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

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

Author information

1
Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italy. Electronic address: geko50@hotmail.com.
2
Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy.
3
Coronary Care Unit, Clinica Montevergine, Mercogliano, Italy.
4
Intensive Care Unit, Clinica Montevergine, Mercogliano, Italy.
5
Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italy.

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.

KEYWORDS:

Bleedings; DAPT; TAVI; Vascular complications

PMID:
24809922
DOI:
10.1016/j.ijcard.2014.04.170
[Indexed for MEDLINE]

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