1. SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation.
- Author
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Stabile E, Pucciarelli A, Cota L, Sorropago G, Tesorio T, Salemme L, Popusoi G, Ambrosini V, Cioppa A, Agrusta M, Catapano D, Moscariello C, Trimarco B, Esposito G, and Rubino P
- Subjects
- Aged, Aged, 80 and over, Aortic Valve Stenosis mortality, Cardiac Catheterization mortality, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Pilot Projects, Transcatheter Aortic Valve Replacement mortality, Treatment Outcome, Aortic Valve Stenosis drug therapy, Aortic Valve Stenosis surgery, Cardiac Catheterization methods, Platelet Aggregation Inhibitors administration & dosage, Transcatheter Aortic Valve Replacement methods
- Abstract
Background: Common clinical practice recommends dual antiplatelet therapy (DAPT) for transcatheter aortic valve implantation (TAVI). The aim of the study was to evaluate, in a double blind randomized study, the safety of TAVI, with adjunctive pharmacotherapy consisting of single antiplatelet therapy., Methods and Results: From April 2010 to April 2011, 120 consecutive patients, undergoing TAVI, have been enrolled in the study. Patients were randomly assigned to DAPT group (aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid) or ASA group (aspirin only). TAVI device was the Sapien XT-Novaflex Delivery System (Edwards Lifesciences, Inc.). All patients were followed up to 6 months. Device success was achieved in 100% of patients. No difference in the VARC combined 30 day safety endpoint, all cause and cardiovascular mortality was observed. At 30 days vascular complications were reduced in the ASA group (p<0.05). No differences in the clinical status were detected between the groups up to 6 months., Conclusions: This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality. These findings, if confirmed in a larger multicenter randomized trial, will no longer support the use of DAPT for TAVI., (Copyright © 2014. Published by Elsevier Ireland Ltd.)
- Published
- 2014
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