First clinical trial comparing implantable defibrillator + drug vs. drug alone

A clinical trial comparing the effectiveness of implantable cardioverter-defibrillator (ICD) implants versus medications in myocardial infarction survivors with heart failure has enrolled the first patient.

Interest in this clinical trial is focused on the fact that it has been unclear which patients would benefit from ICD implantation and whether ICD implantation is superior to drug therapy in terms of long-term cost-effectiveness.

On the 21st local time, the European Society of Cardiology (ESC) announced that PROFID EHRA, the first patient registration project to prevent sudden death after heart attack, has begun.

Sudden cardiac death mostly occurs in survivors of myocardial infarction, and is considered a major public health problem, accounting for approximately 1 in 5 deaths in Europe.

The PROFID EHRA clinical trial was designed to determine whether ICD implantation is actually effective in patients whose hearts do not beat properly after a heart attack, with the goal of preventing sudden cardiac death after myocardial infarction.

As drug treatment becomes more sophisticated, drug treatment alone lowers the risk of sudden death in patients and reduces the need for ICDs, so we will look at the long-term cost-benefit of drug treatment versus ICD implantation.

This study determines the non-inferiority of drug treatment alone compared to drug treatment and ICD combination therapy in patients with myocardial infarction who have symptoms of heart failure and reduced left ventricular ejection fraction (less than 35%).

Participants will be randomly assigned to optimal medical therapy alone or medical therapy plus ICD implantation and then followed for approximately 2.5 years for the primary outcome of all-cause mortality.

Researchers will also examine the impact of the two treatment strategies on death from cardiovascular causes, sudden cardiac death, hospital readmissions from cardiovascular causes, length of stay, quality of life, and cost-effectiveness. The study is scheduled to last approximately 49 months and results are expected to be available in early 2027.

Professor Gerhard Hindricks, Principal Investigator of the trial, said: “PROFID EHRA is groundbreaking research that could change the way we prevent sudden cardiac death in the clinical setting. “There are many, and conversely, some patients who could benefit are missing out,” he pointed out.

He explained the background, saying, “Through this clinical trial, we will provide new evidence on which patients should receive an ICD, which patients should be hospitalized, and procedures to avoid complications or unintended shock from the device.”

Approximately 3,595 patients will be recruited in the clinical trial from 180 hospitals in 13 countries, including Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Israel, Poland, Spain, Sweden, the Netherlands, and the United Kingdom. The first patient was enrolled at the German Heart Center (Segeberger Kliniken).

“The PROFID EHRA trial is a very important scientific study that will redefine the use of ICDs in myocardial infarction survivors,” said Professor Jose L. Merino, coordinator of the PROFID EHRA trial. “It is reflected in clinical practice around the world,” he added.