The purpose of this study is to determine the incidence of major vascular events (ischemic or haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral anticoagulation or dual antiplatelet therapy) in both arms followed TAVI.
Transcatheter aortic valve implantation (TAVI) procedure using any of their vascular access is an option with proven benefit definitively for treatment of severe symptomatic aortic stenosis in patients considered unsuitable for conventional open heart surgery.
By avoiding the hemodynamic effects, cardiovascular and cerebral microembolic load of cardiopulmonary bypass circulation, it is assumed that the TAVI procedure is beneficial despite the risk of neurological complications. Currently antithrombotic therapy after the procedure is not standardized. International treatment guidelines recommends that post-operative patients with a conventional surgical aortic bioprosthesis maintain oral anticoagulation for 3 months after the procedure, unless otherwise noted for its continuation. Whereas some studies have postulated that in patients with aortic bioprostheses, dual antiplatelet therapy is as effective to prevent major cardiac and cerebrovascular events as oral anticoagulation, with a lower incidence of bleeding complications at 3 months of treatment, the investigators formulated the following hypothesis:
• There is a lower incidence of major cardiac and cerebrovascular events in patients with dual antiplatelet therapy compared to patients with oral anticoagulation for 3 months after implantation of an aortic bioprosthesis TAVI procedure.
- Aspirin+clopidogrel (Duoplavin) Drug
Other Names: DUOPLAVIN (aspirin 100 mg + clopidogrel 75 mg).; SINTROM (ACENOCUMAROL). Intervention Desc: 100 mg aspirin ;75 mg clopidogrel 3º months ARM 1: Kind: Experimental Label: Duoplavin Description: Both active substances in DuoPlavin: clopidogrel and acetylsalicylic acid, are inhibitors of platelet aggregation. Clopidogrel stops the platelets aggregating by blocking ADP. Acetylsalicylic acid the platelets aggregating by blocking the prostaglandin cyclo oxygenase. ARM 2: Kind: Experimental Label: acenocumarol
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Evaluate the effectiveness of dual antiplatelet therapy versus oral anticoagulation for prevention of cerebral thromboembolism by the detection of new areas of cerebral infarction by Magnetic Resonance Imaging (MRI) 3 months after TAVI.||3 months||Yes|
|Secondary||Determine the incidence of new areas of cerebral infarction by MRI between the different routes of vascular access and the various valve devices.||1 hour before TAVI, 1 hour and 24 hours after TAVI||Yes|
|Secondary||Identify the development of cognitive impairment after TAVI||Pre-TAVI, and at 1º 3º and 6º month after TAVI||Yes|
|Secondary||Evaluate the Quality of life after TAVI.||Pre-TAVI, and at 1º; 3º and 6º month after TAVI.||No|