학술논문
Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial
Document Type
article
Author
Christian Jøns; Poul Erik Bloch Thomsen; Sam Riahi; Tom Smilde; Ulrich Bach; Peter Karl Jacobsen; Miloš Táborský; Jozsef Faluközy; Marcus Wiemer; Per Dahl Christensen; Attila Kónyi; Dan Schelfaut; Alan Bulava; Marcin Grabowski; Béla Merkely; Dieter Nuyens; Rajiv Mahajan; Patrick Nagel; Roland Tilz; Jerzy Malczynski; Clemens Steinwender; Johannes Brachmann; Harvey Serota; Jürgen Schrader; Steffen Behrens; Peter Søgaard
Source
Frontiers in Cardiovascular Medicine, Vol 11 (2024)
Subject
Language
English
ISSN
2297-055X
Abstract
ObjectivesCardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome.DesignBIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment.SettingTertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians.ParticipantsPatients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women).InterventionsPatients 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 measuresMACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes.Results790 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