Early intra-aortic balloon pump in acute decompensated heart failure complicated by cardiogenic shock: Rationale and design of the randomized Altshock-2 trial
| Autor: | Maurizio Bottiroli, Jonica Campolo, Nuccia Morici, Alice Sacco, Sergio Leonardi, Manlio Cipriani, Serafina Valente, Gianfranco Frigerio, Luisa Cacciavillani, Fabrizio Oliva, Matteo Rota, Federico Pappalardo, Elena Corrada, Maria Frigerio, Gaetano M. De Ferrari, Guido Tavazzi, Daniele Grosseto, Claudia Marini |
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| Rok vydání: | 2021 |
| Předmět: |
Inotrope
medicine.medical_specialty Time Factors Acute decompensated heart failure medicine.medical_treatment Shock Cardiogenic 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Clinical endpoint Humans Medicine Prospective Studies 030212 general & internal medicine Myocardial infarction Renal replacement therapy Intra-aortic balloon pump Heart Failure Intra-Aortic Balloon Pumping business.industry Cardiogenic shock Cardiovascular Agents medicine.disease Renal Replacement Therapy Sample Size Acute Disease Cardiology Heart-Assist Devices Cardiology and Cardiovascular Medicine business |
| Zdroj: | American Heart Journal. 233:39-47 |
| ISSN: | 0002-8703 |
| DOI: | 10.1016/j.ahj.2020.11.017 |
| Popis: | Background Cardiogenic shock (CS) is a systemic disorder associated with dismal short-term prognosis. Given its time-dependent nature, mechanical circulatory support may improve survival. Intra-aortic balloon pump (IABP) had gained widespread use because of the easiness to implant and the low rate of complications; however, a randomized trial failed to demonstrate benefit on mortality in the setting of acute myocardial infarction. Acute decompensated heart failure with cardiogenic shock (ADHF-CS) represents a growing resource-intensive scenario with scant data and indications on the best management. However, a few data suggest a potential benefit of IABP in this setting. We present the design of a study aimed at addressing this research gap. Methods and design The Altshock-2 trial is a prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients with ADHF-CS will be randomized to early IABP implantation or to vasoactive treatments. The primary end point will be 60 days patients’ survival or successful bridge to heart replacement therapy. The key secondary end point will be 60-day overall survival; 60-day need for renal replacement therapy; in-hospital maximum inotropic score, maximum duration of inotropic/vasopressor therapy, and maximum sequential organ failure assessment score. Safety end points will be in-hospital occurrence of bleeding events (Bleeding Academic Research Consortium >3), vascular access complications and systemic (noncerebral) embolism. The sample size for the study is 200 patients. Implications The Altshock-2 trial will provide evidence on whether IABP should be implanted early in ADHF-CS patients to improve their clinical outcomes. |
| Databáze: | OpenAIRE |
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