Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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 :
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 :
Analysis associated of the computerized patient record.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : Elderly 80 years or over patients referred for TAVI with CAD | 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 | No significant coronary disease group in the cohort of elderly 80 years or over referred for TAVI |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Patients aged of 80 years or over who are admitted in cardiology for TAVI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence Leclercq, PU PH | Contact | 4.67.33.67.33 | 33 | f-leclercq@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florence Leclercq, PU PH | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uhmontpellier | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29928311 | Background | 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. | |
| 33824628 | Background | 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. |
Not provided
Not provided
NC
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Rate of ischaemic | ischaemic event (acute coronary syndrome, severe angina) | 1 year |
| 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 |
| Re-hospitalization for cardiac events | Re-hospitalization for cardiac events | 1 year |
| 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 |
| D014694 |
| Ventricular Outflow Obstruction |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |