NOAC in “real world” patients with atrial fibrillation in Italy: results from the ISPAF-2 (Indagine Sicoa Paziente Con Fibrillazione Atriale) survey study
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In the past few years, new oral anticoagulants (NOACs) targeting directly a single activated clotting factor, have been developed for the treatment of non-valvular atrial fibrillation (AF), which are currently recommended as first-line therapy in AF. The aim of this study is to provide an overall picture on the extent to which oral anticoagulation (OAC) with NOACs correspond to actually prescribed OAC therapy in an unselected, real world, population of consecutive patients with AF in Italy. Compliance with the therapy and quality of life were also assessed. A 50 cardiology unit network located in different geographic areas of Italy enrolled a total of 1742 consecutive outpatients with AF (54.6% males, 45.4% females, mean age 72.5 years). NOACs were prescribed in 56.1% patients and VKA in 43.9% (P < 0.0001). NOACs were significantly more prescribed than VKA in patients with high thrombo-embolic risk score (i.e., CHA2DS2-VASc > 2) (78.2 vs 67.3%, P < 0.0001), but also patients at low risk (i.e., CHA2DS2-VASc < 1 and HAS-BLED < 3) were still under OAC therapy with either NOACs (27%) or VKA (73%). Adherence to therapy (Morisky test) was greater in patients taking NOACs as was the quality of life. The ISPAF-2 study shows that in an Italian population of real-world patients with AF the prescription of OAC according to current guidelines and stroke-risk scoring system is rather high although it still needs to be improved. Contrary to recommendations, in a high proportion of low-risk patients, anticoagulation therapy, with either NOACs and VKA is still prescribed, and this exposes patients to unjustified risks.
KeywordsAtrial fibrillation Anticoagulation New oral anticoagulants Survey Thrombo-embolic risk Guidelines
List of SICOA (Società Italiana CardiologiaOspedalità Accreditata) Investigators: Caiazza Francesco, Casa di Cura Trusso, Ottaviano, Campania; Fazio Giovanni, Casa di Cura Triolo Zancla, Palermo, Sicilia; Esposito Nicolino, Fondazione Evangelica Villa Betania, Napoli, Campania; Guarini Pasquale, Ospedale Villa dei Fiori-Acerra, Napoli, Campania; Lai Ornella; Azienda Ospedaliera Universitaria di Cagliari, Sardegna; Margonato Alberto Ospadale San Raffaele, Milano, Lombardia; Marullo Luciano, casa di Cura Pineta Grande, Castel Volturno, Campania; Mascioli Giosuè, Humanitas Gavazzeni, Bergamo, Lombardia; Morace Nicola Antonio, Istituti Fisioterapici Ospitalieri, Roma, Lazio; Mori Francesca, Centro Cardio toracico Istituto Clinico San Ambrogio, Milano, Lombardia; Proto Alessandro, Ospedali Civili, Brescia, Lombaria; Severino Salvatore, Casa di Cura San Michele, Maddaloni Caserta, Campania; Sposato Barbara, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana, Roma, Lazio; Storti Cesare, Casa di Cura Città di Pavia, Pavia, Lombardia; Vizzardi Enrico, Università degli Studi di Brescia, Brescia, Lombardia.
Compliance with ethical standards
Conflict of interest
Statement of human and animal rights
The procedure followed were in accordance with the ethical standards on human experimentation and with the Helsinki Declaration of 1975.
All patients gave written informed consent.
- 1.Volterrani M, Iellamo F, Rosano G, Guarini P, Pusineri E, Bonassis S et al (2013) Anticoagulation in “real World” patients with atrial fibrillation in Italy; results from the ISPAF (Indagine SICOA Paziente con Fibrillazione Atriale) survey study. Int J Cardiol 168:2733–4729Google Scholar
- 2.Di Pasquale G, Mathieu G, Maggioni AP, Fabbri G, Lucci D, Vescovo G, Pirelli S, Chiarella F, Scherillo M, Gulizia MM, Gussoni G, Colombo F, Panuccio D, Nozzoli C, Berisso MZ, ATA-AF Investigators (2013) Current presentation and management of 7148 patients with atrial fibrillation in cardiology and internal medicine hospital centers: the ATA AF study. Int J Cardiol 167:2895–2903CrossRefPubMedGoogle Scholar
- 4.Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM, ROCKETAF Investigators (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:883–891CrossRefPubMedGoogle Scholar
- 8.Camm AJ, Lip GY, De Caterina R, Salieva I, Atar D, Hohnlose SH et al (2012) 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 33:2719–2747CrossRefPubMedGoogle Scholar
- 11.Gazzetta Ufficiale della Repubblica Italiana. Serie Generale n. 76 del 31.03.2008Google Scholar
- 15.Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Bartels DB, Lip GY, GLORIA-AF Investigators (2017) The changing landscape for stroke prevention in AF: findings from the GLORIA-AF registry phase 2. J Am Coll Cardiol 69:777–785CrossRefPubMedGoogle Scholar
- 20.Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, Kuhls S, van Eickels M, Turpie AG, XANTUS Investigators (2016) XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J 37:1145–1153CrossRefPubMedGoogle Scholar
- 27.Prisco D, Ageno W, Becattini C, On behalf of SIMI (Italian Society of Internal Medicine), FADOI (Federation of Associations of Hospital Doctors on Internal Medicine) and SISET (Italian Society for the Study of Haemostasis and Thrombosis et al (2017) Italian intersociety consensus on DOAC use in internal medicine. Intern Emerg Med 12:387–406CrossRefPubMedGoogle Scholar