OBJECTIVES: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome. DESIGN: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment. SETTING: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians. PARTICIPANTS: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women). INTERVENTIONS: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring. MAIN OUTCOME MEASURES: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes. RESULTS: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI. CONCLUSIONS: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups. CLINICAL TRIAL REGISTRATION: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.

1st Department of Cardiology Medical University of Warsaw Warsaw Poland

Biotronik SE and Co KG Berlin Germany

Cardiovascular Centre Onze Lieve Vrouw Clinic Aalst Aalst Belgium

Department of Cardiology Aalborg University Hospital Aalborg Denmark

Department of Cardiology České Budějovice Hospital and Faculty of Health and Social Sciences University of South Bohemia České Budějovice Czech Republic

Department of Cardiology Charité Universitätsmedizin Berlin Berlin Germany

Department of Cardiology Fakultní Nemocnice Olomouc Olomouc Czech Republic

Department of Cardiology Johannes Wesling Universitätsklinik Minden Germany

Department of Cardiology Kepler University Hospital Linz Linz Austria

Department of Cardiology Klinikum Coburg Coburg Germany

Department of Cardiology Lyell McEwin Hospital and Adelaide Medical School The University of Adelaide Adelaide SA Australia

Department of Cardiology Rigshospitalet University of Copenhagen Copenhagen Denmark

Department of Cardiology Scheperziekenhuis Treant Zorggroep Emmen Netherlands

Department of Cardiology St Louis Heart and Vascular Bridgeton MO United States

Department of Cardiology Universitätsklinikum Schleswig Holstein Campus Lübeck Lübeck Germany

Department of Cardiology Viborg Regional Hospital Viborg Denmark

Department of Cardiology Vivantes Humboldt Klinikum and Klinikum Spandau Berlin Germany

Department of Cardiology Vivantes Humboldt Klinikum Berlin Germany

Heart and Vascular Centre Semmelweis University Budapest Hungary

Heart Institute The University of Pécs Pécs Hungary

Herning Hospital Herning Denmark

National Hospital of Cardiology Balatonfüred Hungary

Ziekenhuis Oost Limburg Genk Belgium

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ClinicalTrials.gov
NCT02341534