarography

• severe angina (class 3 or 4)

• stenosis of left main coronary artery > 50%

• stenosis of the left anterior descending artery > 90%

• decision of surgical valve replacement

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (2)

Cao D, Chiarito M, Pagnotta P, Reimers B, Stefanini GG. Coronary Revascularisation in Transcatheter Aortic Valve Implantation Candidates: Why, Who, When? Interv Cardiol. 2018 May;13(2):69-76. doi: 10.15420/icr.2018:2:2. Review. — View Citation

Matta AG, Lhermusier T, Parada FC, Bouisset F, Canitrot R, Nader V, Blanco S, Elbaz M, Roncalli J, Carrié D. Impact of Coronary Artery Disease and Percutaneous Coronary Intervention on Transcatheter Aortic Valve Implantation. J Interv Cardiol. 2021 Mar 24;2021:6672400. doi: 10.1155/2021/6672400. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the incidence of major cardio-vascular event	Comparison of the incidence of major cardio-vascular event at one year follow up in elderly 80 or over referred for TAVI with (group 1) or without CAD (group 2).; Major cardio vascular events evaluated at 1 year follow-up include: Death (total and cardiovascular); ischemic stroke,; haemorrhagic stroke,; acute coronary syndrome,; severe angina (> class 2),; major bleeding or vascular complications (>BARC2),; Re-hospitalisation for cardiac events	1 year
Secondary	Incidence of CAD	Incidence of CAD in the elderly over 80 years old during the pre TAVI evaluation Evaluate the coronary disease impact in the elderly over 80 referred for TAVI by the number of patients over 80 years with significant coronary lesions compared to global TAVI population over 80 years	1 year
Secondary	Length of hospitalisation	Length of hospitalisation with or without coronary disease, with or without PCI.; Length of hospitalisation in total and in the ICU if it's happened to evaluated the economic impact of CAD and therapeutic strategy.	1 year
Secondary	Rate of ischaemic	ischaemic event (acute coronary syndrome, severe angina)	1 year
Secondary	Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)	minor bleeding (BARC 1 and 2) and major (BARC 3 et 4) event or vascular complication (VARC 2).	1 year
Secondary	Re-hospitalization for cardiac events	Re-hospitalization for cardiac events	1 year
Secondary	Quality of life with assessment of clinical status	Quality of life with assessment of clinical status by geriatrics tests geriatrics tests by phone interview of the patient	1 year