BIO Guard-MI

BIOguard MI
Biomonitoring in Patients with Preserved Left Ventricular Function after Diagnosed Myocardial Infarction

Study Design

  • 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 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 major adverse cardiac event (MACE) in NSTEMI and STEMI

Image
BIOGUARD-MI key results

↓ 31%

MACE reduction with ICM in NSTEMI patients

 

Image
BIOGUARD-MI key results

Key Result 2

The benefit of ICM-guided treatment in NSTEMI patients appears to be connected to their higher risk for primary endpoint events.

Image
BIOGUARD-MI key results

↑75%

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.

Image
BIOGUARD-MI

Clinical Relevance

  • 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).
     
Study Objective 
  • To investigate whether early treatment after ICM-documented arrhythmias in high-risk post-MI patients improves outcome 
Primary Endpoints
  • Time to first major cardiac adverse event (MACE)
  • MACE is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons
Sample Size
  • 790 patients
Clinical Sites
  • 60 investigational sites in Europe, Australia, and USA
Main inclusion Criteria
  • History of MI according to guidelines
  • CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women
  • LVEF > 35 % 
Main Exclusion Criteria
  • Permanent oral anticoagulation treatment for atrial fibrillation
  • Pacemaker or ICD implanted or indication for implantation
Flowchart
Devices
  • Biomonitor 2 or BIOMONITOR III + Home Monitoring
Follow-Up
  • Patients were followed for a median duration of 2.5 years after randomization
Study Duration
  • August 2015 - April 2020
Reference no.
  • NCT02341534
Steering Committee
  • Dr. Christian Jons (Rigshospitalet, Denmark)
  • Prof. Steffen Behrens (Vivantes Humboldt-Klinikum & Klinikum Spandau, Germany)
  • Professor Peter Sogaard (Aalborg University Hospital, Denmark)
  • Prof. Poul Erik Bloch Thomsen (Denmark)