Aortic Stenosis Clinical Trial
Official title:
Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI
Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)
- Background: TAVI has emerged as an alternative to surgical aortic valve replacement for
patients with severe, symptomatic aortic stenosis (AS) and is expanding worldwide with
more than 50,000 patients treated to date.
- Purpose Changes in haemostasis, particularly in platelet activation or reactivity
before, during and after TAVI have never been studied. Valve replacement is known to
alleviate von Willebrand factor abnormalities associated with AS. A potential
improvement of platelet function could also occur after TAVI. Indeed, circulating
platelets may be desensitized and under-reactive due to multiple passages through the
stenotic valve and could recover normal reactivity after TAVI. Besides, TAVI presents a
risk of major ischemic complications. The investigators can hypothesize the involvement
of high reactive platelets in peri-procedural thrombotic or ischemic events. This study
of the platelet activation kinetics will be performed by comparing several specific
markers before and at various times after valve implantation.
- Primary outcome To evaluate the kinetics of platelet activation before and at various
times after valve implantation, by comparing several specific markers in peripheral
venous blood samples before (day 0) and at days 1 and 5±1 after the procedure.
- Study design and number of subjects: This is a prospective, monocentric, study. The
test group includes up to 15 patients treated by transfemoral TAVI using a MedTronic
CoreValve (MCV) prosthesis. Platelet activation will be studied before and after the
procedure and compared to a reference established with an age-matched, aspirin-treated,
atherosclerotic population (30 patients in the control group).
- Eligibility criteria:
- inclusion criteria: test group: patients with severe aortic stenosis and
transfemoral TAVI with MCV aspirin treatment . Control group: age-matched patients
with stable coronary artery disease treated by aspirin but without aortic
stenosis.
- exclusion criteria: recent (1 month) acute coronary syndrome; treatment by anti
platelet agents other than aspirin
- Procedures: Specific platelet activation markers, circulating platelet/monocytes
aggregates, platelet reactivity and vWF will be assessed in peripheral venous blood
before, 1 and 5 days after TAVI and in ascending aorta during the procedure.
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