Karl Georg Haeusler1, Paulus Kirchhof2, Claudia Kunze3, Serdar Tütüncü3, Cornelia Fiessler4, Carolin Malsch4, Manuel C Olma5, Muhammad Jawad-Ul-Qamar6, Michael Krämer3, Rolf Wachter7, Dominik Michalski8, Andrea Kraft9, Timolaos Rizos10, Klaus Gröschel11, Götz Thomalla12, Darius G Nabavi13, Joachim Röther14, Ulrich Laufs15, Roland Veltkamp16, Peter U Heuschmann17, Matthias Endres18. 1. Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Berlin, Germany; Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany; German Atrial Fibrillation Network (AFNET), Münster, Germany. 2. German Atrial Fibrillation Network (AFNET), Münster, Germany; Institute of Cardiovascular Sciences, College of Medical and Dental Sciences, Medical School, University of Birmingham, Birmingham, UK; Department of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Department of Cardiology, Sandwell and West Birmingham NHS Trust, Birmingham, UK; University Heart and Vascular Center Hamburg, Hamburg, Germany. 3. Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Berlin, Germany. 4. Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany. 5. Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Berlin, Germany; Klinik und Hochschulambulanz für Neurologie mit Abteilung für Experimentelle Neurologie, Charité, Universitätsmedizin Berlin, Berlin, Germany. 6. Institute of Cardiovascular Sciences, College of Medical and Dental Sciences, Medical School, University of Birmingham, Birmingham, UK; Department of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Department of Cardiology, Sandwell and West Birmingham NHS Trust, Birmingham, UK. 7. Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany; Klinik für Kardiologie und Pneumologie, Universitätsmedizin Göttingen, Germany; German Centre of Cardiovascular Research, Göttingen, Germany. 8. Department of Neurology, University of Leipzig, Leipzig, Germany. 9. Klinik für Neurologie, Krankenhaus Martha-Maria Halle, Halle, Germany. 10. Department of Neurology, Heidelberg University, Heidelberg, Germany. 11. Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. 12. Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 13. Department of Neurology, Vivantes Klinikum Neukölln, Berlin, Germany. 14. Department of Neurology, Asklepios Klinik Altona, Hamburg, Germany. 15. Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany. 16. Department of Neurology, Alfried Krupp Krankenhaus, Essen, Germany; Department of Brain Sciences, Imperial College London, London UK. 17. Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany; Comprehensive Heart Failure Center, University Hospital Würzburg, Würzburg, Germany; Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany. 18. Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Berlin, Germany; Klinik und Hochschulambulanz für Neurologie mit Abteilung für Experimentelle Neurologie, Charité, Universitätsmedizin Berlin, Berlin, Germany; German Center for Neurodegenerative Diseases (DZNE), Berlin, Germany; German Center for Cardiovascular Research (DZHK), Berlin, Germany; Excellence Cluster NeuroCure, Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany. Electronic address: matthias.endres@charite.de.
Abstract
BACKGROUND:Systematic electrocardiogram (ECG) monitoring improves detection of covert atrial fibrillation in stroke survivors but the effect on secondary prevention is unknown. We aimed to assess the effect of systematic ECG monitoring of patients in hospital on the rate of oral anticoagulant use after 12 months. METHODS: In this investigator-initiated, randomised, open-label, parallel-group multicentre study with masked endpoint adjudication, we recruited patients aged at least 18 years with acute ischaemic stroke or transient ischaemic attack without known atrial fibrillation in 38 certified stroke units in Germany. Patients were randomly assigned (1:1) to usual diagnostic procedures for atrial fibrillation detection (control group) or additional Holter-ECG recording for up to 7 days in hospital (intervention group). Patients were stratified by centre using a random permuted block design. The primary outcome was the proportion of patients on oral anticoagulants at 12 months after the index event in the intention-to-treat population. Secondary outcomes included the number of patients with newly diagnosed atrial fibrillation in hospital and the composite of recurrent stroke, major bleeding, myocardial infarction, or death after 6 months, 12 months, and 24 months. This trial was registered with ClinicalTrials.gov, NCT02204267, and is completed and closed for participants. FINDINGS: Between Dec 9, 2014, and Sept 11, 2017, 3465 patients were randomly assigned, 1735 (50·1%) to the intervention group and 1730 (49·9%) to the control group. Oral anticoagulation status was available in 2920 (84·3%) patients at 12 months (1484 [50·8%] in the intervention group and 1436 [49·2%] in the control group). For the primary outcome, at 12 months, 203 (13·7%) of 1484 patients in the intervention group versus 169 (11·8%) of 1436 in the control group were on oral anticoagulants (odds ratio [OR] 1·2 [95% CI 0·9-1·5]; p=0·13). Atrial fibrillation was newly detected in patients in hospital in 97 (5·8%) of 1714 in the intervention group versus 68 (4·0%) of 1717 in the control group (hazard ratio [HR] 1·4 [95% CI 1·0-2·0]; p=0·024). The composite of cardiovascular outcomes and death did not differ between patients randomly assigned to the intervention group versus the control group at 24 months (232 [13·5%] of 1714 vs 249 [14·5%] of 1717; HR 0·9 [0·8-1·1]; p=0·43). Skin reactions due to study ECG electrodes were reported in 56 (3·3%) patients in the intervention group. All-cause death occured in 73 (4·3%) patients in the intervention group and in 103 (6·0%) patients in the control group (OR 0·7 [0·5-0·9]). INTERPRETATION: Systematic core centrally reviewed ECG monitoring is feasible and increases the detection rate of atrial fibrillation in unselected patients hospitalised with acute ischaemic stroke or transient ischaemic attack, if added to usual diagnostic care in certified German stroke units. However, we found no effect of systematic ECG monitoring on the rate of oral anticoagulant use after 12 months and further efforts are needed to improve secondary stroke prevention. FUNDING: Bayer Vital. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.
RCT Entities:
BACKGROUND: Systematic electrocardiogram (ECG) monitoring improves detection of covert atrial fibrillation in stroke survivors but the effect on secondary prevention is unknown. We aimed to assess the effect of systematic ECG monitoring of patients in hospital on the rate of oral anticoagulant use after 12 months. METHODS: In this investigator-initiated, randomised, open-label, parallel-group multicentre study with masked endpoint adjudication, we recruited patients aged at least 18 years with acute ischaemic stroke or transient ischaemic attack without known atrial fibrillation in 38 certified stroke units in Germany. Patients were randomly assigned (1:1) to usual diagnostic procedures for atrial fibrillation detection (control group) or additional Holter-ECG recording for up to 7 days in hospital (intervention group). Patients were stratified by centre using a random permuted block design. The primary outcome was the proportion of patients on oral anticoagulants at 12 months after the index event in the intention-to-treat population. Secondary outcomes included the number of patients with newly diagnosed atrial fibrillation in hospital and the composite of recurrent stroke, major bleeding, myocardial infarction, or death after 6 months, 12 months, and 24 months. This trial was registered with ClinicalTrials.gov, NCT02204267, and is completed and closed for participants. FINDINGS: Between Dec 9, 2014, and Sept 11, 2017, 3465 patients were randomly assigned, 1735 (50·1%) to the intervention group and 1730 (49·9%) to the control group. Oral anticoagulation status was available in 2920 (84·3%) patients at 12 months (1484 [50·8%] in the intervention group and 1436 [49·2%] in the control group). For the primary outcome, at 12 months, 203 (13·7%) of 1484 patients in the intervention group versus 169 (11·8%) of 1436 in the control group were on oral anticoagulants (odds ratio [OR] 1·2 [95% CI 0·9-1·5]; p=0·13). Atrial fibrillation was newly detected in patients in hospital in 97 (5·8%) of 1714 in the intervention group versus 68 (4·0%) of 1717 in the control group (hazard ratio [HR] 1·4 [95% CI 1·0-2·0]; p=0·024). The composite of cardiovascular outcomes and death did not differ between patients randomly assigned to the intervention group versus the control group at 24 months (232 [13·5%] of 1714 vs 249 [14·5%] of 1717; HR 0·9 [0·8-1·1]; p=0·43). Skin reactions due to study ECG electrodes were reported in 56 (3·3%) patients in the intervention group. All-cause death occured in 73 (4·3%) patients in the intervention group and in 103 (6·0%) patients in the control group (OR 0·7 [0·5-0·9]). INTERPRETATION: Systematic core centrally reviewed ECG monitoring is feasible and increases the detection rate of atrial fibrillation in unselected patients hospitalised with acute ischaemic stroke or transient ischaemic attack, if added to usual diagnostic care in certified German stroke units. However, we found no effect of systematic ECG monitoring on the rate of oral anticoagulant use after 12 months and further efforts are needed to improve secondary stroke prevention. FUNDING: Bayer Vital. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.
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