Short versus long antiplatelet therapy after TAVI

INTERVENTION: Product Name: KARDEGIC 75 mg, poudre pour solution buvable en sachet‐dose,Product Code: PRD432444,Pharmaceutical Form: ORAL SOLUTION,Other descriptive name: ,Strength: D,L‐Lysine Acetylsalicylate 135mg,Product Name: ASPIRINE PROTECT 100 mg, comprimé gastro‐resistant,Product Code: PRD855689,Pharmaceutical Form: GASTRO‐RESISTANT TABLET,Other descriptive name: ,Strength: Acetylsalicylic Acid 100mg CONDITION: All adult patients with successful transfemoral trans‐aortic valve implantation (TAVI ) for symptomatic aortic stenosis (AS) with no other indication for long term antiplatelet or anticoagulant therapy ; MedDRA version: 20.1Level: LLTClassification code: 10041974Term: Stenosis aortic valveSystem Organ Class: 10007541 MedDRA version: 20.1Level: LLTClassification code: 10041974Term: Stenosis aortic valveSystem Organ Class: 10007541 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective:Non‐inferiority of the experimental arm (3 months therapy with 75 to 100 mg oral aspirin) compared to standard arm (12 months therapy with 75 to 100 mg oral aspirin) on a composite clinical event at 12 months follow‐up Primary end point(s):Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non‐procedure‐related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI Secondary Objective:Superiority of the experimental arm in reducing all bleeding events,Superiority of the experimental arm in reducing clinically significant, major or disabling bleeding,Non inferiority of the experimental arm on the composite of major cardiovascular events,Comparison of individual components of composite end points and other secondary outcomes between the two arms,To assess the cost utility and the cost effectiveness of short versus long antiplatelet therapy,Mortality at 2 years follow‐up assessed virtually on the national mortality database INCLUSION CRITERIA: • Age = 18,• Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC‐33 o Successful access, delivery of the device, and retrieval of the delivery system o Correct positioning of a single prosthetic heart valve into the proper anatomical location o 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,• 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 SECONDARY OUTCOME: Secondary end point(s):• Any hospitalization Secondary end point(s):• Any non‐procedure‐related bleeding defined by the VARC classification 1 to 4 Secondary end point(s):• Cardiovascular death Secondary end point(s):• Cardiovascular hospitalization Secondary end point(s):• Death Secondary end point(s):• Death at 2 years (national mortality database) Secondary end point(s):• Evaluation of costs using the French national health database (SNDS) Secondary end point(s):• Evaluation of the Quality of life using EQ‐5D‐5L scale at randomization and M12. Secondary end point(s):• Fatal bleeding defined by Type 4 VARC classification Secondary end point(s):• Incremental cost‐efficacy ratio for major bleeding events Secondary end point(s):• Incremental cost‐utility ratio Secondary end point(s):• Intracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury Secondary end point(s):• Major cardiovascular events defined by the composite of all cause death, myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury Secondary end point(s):• Major or disabling or life threatening bleeding defined by VARC classification 2 or 3 Secondary end point(s):• Stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury Secondary end point(s):• Transient cerebral ischemic attack defined by NeuroARC type 3a Secondary end point(s):• Type 1 myocardial infarction based on the universal definition Secondary end point(s):• Type 1 VARC classification bleeding Secondary end point(s):• Type 2 VARC classification bleeding Secondary end point(s):• Type 3 VARC classification bleeding Secondary end point(s):• VARC‐3 defined Cardiovascular hospitalization Secondary end point(s):• VARC‐defined prosthetic valve thrombosis