Carlo Mario Lombardi1, João Pedro Ferreira2, Valentina Carubelli3, Stefan D Anker4, John G Cleland5, Kenneth Dickstein6,7, Gerasimos Filippatos8, Chim C Lang9, Leong L Ng10, Piotr Ponikowski11,12, Nilesh J Samani13, Dirk J van Veldhuisen14, Faiez Zannad2, Adriaan Voors14, Marco Metra3. 1. Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, Cardio-Thoracic Department, University of Brescia, Civil Hospitals, Brescia, Italy. lombardi.carlo@alice.it. 2. French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, Nancy, France. 3. Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, Cardio-Thoracic Department, University of Brescia, Civil Hospitals, Brescia, Italy. 4. Department of Innovative Clinical Trials, University Medical Centre Göttingen (UMG), Robert-Koch-Straße, 37075, Göttingen, Germany. 5. Robertson Centre for Biostatistics and Glasgow Clinical Trials Unit, Glasgow, UK. 6. University of Bergen, Bergen, Norway. 7. Stavanger University Hospital, Stavanger, Norway. 8. Heart Failure Unit, Department of Cardiology, School of Medicine, National and Kopodistrian University of Athens, Athens University Hospital Attikon, Rimini 1, 12462, Athens, Greece. 9. Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK. 10. Department of Cardiovascular Sciences, University of Leicester, and NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, UK. 11. Department of Heart Diseases, Wroclaw Medical University, Borowska 213, 50-556, Wroclaw, Poland. 12. Centre for Heart Diseases, University Hospital, Borowska 213, 50-556, Wroclaw, Poland. 13. Department of Cardiovascular Sciences, University of Leicester, BHF Cardiovascular Research Centre, Glenfield Hospital, Groby Rd, Leicester, LE3 9QP, UK. 14. Department of Cardiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
BACKGROUND: 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. METHODS: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. RESULTS: 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). CONCLUSION: 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.
Authors: Ana García Sarasola; Miguel Alberto Rizzi; Aitor Alquezar Arbé; Sergio Herrera Mateo; Víctor Gil; Pere Llorens; Javier Jacob; Francisco Javier Martín-Sánchez; Pablo Herrero Puente; Rosa Escoda; Begoña Espinosa; Àlex Roset; Raquel Torres-Gárate; José Torres-Murillo; Ana B Mecina; María Pilar López-Díez; José María Álvarez Pérez; Josep Tost; Eva Salvo; María Luisa López-Grima; Cristina Gil; María Mir; Frank Rutzinska; Ovidiu Chioncel; Òscar Miró Journal: Clin Res Cardiol Date: 2020-09-21 Impact factor: 5.460
Authors: Carolyn S P Lam; João Pedro Ferreira; Egon Pfarr; David Sim; Hiroyuki Tsutsui; Stefan D Anker; Javed Butler; Gerasimos Filippatos; Stuart J Pocock; Naveed Sattar; Subodh Verma; Martina Brueckmann; Janet Schnee; Daniel Cotton; Faiez Zannad; Milton Packer Journal: Eur Heart J Date: 2021-11-14 Impact factor: 29.983