SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation

Int J Cardiol. 2014 Jul 1;174(3):624-7. doi: 10.1016/j.ijcard.2014.04.170. Epub 2014 Apr 21.


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.

Keywords: Bleedings; DAPT; TAVI; Vascular complications.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / drug therapy*
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery*
  • Cardiac Catheterization / methods*
  • Cardiac Catheterization / mortality
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Pilot Projects
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Transcatheter Aortic Valve Replacement / methods*
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome


  • Platelet Aggregation Inhibitors