NOAC in "real world" patients with atrial fibrillation in Italy: results from the ISPAF-2 (Indagine Sicoa Paziente Con Fibrillazione Atriale) survey study

Abstract

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.

Keywords: Anticoagulation; Atrial fibrillation; Guidelines; New oral anticoagulants; Survey; Thrombo-embolic risk.