Heart, Lung and Circulation

Transcatheter Aortic Valve Replacement and Atrial Fibrillation: Impact of Antithrombotic Strategy on Clinical Outcomes

Published:April 04, 2018DOI:


      Antithrombotic recommendations following transcatheter aortic valve replacement (TAVR) are largely based on previous trial protocols. The efficacy and risk of anticoagulation has not been systematically assessed. The aim of this study was to determine the efficacy and safety of oral anticoagulation in patients with atrial fibrillation (AF) following TAVR with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA).


      Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited (n = 164). Atrial fibrillation patients prescribed oral anticoagulation (standard AF therapy) were compared to non-AF patients prescribed aspirin and clopidogrel (standard non-AF therapy). Twenty (20) of 164 patients were excluded, as they were not prescribed standard therapy. The primary endpoint was 6-month incidence of death, myocardial infarction, stroke/transient ischaemic attack (TIA) or major/life-threatening bleeding. Secondary endpoints included each component of the primary endpoint, defined according to VARC-2.


      Overall, the primary endpoint occurred in 20.8% and 17.7% of the standard AF and standard non-AF therapy groups respectively (p = 0.82). There was no statistically significant difference in bleeding (12.5% versus 9.4%, p = 0.77) or stroke/TIA (2.1% versus 8.3%, p = 0.27) between the standard AF and standard non-AF therapy groups respectively.


      This study supports the safety of anticoagulation in AF patients, which did not result in excess risk of bleeding or stroke/TIA compared with dual antiplatelet therapy in non-AF patients.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Heart, Lung and Circulation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Daneault B.
        • Kirtane A.J.
        • Kodali S.K.
        • Williams M.R.
        • Genereux P.
        • Reiss G.R.
        • et al.
        Stroke associated with surgical and transcatheter treatment of aortic stenosis: a comprehensive review.
        J Am Coll Cardiol. 2011; 58: 2143-2150
        • Tarantini G.
        • Mojoli M.
        • Windecker S.
        • Wendler O.
        • Lefèvre T.
        • Saia F.
        • et al.
        Prevalence and impact of atrial fibrillation in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: an analysis from the SOURCE XT prospective multicenter registry.
        JACC Cardiovasc Interv. 2016; 9: 937-946
        • Leon M.B.
        • Smith C.R.
        • Mack M.
        • Miller D.C.
        • Moses J.W.
        • Svensson L.G.
        • et al.
        Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.
        N Engl J Med. 2010; 363: 1597-1607
        • Sannino A.
        • Stoler R.C.
        • Lima B.
        • Szerlip M.
        • Henry A.C.
        • Vallabhan R.
        • et al.
        Frequency of and prognostic significance of atrial fibrillation in patients undergoing transcatheter aortic valve implantation.
        Am J Cardiol. 2016; 118: 1527-1532
        • Otto C.M.
        • Kumbhani D.J.
        • Alexander K.P.
        • Calhoon J.H.
        • Desai M.Y.
        • Kaul S.
        • et al.
        2017 ACC expert consensus decision pathway for transcatheter aortic valve replacement in the management of adults with aortic stenosis: a report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents.
        J Am Coll Cardiol. 2017; 69: 1313-1346
        • Makkar R.R.
        • Fontana G.P.
        • Jilaihawi H.
        • Kapadia S.
        • Pichard A.D.
        • Douglas P.S.
        • et al.
        Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.
        N Engl J Med. 2012; 366: 1696-1704
        • Zaman S.
        • Gooley R.
        • McCormick L.
        • Harper R.
        • Meredith I.T.
        Pre - transcatheter aortic valve implantation workup in the cardiac catheterisation laboratory.
        Heart Lung Circ. 2015; 24: 1162-1170
        • Kappetein A.
        • Head S.
        • Généreux P.
        • Piazza N.
        • van Mieghem N.
        • Blackstone E.
        • et al.
        Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2).
        Eur J Cardiothorac Surg. 2012; 33: 2403-2418
        • Meredith I.
        • Walters D.
        • Dumonteil N.
        • Worthley S.G.
        • Tchétché D.
        • Manoharan G.
        • et al.
        Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study.
        J Am Coll Cardiol. 2014; 64: 1339-1348
        • Durand E.
        • Blanchard D.
        • Chassaing S.
        • Gilard M.
        • Laskar M.
        • Borz B.
        • et al.
        Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation.
        Am J Cardiol. 2014; 113: 355-360
        • Hioki H.
        • Watanabe Y.
        • Kozuma K.
        • Nara Y.
        • Kawashima H.
        • Kataoka A.
        • et al.
        Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding.
        Heart. 2017; 103: 361-367
        • Mangieri A.
        • Jabbour R.J.
        • Montalto C.
        • Pagnesi M.
        • Regazzoli D.
        • Ancona M.B.
        • et al.
        Single-antiplatelet therapy in patients with contraindication to dual-antiplatelet therapy after transcatheter aortic valve implantation.
        Am J Cardiol. 2017; 119: 1088-1093
        • Ichibori Y.
        • Mizote I.
        • Maeda K.
        • Onishi T.
        • Ohtani T.
        • Yamaguchi O.
        • et al.
        Clinical outcomes and bioprosthetic valve function after transcatheter aortic valve implantation under dual antiplatelet therapy vs aspirin alone.
        Circulation. 2017; 81: 397-404
        • Ussia G.
        • Scarabelli M.
        • Mulè M.
        • Barbanti M.
        • Sarkar K.
        • Cammalleri V.
        • et al.
        Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation.
        Am J Cardiol. 2011; 108: 1772-1776
        • Stabile E.
        • Pucciarelli A.
        • Cota L.
        • Sorropago G.
        • Tesorio T.
        • Salemme L.
        • et al.
        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; 174: 624-627
        • Rodés-Cabau J.
        • Masson J.-B.
        • Welsh R.C.
        • Garcia del Blanco B.
        • Pelletier M.
        • Webb J.G.
        • et al.
        Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon-expandable valve. The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) randomized clinical trial.
        JACC Cardiovasc Interv. 2017; 10: 1357-1365
        • Poliacikova P.
        • Cockburn J.
        • de Belder A.
        • Trivedi U.
        • Hildick-Smith D.
        Antiplatelet and antithrombotic treatment after transcatheter aortic valve implantation — comparison of regimes.
        J Invasive Cardiol. 2013; 25: 544-548
        • Makkar R.R.
        • Fontana G.
        • Jilaihawi H.
        • Chakravarty T.
        • Kofoed K.F.
        • De Backer O.
        • et al.
        Possible subclinical leaflet thrombosis in bioprosthetic aortic valves.
        N Engl J Med. 2015; 373: 2015-2024
        • Chakravarty T.
        • Søndergaard L.
        • Friedman J.
        • De Backer O.
        • Berman D.
        • Kofoed K.F.
        • et al.
        Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study.
        Lancet. 2017; 389: 2383-2392