Abstract
Geographical differences may impact the treatment of heart failure (HF) and the results of clinical trials. We have investigated the differences between geographical areas across Europe in the BIOSTAT-CHF program. Patients with worsening HF enrolled in BIOSTAT-CHF were subdivided, according to the European geographical areas, into those from Northern countries (The Netherlands, Norway, Sweden, UK), Central countries (Germany, Poland, Serbia, Slovenia), and Mediterranean countries (France, Greece, Italy). Patients were compared for baseline characteristics, treatment, and outcomes. The primary endpoint was a composite of all-cause mortality or HF hospitalization. Among 2516 patients enrolled in BIOSTAT-CHF, 814 (32.3%) were from Northern European centers, 816 (32.4%) from Central European centers, and 886 (35.2%) from Mediterranean centers. Patients from Northern European centers were older, had more severe signs and symptoms of HF, and with lower incidence of non-cardiac comorbidities such as chronic kidney dysfunction, diabetes and, hypertension, compared to those from the Central and Mediterranean centers. Patients receiving ≥ 50% of the target dose of both ACE-I/ARB after the up-titration phase were higher in the Northern European centers compared with the other regions (60% versus 58.7% in the Central European centers and 46.5% in the Mediterranean ones; p < 0.001). The primary endpoint occurred at a higher rate in the Northern centers (44.3% versus 37.4% in central centers and 39.6% in Mediterranean centers; p = 0.014), this difference became non-significant after the adjustment for important confounders. Importantly, treatment up-titration reduced the event rates regardless of the geographical region (p for interaction > 0.05). The BIOSTAT-CHF study showed significant differences in the clinical features, treatment and prognosis in European patients with HF. Patients from the Mediterranean centers less often had the HF treatments up-titrated; however, the treatment up-titration benefited patients irrespective of their geographical region and should be part of the "default" clinical practice.
Highlights
We have investigated differences between geographi cal areas across Europe i n the BIOSTAT-CHF program
Patients with worsening heart failure (HF) enrolled in BIOSTAT-CHF were subdivided, accordi ng to the European geographi cal areas, i nto those from Northern countri es (NC, Netherl ands, Norway, Sweden, Uni ted Ki ngdom), Central countri es (CC, Germany, Pol and, Serbi a, Sl oveni a), and Medi terranean countri es (MC, France, Greece, Ital y)
Several differences in patientsprofile and treatment were identified across Europe in BIOSTAT-CHF and they accounted for di fferences i n outcomes
Summary
Heart failure (HF) has a worldwide diffusion and its prevalence is increasing due to the agi ng of the popul ation and the effi cacy of treatment of acute cardi ovascul ar di seases . 1,2,3,4 Geographi cal di fferences may have an impact on clinical characteristi cs and treatment of the pati ents wi th HF and i nfluence the results of clinical tri al s.5,6,7,8,9 These di fferences may be i mportant even wi thi n one si ngl e conti nent, such i s the case of European countri es. 10,11,12,13 Thi s was fi rst shown i n retrospective analyses of randomized trials and i n regi stri es .14,15,16 The European Soci ety of Cardi ol ogy (ESC) HF Pi l ot Survey showed di fferences across European geographi cal areas. Pati ents from Eastern European countries were younger, with a more frequent i schemi c eti ol ogy and had hi gher systolic blood pressure. 1,2,3,4 Geographi cal di fferences may have an impact on clinical characteristi cs and treatment of the pati ents wi th HF and i nfluence the results of clinical tri al s.5,6,7,8,9. These di fferences may be i mportant even wi thi n one si ngl e conti nent, such i s the case of European countri es. The ai m of thi s secondary, nonprespeci fied, analysis is to i nvestigate the geographic differences in the cl i ni calcharacteri sti cs, prognosi s, and treatment between the pati ents enrol l ed from di fferent geographi cal areas i n BI O STAT-CHF
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