{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T06:56:44Z","timestamp":1784357804943,"version":"3.55.0"},"reference-count":19,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T00:00:00Z","timestamp":1715558400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cardiovasc. Med."],"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction &amp;gt;35% and a CHA<jats:sub>2<\/jats:sub>DS<jats:sub>2<\/jats:sub>-VASc score \u22654 (men) or \u22655 (women).<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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)\u2009=\u20095.9, <jats:italic>P<\/jats:italic>\u2009&amp;lt;\u20090.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR\u2009=\u20090.84, 95%-CI: 0.65\u20131.10; <jats:italic>P<\/jats:italic>\u2009=\u20090.21). 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>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.\n<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>[<jats:ext-link>https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02341534<\/jats:ext-link>], NCT02341534.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fcvm.2024.1300074","type":"journal-article","created":{"date-parts":[[2024,5,14]],"date-time":"2024-05-14T16:47:47Z","timestamp":1715705267000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":6,"title":["Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial"],"prefix":"10.3389","volume":"11","author":[{"given":"Christian","family":"J\u00f8ns","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Poul Erik","family":"Bloch 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