Frontiers in cardiovascular medicine · 2024
Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial.
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Jøns Christian, Bloch Thomsen Poul Erik, Riahi Sam, Smilde Tom, Bach Ulrich, Jacobsen Peter Karl, Táborský Miloš, Faluközy Jozsef, Wiemer Marcus, Christensen Per Dahl, Kónyi Attila, Schelfaut Dan, Bulava Alan, Grabowski Marcin, Merkely Béla, Nuyens Dieter, Mahajan Rajiv, Nagel Patrick, Tilz Roland, Malczynski Jerzy, Steinwender Clemens, Brachmann Johannes, Serota Harvey, Schrader Jürgen, Behrens Steffen, Søgaard Peter
Аннотация
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.
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.