Òscar Miró1, Víctor Gil2, Christian Müller3, Alexander Mebazaa4, Héctor Bueno5, Francisco Javier Martín-Sánchez6, Pablo Herrero7, Javier Jacob8, Pere Llorens9. 1. Emergency Department, Hospital Clínic, Barcelona; "Emergencies: processes and pathologies" Research Group, IDIBAPS, Villarroel 170, 08036, Barcelona, Catalonia, Spain. 2. Emergency Department, Hospital Clínic, Barcelona; "Emergencies: processes and pathologies" Research Group, IDIBAPS, Villarroel 170, 08036, Barcelona, Catalonia, Spain. vgilespinosa@gmail.com. 3. Cardiology Department, Basel University, Basel, Switzerland. 4. Department of Anesthesiology and Intensive Care, Lariboisière University Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, Paris, France. 5. Hospital General Universitario Gregorio Marañón and Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain. 6. Emergency Department, Hospital Clínico San Carlos, Madrid, Spain. 7. Emergency Department, Hospital Universitario Central de Asturias, Oviedo, Spain. 8. Emergency Department, Hospital universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. 9. Emergency Department, Home Hospitalization and Short Stay Unit, Hospital General de Alicante, Alicante, Spain.
Abstract
OBJECTIVE: To test how accurate the recently published RELAX-AHF trial was in recruiting real-world patients with acute-decompensated heart failure (ADHF). METHODS AND RESULTS: We compared clinical and outcome data of patients receiving serelaxin in the RELAX-AHF trial (RELAX group, n = 581) with patients included in the EAHFE registry [5497 ADHF from 29 Spanish emergency departments (EDs)]. The EAHFE registry was split into two groups: EAHFE-non-RELAX (patients not fulfilling the RELAX-AHF inclusion criteria; n = 3205, 58.3 %) and EAHFE-RELAX A (patients fulfilling RELAX-AHF inclusion criteria; n = 2292, 41.7 %). The latter group was further refined by also applying exclusion criteria (EAHFE-RELAX B; n = 964, 17.4 %). Both EAHFE-RELAX groups differed from the EAHFE-non-RELAX group in multiple aspects, with the lower the proportion of patients with implantable cardiac defibrillator and with pulmonary diseases the greater the differences found. The RELAX group, compared with the EAHFE-RELAX groups, significantly included fewer females, younger patients, less in NYHA class I/II, less with implantable cardiac defibrillator and on beta-blocker treatment, and patients had lower systolic blood pressure and cardiac and respiratory rates at ED arrival. The EAHFE-RELAX groups had a significantly lower all-cause mortality than EAHFE-non-RELAX group, and qualitative analysis suggested that EAHFE-RELAX groups had a higher mortality than the RELAX group. CONCLUSION: Patients included in the RELAX-AHF trial showed unanticipated differences when compared with a population from the EAHFE registry fulfilling very similar inclusion and exclusion criteria.
RCT Entities:
OBJECTIVE: To test how accurate the recently published RELAX-AHF trial was in recruiting real-world patients with acute-decompensated heart failure (ADHF). METHODS AND RESULTS: We compared clinical and outcome data of patients receiving serelaxin in the RELAX-AHF trial (RELAX group, n = 581) with patients included in the EAHFE registry [5497 ADHF from 29 Spanish emergency departments (EDs)]. The EAHFE registry was split into two groups: EAHFE-non-RELAX (patients not fulfilling the RELAX-AHF inclusion criteria; n = 3205, 58.3 %) and EAHFE-RELAX A (patients fulfilling RELAX-AHF inclusion criteria; n = 2292, 41.7 %). The latter group was further refined by also applying exclusion criteria (EAHFE-RELAX B; n = 964, 17.4 %). Both EAHFE-RELAX groups differed from the EAHFE-non-RELAX group in multiple aspects, with the lower the proportion of patients with implantable cardiac defibrillator and with pulmonary diseases the greater the differences found. The RELAX group, compared with the EAHFE-RELAX groups, significantly included fewer females, younger patients, less in NYHA class I/II, less with implantable cardiac defibrillator and on beta-blocker treatment, and patients had lower systolic blood pressure and cardiac and respiratory rates at ED arrival. The EAHFE-RELAX groups had a significantly lower all-cause mortality than EAHFE-non-RELAX group, and qualitative analysis suggested that EAHFE-RELAX groups had a higher mortality than the RELAX group. CONCLUSION:Patients included in the RELAX-AHF trial showed unanticipated differences when compared with a population from the EAHFE registry fulfilling very similar inclusion and exclusion criteria.
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