Coronary Artery Disease in Elderly People Referred for TAVI (CEPTAVI)

University Hospital Center (CHU)

Status: Unknown

Conditions: Coronary Ang; Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT04930510

RECHMPL21_0208

Details and patient eligibility

About

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

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

170 participants in 2 patient groups

Group 1 : Elderly 80 years or over patients referred for TAVI with CAD

Description:

Elderly 80 years or over patients referred for TAVI with CAD Group 1: Coronary lesion defined as significant (\>50% narrowing) on the coronary angiography performed before TAVI, with or without PCI (decision of the heart team) Description of the coronary lesions included: proximal/non proximal, number of lesions, location of lesion

Group 2 : No significant coronary disease group

Description:

No significant coronary disease group in the cohort of elderly 80 years or over referred for TAVI