The PROFID EHRA trial is receiving growing attention within the cardiology community. In a recent article published in Sensible Medicine, Dr. John Mandrola referred to it as “the most important trial of the decade in cardiology.” This large-scale, European study challenges a long-standing clinical standard: the routine use of implantable cardioverter defibrillators (ICDs) in patients with reduced left ventricular ejection fraction (LVEF ≤35%) following myocardial infarction.
Current international guidelines recommend ICD implantation in this patient population for the primary prevention of sudden cardiac death, based on landmark trials conducted over two decades ago. However, the landscape of cardiovascular care has changed significantly. Advances in heart failure therapy, secondary prevention strategies, and revascularization techniques have improved outcomes and reduced the incidence of arrhythmic death. PROFID EHRA aims to determine whether ICDs remain necessary in this evolving context.
The trial is enrolling more than 3,500 patients across 13 countries. Participants are randomized to receive either guideline-directed medical therapy alone or in combination with an ICD. The primary endpoint is all-cause mortality, with secondary endpoints including cardiovascular mortality, sudden cardiac death, hospitalization rates, and quality of life.
While the trial’s scientific value is widely recognized, its execution presents challenges. As Dr. Mandrola notes, many clinicians find it difficult to randomize patients to a no-ICD arm due to established clinical habits, financial disincentives, and the strength of existing guidelines. Despite these obstacles, the PROFID EHRA consortium remains committed to generating robust, contemporary evidence to inform clinical decision-making.
The outcomes of PROFID EHRA have the potential to reshape clinical practice by identifying patients who can safely avoid ICD implantation, thereby reducing unnecessary interventions and improving cost-effectiveness in cardiovascular care.
🔗 Read Dr. Mandrola’s full commentary: PROFID EHRA: The Most Important Trial of the Decade in Cardiology