Ivabradine in Patients with ST-Elevation Myocardial Infarction Complicated by Cardiogenic Shock: A Preliminary Randomized Prospective Study.
OBJECTIVE
An elevated heart rate (HR) is an independent risk factor for mortality and morbidity in patients with acute heart failure (HF). The purpose of this study was to evaluate the impact of ivabradine, a selective HR-lowering agent, in patients with cardiogenic shock (CS) complicating ST-elevation acute myocardial infarction (AMI).


METHODS
Patients with post-AMI CS were randomized to standard treatment (SDT, 28 patients) or to standard treatment plus ivabradine (I + SDT, 30 patients). In the presence of orotracheal intubation (OTI), ivabradine was administered by nasogastric intubation. HR, BP, New York Heart Association (NYHA) class, NT-proBNP, left ventricular ejection fraction (LVEF) and diastolic function (LVDF) were monitored at specific times after the onset of AMI. The primary (surrogate) end-point was the in-hospital halving of plasma NT-proBNP levels. The secondary end-points were cardiovascular death, hospital re-admission for worsening HF, and clinical and haemodynamic improvement.


RESULTS
Treatment groups were statistically similar with regard to age, gender distribution, cardiovascular risk factors, number of diseased vessels and overall treated lesions, AMI site and occurrence of OTI. In-hospital mortality was double in the SDT group in comparison with the I + SDT group (14.3 vs. 6.7 %), but the difference was not statistically significant. HR, BP, NT-proBNP and LVEF favorably changed in both groups, but the change was more relevant in the I + SDT group. LVDF significantly changed only in the I + SDT group (p < 0.01). Patients in the I + SDT group did not experience adverse effects.


CONCLUSIONS
Ivabradine in CS complicating AMI is safe, is associated with a short-term favourable outcome and can be effectively administered by nasogastric intubation.
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy. francesco.barilla@uniroma1.it.|Cardiac Intensive Care Unit "B", Dipartimento Cuore e Grossi Vasi "Attilio Reale", Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. francesco.barilla@uniroma1.it.
Francesco
F
Barillà
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Giuseppe
G
Pannarale
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Concetta
C
Torromeo
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Vincenzo
V
Paravati
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Maria Cristina
MC
Acconcia
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Gaetano
G
Tanzilli
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Enrico
E
Mangieri
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Tania
T
Dominici
Department of Pediatrics and Child Neuropsychiatry, Sapienza University of Rome, Rome, Italy.
Francesco
F
Martino
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Gaetano
G
Pannitteri
Department of Cardiovascular, Respiratory, Nephrologic, Anaesthesiologic and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Carlo
C
Gaudio
D000208:Acute Disease; D000328:Adult; D000368:Aged; D001552:Benzazepines / Q000627:therapeutic use*; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000188:drug therapy; D006801:Humans; D000077550:Ivabradine; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D011446:Prospective Studies; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000188:drug therapy*; D012770:Shock, Cardiogenic / Q000150:complications*; D016277:Ventricular Function, Left / Q000187:drug effects
D001552:Benzazepines; D002317:Cardiovascular Agents; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D000077550:Ivabradine