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.
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.
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.
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.
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.
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)