title: SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation.
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.
  
  
  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.
authors.affiliation: Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italy. Electronic address: geko50@hotmail.com.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Stabile
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Pucciarelli
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Linda
authors.initials: L
authors.lastname: Cota
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Sorropago
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Tullio
authors.initials: T
authors.lastname: Tesorio
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Salemme
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Grigore
authors.initials: G
authors.lastname: Popusoi
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Ambrosini
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Cioppa
authors.affiliation: Coronary Care Unit, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Agrusta
authors.affiliation: Intensive Care Unit, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Donato
authors.initials: D
authors.lastname: Catapano
authors.affiliation: Intensive Care Unit, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Moscariello
authors.affiliation: Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Trimarco
authors.affiliation: Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Esposito
authors.affiliation: Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods* / Q000401:mortality; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors
keywords: Bleedings; DAPT; TAVI; Vascular complications