Short Versus Long Antiplatelet Therapy After TAVI

Launched by UNIVERSITY HOSPITAL, CAEN · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how long patients should take aspirin after a procedure called Transcatheter Aortic Valve Replacement (TAVI), which is used to treat a heart condition known as aortic stenosis. The study is comparing two different approaches: one group will take aspirin for just 3 months, while another group will take it for a full year. The main goal is to find out if taking aspirin for a shorter time can help reduce the risk of bleeding without increasing the chances of serious heart problems.

To be eligible for this trial, participants need to be at least 18 years old and have successfully undergone TAVI for aortic stenosis. Participants will be contacted several times over the year following their procedure to report any bleeding or heart-related issues they may experience. It's important to note that certain conditions may exclude someone from participating, such as having other health issues that require long-term aspirin or blood-thinning medications. This study aims to ensure that patients receive the safest and most effective treatment after their heart procedure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18
• • Male or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female
• • Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33
• • Successful access, delivery of the device, and retrieval of the delivery system
• • Correct positioning of a single prosthetic heart valve into the proper anatomical location
• • Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related, or cardiac structural complication
• • Written informed consent
• • Social security affiliated
• • French speaking
• Exclusion Criteria:
• • Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI3
• • Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches
• • TAVI for other indications than aortic stenosis (pure aortic regurgitation)
• • Valve in valve TAVI
• • Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease...) at any time prior to randomization
• • Any indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus...) at any time prior to randomization
• • Patients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI
• • Any contraindication to long term antiplatelet therapy (e.g. allergy or intolerance to aspirin, major bleeding, high bleeding risk, thrombocytopenia \< 50 000, major haemostasis disorder...)
• • Women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy-
• • Adult with protective measures (tutorship, curatorship)
• * Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:
• • Patients with known or discovered severe cognitive impairment
• • Patients with treated or untreated severe psychological or psychiatric conditions
• • Patients with uncorrected severe hearing or visual handicap
• • Patients with addictive alcohol, drug or substance abuse
• • Patients with protective measures (guardianship, tutorship, curatorship)
• • Any other condition considered by the investigators as not warranting informed consent