Clinical trial NCT04930510: Coronary Artery Disease in Elderly People Referred for TAVI
Official title: IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Coronary Ang
Keywords: Patients over 80 years
TAVI
coronary artery disease
quality of life
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 170
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged of 80 years or over who are admitted in cardiology for TAVI

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the incidence of major cardio-vascular event
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of CAD
timeFrame: 1 year
measure: Length of hospitalisation
timeFrame: 1 year
measure: Rate of ischaemic
timeFrame: 1 year
measure: Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)
timeFrame: 1 year
measure: Re-hospitalization for cardiac events
timeFrame: 1 year
measure: Quality of life with assessment of clinical status
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florence Leclercq, PU PH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Matta AG, Lhermusier T, Parada FC, Bouisset F, Canitrot R, Nader V, Blanco S, Elbaz M, Roncalli J, Carrie 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.