Implementation of personalised risk prediction and prevention of sudden cardiac death after myocardial infarction

Personalised prevention of sudden cardiac death: from analysis of existing data to large trials

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 847999.

Background

Current clinical guidelines

Only a minority of post-MI patients with left ventricular ejection fraction (LVEF) ≤ 35% that currently receive prophylactic implantable cardioverter defibrillator (ICD) will ever need the device – others are only exposed to potentially severe complications due to the implantation.

Patients with LVEF > 35% are not eligible for ICD implantation – in absolute numbers, the majority of deaths due to sudden cardiac death (SCD) occur in exactly this group.

The aim of PROFID

Protection of patients from SCD after myocardial infarction by personalized ICD implantation across the whole range of left ventricular ejection fraction.

Improvement of current insufficient strategy for primary prevention ICD implantation.

Our goal in PROFID

Evaluation of a novel approach with implementation of the prediction model for the whole spectrum of post-MI patients.

Proving the clinical benefit for patients who will be reclassified as high risk and considered eligible for ICD treatment.

Proving that patients reclassified as low risk who will no longer receive an ICD bades on the prediciton model, are not unduly harmed by this personalised approach.

Clinicians will be able to stratify patients using the risk calculation tool developed in this project and a personalised treatment approach for ICD implantation implemented in the clinic.

STRATEGY

Our strategy in PROFID

  1. Development of a clinical prediction model incorporating a variety of parameters that predict the individual risk for SCD.
  2. Turning the clinical prediction model into a web-based risk calculation tool.
  3. Evaluation of a novel approach with implementation of the prediction model in two indepent clinical trials.
  4. Offering the tool via the website of the European Society of Cardiology (ESC) and updating clinical guidelines by ESC.

The PROFID risk calculator

Will be offered as freely available easy-to-use web application via the website of the ESC at the end of the project.

Will consider risk factors such as age, sex, comorbidities, other cardiobascular events or interventions, medications, routine laboratory  values and imaging.

Is developed by analysis ~ 1 million real-world post-MI patient data using traditional statistics and machine learning.

Will allowfor any given patient who has had a myocardial infarction at some point in his life, an estimation of the risk of sudden cardiac death and the risk of death from other causes in the next 12 months.

Will allow to estimate the expected benefit from ICD implantation.

Example of what the PROFID risk calculator tool could look like –
the screenshot is taken from the ESC calculator for the risk of SCD in hypertrophic cardiomyopathy.
PROFID TRIALS

profid-preserved study approach

profid-reduced study approach

Superiority clinical trial with randomised comparison of ICD implantation versus optimal medical treatment in patients with LVEF > 35% that would not receive an ICD according to current guidelines and a high individual risk for SCD as predicted by the clinical prediction model.

(1,440 patients to be enrolled)

Non-inferiority clinical trial with randomised comparison of ICD implantation versus optimal medical treatment in post-MI patients with a LVEF ≤ 35% that would receive an ICD according to current guidelines and a low individual risk for SCD as predicted by the clinical prediction model.

(2,480 patients to be enrolled)

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Further Information

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