PROFID EHRA, the first clinical trial seeking to challenge routine implantation of defibrillators in heart attack survivors with heart failure has just been launched. The European Society of Cardiology is a partner in this large-scale trial.
Implantable Cardioverter Defibrillators (ICDs)
Heart attack survivors are at an increased risk for death, especially sudden cardiac death, due to left ventricular ejection fraction (LVEF) abnormalities. Currently, patients with heart failure have an ICD implanted under their skin.
Within this context, in the late 1990s and early 2000s, two significant randomized trials, MADIT II and SCD-HeFT, showed that primary prophylactic implantation of an ICD in patients with a very reduced LVEF was associated with improved survival.
These observations resulted in international guidelines that recommend routine implantation of an ICD in heart attack survivors with a severely abnormal LVEF for primary prevention of sudden cardiac death.
However, the treatment of these patients has evolved significantly in recent years. New classes of medicinal treatments include mineralocorticoid receptor antagonists, angiotensin receptor-neprilysin inhibitors, and sodium-glucose cotransporter 2 inhibitors, which reduce the risk for sudden death in patients with heart failure, thereby reducing the need for shocks from ICDs.
A New Study
It is therefore possible that the risk-benefit ratio of routine ICD implantation in patients with a severely abnormal LVEF after a heart attack for primary prevention of sudden cardiac death is now different from what it was 20 or so years ago.
Researchers cite a need to reevaluate the potential benefits of and risks for ICD implantation in myocardial infarction survivors presenting with a reduced LVEF on current optimal drug treatment in a randomized and sufficiently powered study like PROFID EHRA.
Gerhard Hindricks, MD, PhD, head trial investigator, said, "PROFID EHRA is a groundbreaking study that could change the prevention of sudden cardiac death in clinical practice. Currently, many patients who receive an ICD never need one, while some who could benefit miss out. This trial will provide novel, randomized evidence on which patients should receive a defibrillator and which patients can be spared an unnecessary procedure that typically requires an overnight stay in the hospital and may lead to complications or unintended shocks from the device."
First Patient Enrolled
The trial will recruit 3595 patients from 180 hospitals in 13 countries: Austria, Belgium, the Czech Republic, Denmark, France, Germany, Hungary, Israel, Poland, Spain, Sweden, the Netherlands, and the United Kingdom. The first patient was enrolled from the Heart Center Segeberger Kliniken in Germany. The project has received funding from the European Union.
Participants are being randomly allocated to optimal medical therapy alone or optimal medical therapy plus ICD implantation. Participants will be followed up for around 2.5 years for the primary outcome of all-cause death. The investigators will also examine the impact of the two treatment strategies on all-cause mortality.
Jose L. Merino, MD, PhD, president of the European Heart Rhythm Association and national coordinator of the PROFID EHRA trial in Spain, said, "The PROFID EHRA trial is set to redefine the use of ICDs in myocardial infarction survivors and is therefore a very important scientific study for the EHRA and for clinical practice globally."
This article was translated from the Medscape French edition.