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May 2, 2015European Heart JournalOpen Access

The trial was prematurely terminated for futility, with 63 primary events among 1357 patients in the intervention arm and 61 events among 1361 patients in the control arm (HR 1.06, P = 0.73).

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Why the study?

Does a strategy of remote monitoring for subclinical atrial fibrillation coupled with a risk-based algorithm for oral anticoagulant initiation and maintenance reduce stroke, systemic embolism, and major bleeding in patients with implanted defibrillators?

Population

2718 patients with implanted defibrillator and cardiac resynchronization devices, without contraindications…

Comparison

Continuous home monitoring of defibrillators for… vs Control arm.

Design

Editorial, Prospective randomized trial.

Follow-up

median of 2 years

Authors

JHJeff S. HealeyRLRenato D. LópesSCStuart J. Connolly

Discussion

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Overview

Remote monitoring-guided OAC shows no benefit in ICD patients; leaves open whether refined algorithms warrant further study.

Structured PICO

Does a strategy of remote monitoring for subclinical atrial fibrillation coupled with a risk-based algorithm for oral anticoagulant initiation and maintenance reduce stroke, systemic embolism, and major bleeding in patients with implanted defibrillators?

P
Population
2718 patients with implanted defibrillator and cardiac resynchronization devices, without contraindications to oral anticoagulants.
I
Intervention
Continuous home monitoring of defibrillators for detection of subclinical atrial fibrillation coupled with a risk-based algorithm for oral anticoagulant initiation and maintenance based on CHADS2 score, AF burden, and time since last AF episode.
C
Comparator
Control arm (standard care, with approximately 60% oral anticoagulant use in control group patients who developed AF).
O
Outcome
Composite of stroke, systemic embolism, and major bleeding.composite

A strategy of remote monitoring for subclinical atrial fibrillation to guide oral anticoagulant therapy in ICD patients did not reduce the composite risk of stroke, systemic embolism, and major bleeding.

Limitations

  • Use of a composite primary outcome which included both stroke and major bleeding, which offset each other.
  • Complex intervention dependent on several individual components based on unproven assumptions.
  • High use of oral anticoagulants (60%) in control group patients with AF.
  • Oral anticoagulant withdrawal strategy challenged by the lack of a temporal relationship between subclinical AF and stroke.

Cite This Study

Healey et al. (2015) studied this question.

synapsesocial.com/papers/6a7ad2f6fb5b6b43000e2156https://doi.org/10.1093/eurheartj/ehv159
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Implantable cardiac monitors in cryptogenic stoke: Clarity or added uncertainty?2022
  2. 2Screening for Atrial Fibrillation in Relation to Stroke and Mortality Risk2021 · 13 citations
  3. 3Emerging Management Challenges Posed by Atrial Fibrillation Detected After Stroke2023 · 3 citations
  4. 4Optimizing the treatment of atrial fibrillation: contributions by remote monitoring2008 · 6 citations
  5. 5Subclinical atrial fibrillation in need of more assertive evidence2017 · 17 citations