TY - JOUR
T1 - Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI)
T2 - a randomized trial
AU - Jøns, Christian
AU - Bloch Thomsen, Poul Erik
AU - Riahi, Sam
AU - Smilde, Tom
AU - Bach, Ulrich
AU - Jacobsen, Peter Karl
AU - Táborský, Miloš
AU - Faluközy, Jozsef
AU - Wiemer, Marcus
AU - Christensen, Per Dahl
AU - Kónyi, Attila
AU - Schelfaut, Dan
AU - Bulava, Alan
AU - Grabowski, Marcin
AU - Merkely, Béla
AU - Nuyens, Dieter
AU - Mahajan, Rajiv
AU - Nagel, Patrick
AU - Tilz, Roland
AU - Malczynski, Jerzy
AU - Steinwender, Clemens
AU - Brachmann, Johannes
AU - Serota, Harvey
AU - Schrader, Jürgen
AU - Behrens, Steffen
AU - Søgaard, Peter
N1 - © 2024 Jøns, Bloch Thomsen, Riahi, Smilde, Bach, Jacobsen, Táborský, Faluközy, Wiemer, Christensen, Kónyi, Schelfaut, Bulava, Grabowski, Merkely, Nuyens, Mahajan, Nagel, Tilz, Malczynski, Steinwender, Brachmann, Serota, Schrader, Behrens and Søgaard.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - cardiac arrhythmia
KW - implantable cardiac monitor
KW - myocardial infarction
KW - randomized controlled trial
KW - telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85194817624&partnerID=8YFLogxK
U2 - 10.3389/fcvm.2024.1300074
DO - 10.3389/fcvm.2024.1300074
M3 - Journal article
C2 - 38807948
SN - 2297-055X
VL - 11
SP - 1300074
JO - Frontiers in Cardiovascular Medicine
JF - Frontiers in Cardiovascular Medicine
M1 - 1300074
ER -