Seeking new heights in acute heart failure syndromes: Lessons from ASCEND and EVEREST

摘要

Safely improving signs and symptoms of heart failure is a major goal in the early management of patients with acute heart failure syndromes (AHFS). The use of available pharmacological agents for the acute management of patients hospitalized with heart failure is largely empirical and has not changed substantially for the last two decades. Over the past two decades, the standard for regulatory approvability for AHFS drugs, however, has radically changed-from haemodynamic benefits alone to demonstration of clinical efficacy and longer term safety. Based on available data, none of the currently employed agents would meet today's standards for approval based on evidence for clinical efficacy and safety. Within clinical practice guidelines, there are no therapeutic Class I, level-of-evidence A guideline recommendations for AHFS. Furthermore, the majority of AHFS trials conducted in the last decade has been negative, in terms of efficacy and/or safety. Results from the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) and the Acute Study of Clinical Effectiveness of Nesiritide in Decompen-sated Heart Failure Trial (ASCEND-HF), two of the largest trials conducted to date, provide reason for re-examining our approach to clinical investigation and regulatory decision-making in this condition.