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. 2024 May 13:11:1300074.
doi: 10.3389/fcvm.2024.1300074. eCollection 2024.

Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial

Christian Jøns  1 , Poul Erik Bloch Thomsen  2 , Sam Riahi  2 , Tom Smilde  3 , Ulrich Bach  4 , Peter Karl Jacobsen  1 , Miloš Táborský  5 , Jozsef Faluközy  6 , Marcus Wiemer  7 , Per Dahl Christensen  8 , Attila Kónyi  9 , Dan Schelfaut  10 , Alan Bulava  11 , Marcin Grabowski  12 , Béla Merkely  13 , Dieter Nuyens  14 , Rajiv Mahajan  15 , Patrick Nagel  16 , Roland Tilz  17 , Jerzy Malczynski  18 , Clemens Steinwender  19 , Johannes Brachmann  20 , Harvey Serota  21 , Jürgen Schrader  22 , Steffen Behrens  23 , Peter Søgaard  2
Affiliations

Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial

Christian Jøns et al. Front Cardiovasc Med. .

Abstract

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.

Keywords: cardiac arrhythmia; implantable cardiac monitor; myocardial infarction; randomized controlled trial; telemedicine.

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Conflict of interest statement

UB has received lecture fees from Boehringer, Astra Zeneca and Bayer, and travel costs from Boehringer, Astra Zeneca, Bayer, and Bristol Myers Squibb. MG reports consulting and lecture fees from Abbott Medical, Biotronik, Boston Sc. and Medtronic. BM reports grant or contract payments from Medtronic and Boston Scientific and lecture fees from Biotronik and Abbott Medical. RM reports grant or contract payments from Abbott Medical, Medtronic, Bayer and lecture fees from Bayer. RT reports consulting fees from Abbott and Boston Sc. and honoraria for lectures from Abbott Medical, Biotronik and Boston Sc. JS is an employee of Biotronik. SB reports lecture fees and travel costs from Biotronik in the context of this study, and lecture fees from Astra Zeneca, Bayer, Berlin Chemie, Boehringer, Bristol Myers Squibb, and Novartis, and DSMB or advisory board membership fees from Astra Zeneca, Bayer, Berlin Chemie, Boehringer, Bristol Myers Squibb, and Novartis. The authors declare that this study received funding from Biotronik SE & Co. KG. The funder supported study design, data collection, analysis, interpretation of data and the writing of this article.

Figures

Figure 1
Figure 1
Trial profile. GP, general practitioner; ICM, implantable cardiac monitor.
Figure 2
Figure 2
Time to first arrhythmia. Time to first ICM-detected arrhythmia (green line), time to first arrhythmia resulting in a therapy change in the ICM group (blue line), and time to first arrhythmia resulting in a therapy change in the control group (red line). Day 0 is the discharge from index hospitalization. ICM, implantable cardiac monitor.
Figure 3
Figure 3
Freedom from primary endpoint. The probability of freedom from primary endpoint. Day 0 is the discharge from index hospitalization. CI, confidence interval; HR, hazard ratio; ICM, implantable cardiac monitor.
Figure 4
Figure 4
Predefined subgroup analyses of the primary endpoint. Only STEMI/NSTEMI showed significant interaction with the study effect. Subgroups with a study benefit were NSTEMI, male gender and BMI >30. For the definition of CHA2DS2-VASc, see Table 1. CI, confidence interval; HR, hazard ratio; ICM, implantable cardiac monitor group; Int, interaction; LV, left ventricular; NSTEMI, absence of ST-segment elevation; STEMI, presence of ST-segment elevation at the index myocardial infarction.
See this image and copyright information in PMC

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