Biomonitoring in Patients with Preserved Left Ventricular Function after Diagnosed Myocardial Infarction
Jøns C et al, ACC 2022
First Outcome Trial on the Benefits of ICMs in Post-MI Patients
The BIO|GUARD-MI study is the first trial to investigate the impact of continuous arrhythmia monitoring with an implantable cardiac monitor (ICM) on clinical outcomes in post-myocardial infarction (MI) patients. Implantable cardiac monitors are also referred to as implantable loop recorders.
The study demonstrated that early treatment of high-risk, non-ST-segment elevation myocardial infarction (NSTEMI) patients guided by continuous arrhythmia monitoring with implantable loop recorders reduces major adverse cardiac events (MACE) by 31%.
67% of patients with an implantable loop recorder had a first arrhythmia detected after two years, leading to guideline-recommended change in treatment in 39.4%. Only 6.7% of post-MI patients without an implantable loop recorder received a change in treatment.
Read more about the study design, key results, and clinical relevance below.
As presented at a Late-Breaking Clinical Trial session at the American College of Cardiology’s 71st Annual Scientific Session in Washington D.C. on April 4, 2022
- Randomized, controlled, parallel-group, open, prospective, multi-center, international study
- To investigate whether the early diagnosis of cardiac arrhythmias, provided by the BIOMONITOR with Home Monitoring, and the consequent treatment of the patient will decrease the risk to experience a major adverse cardiovascular event (MACE) in patients after MI, with LVEF >35% and CHA2DS2-VASc score ≥4 (men) or ≥5 (women)
- 790 patients
Key Result 1
In the primary endpoint analysis of the total patient population, a trend towards MACE reduction in the implantable cardiac monitor (ICM) group was observed but did not reach statistical significance (HR=0.84, p=0.21).
A sub-group analysis shows a 31% reduction of MACE in patients with non-ST segment elevation myocardial infarction (NSTEMI).
Primary endpoint: Time to first MACE in NSTEMI and STEMI
MACE reduction with ICM in NSTEMI patients
Key Result 2
The benefit of ICM-guided treatment in NSTEMI patients appears to be connected to their higher risk for primary endpoint events.
Risk for primary endpoint in NSTEMI and STEMI
increased risk of MACE in NSTEMI patients
Key Result 3
Continuous arrhythmia monitoring in post-MI patients identifies a large arrhythmia burden, and many of the arrhythmias require guideline recommended therapies.
Detection of arrhythmias and treatment
- Arrhythmias are connected to poor outcomes after myocardial infarction.
- BIO|GUARD-MI is the first trial to investigate the impact of continuous arrhythmia monitoring with ICMs on clinical outcomes in post-MI patients.
- Early treatment of high-risk NSTEMI patients guided by continuous arrhythmia monitoring with BIOMONITOR and Home Monitoring may reduce major adverse cardiac events (MACE).
|Main inclusion Criteria
|Main Exclusion Criteria