ICM-guided management did not improve MACE after MI

The BIO|GUARD-MI trial failed to meet its primary endpoint when no significant difference in major adverse cardiac events (MACE) emerged over 2.5 years in patients with myocardial infarction (MI) randomised to insertable cardiac monitor (ICM)-guided management or to standard care. Subanalyses did find a significant benefit for those at high risk.

Presented by Prof. Christian Jøns (Rigshospitalet, Denmark), the findings and exploratory analyses of BIO|GUARD-MI (NCT02341534) which enrolled 802 patients, of whom 790 were randomised—average age of 72 years and 27% % women—randomised to either receive an ICM or standard of care [1]. Additional therapy for arrhythmias (i.e. oral anticoagulants, pacemakers, or β-blockers), including atrial fibrillation in 46.0% and bradycardia in 39.0%, was added to management in 39.0% of the ICM group and in 6.7% of the group without ICM.

The results showed no differences in MACE outcomes in the ICM group compared with those in the standard-care group (HR 0.84; 95% CI 0.64–1.10; P=0.21). However, subanalyses did reveal that the MACE risk for ICM patients was significantly reduced for those at high risk (HR 0.57; 95% CI 0.38–0.86) but not for those at low risk (HR 1.11; 95% CI 0.79–1.59). Additionally, although subanalyses of patients with a history of ST-elevation MI (STEMI) did not reveal any differences (HR 1.10; 95% CI 0.72–1.69; P=0.66), in the subgroup with previous non-STEMI, patients with ICM had better MACE outcomes (HR 0.69; 95% CI 0.49–0.98; P=0.035); although there was only a trend for interaction (P=0.09).

The investigators concluded that continuous ICM monitoring can reveal asymptomatic but clinically important arrhythmias that can guide treatment decisions, perhaps improving clinical outcomes, in patients with previous non-STEMI but may not play a relevant role for other patients.

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   1. Jøns C, et al. The Clinical Effect Of Arrhythmia Monitoring After Myocardial Infarction. Abstract 410–14, ACC 2022, 2–4 April, Washington DC, USA.

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Posted on 15 June 202224 June 2022