PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment.
UNASSIGNED: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.
UNASSIGNED: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment.
UNASSIGNED: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.
摘要：
■心律失常可预测心肌梗死（MI）后的不良预后。我们研究了使用可插入心脏监护仪（ICM）进行心律失常监测是否可以改善治疗和预后。
■BIO|GUARD-MI是一个随机的，具有盲化结果评估的国际开放标签研究。
■三级护理机构监测心律失常，而随访仍由初级保健医生进行。
■ST段抬高（STEMI）或非ST段抬高MI后，射血分数>35％且CHA2DS2-VASc评分≥4（男性）或≥5（女性）的患者。
■除了标准的MI后治疗外，患者被随机分配接受或不接受ICM。设备检测到的心律失常通过远程监测触发了立即指南推荐的治疗变化。
■MACE，定义为心血管死亡或因心血管原因导致的急性计划外住院的复合。
■790名患者（平均年龄71岁，72%男性，计划中的1,400名患者中有51％非STEMI）入组，并随访中位数为31.6个月。在2年,39.4%的装置组和6.7%的对照组对心律失常进行了治疗[风险比(HR)=5.9,P<0.0001]。最常见的心律失常是心房颤动，停顿和心动过缓。使用ICM并没有改善整个队列的结局（HR=0.84，95％-CI：0.65-1.10；P=0.21）。在次要分析中，梗死类型之间的统计学显著交互作用表明,预先指定的非STEMI亚组获益.危险因素分析表明，这可能与非STEMI患者MACE发生率较高有关。
■无症状但可操作的心律失常在梗死后患者中的负担很大。然而,在整个队列中,使用ICM监测心律失常并没有改善结局.事后分析表明，它可能对非STEMI患者或其他高危亚组有益。
■[https://www.clinicaltrials.gov/ct2/show/NCT02341534]，NCT02341534。
■BIO|GUARD-MI是一个随机的，具有盲化结果评估的国际开放标签研究。
■三级护理机构监测心律失常，而随访仍由初级保健医生进行。
■ST段抬高（STEMI）或非ST段抬高MI后，射血分数>35％且CHA2DS2-VASc评分≥4（男性）或≥5（女性）的患者。
■除了标准的MI后治疗外，患者被随机分配接受或不接受ICM。设备检测到的心律失常通过远程监测触发了立即指南推荐的治疗变化。
■MACE，定义为心血管死亡或因心血管原因导致的急性计划外住院的复合。
■790名患者（平均年龄71岁，72%男性，计划中的1,400名患者中有51％非STEMI）入组，并随访中位数为31.6个月。在2年,39.4%的装置组和6.7%的对照组对心律失常进行了治疗[风险比(HR)=5.9,P<0.0001]。最常见的心律失常是心房颤动，停顿和心动过缓。使用ICM并没有改善整个队列的结局（HR=0.84，95％-CI：0.65-1.10；P=0.21）。在次要分析中，梗死类型之间的统计学显著交互作用表明,预先指定的非STEMI亚组获益.危险因素分析表明，这可能与非STEMI患者MACE发生率较高有关。
■无症状但可操作的心律失常在梗死后患者中的负担很大。然而,在整个队列中,使用ICM监测心律失常并没有改善结局.事后分析表明，它可能对非STEMI患者或其他高危亚组有益。
■[https://www.clinicaltrials.gov/ct2/show/NCT02341534]，NCT02341534。
