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Randomized Controlled Trial
. 2025 Jan 21;14(2):e034512.
doi: 10.1161/JAHA.123.034512. Epub 2025 Jan 10.

Excessive Supraventricular Ectopic Activity in Patients With Acute Ischemic Stroke Is Associated With Atrial Fibrillation Detection Within 24 Months After Stroke: A Predefined Analysis of the MonDAFIS Study

Affiliations
Randomized Controlled Trial

Excessive Supraventricular Ectopic Activity in Patients With Acute Ischemic Stroke Is Associated With Atrial Fibrillation Detection Within 24 Months After Stroke: A Predefined Analysis of the MonDAFIS Study

Karl Georg Haeusler et al. J Am Heart Assoc. .

Abstract

Background: Excessive supraventricular ectopic activity (ESVEA) is regarded as a risk marker for later atrial fibrillation (AF) detection.

Methods and results: The investigator-initiated, prospective, open, multicenter MonDAFIS (Impact of Standardized Monitoring for Detection of Atrial Fibrillation in Ischemic Stroke) study randomized 3465 patients with acute ischemic stroke without known AF 1:1 to usual diagnostic procedures for AF detection or additive Holter monitoring in hospital for up to 7 days, analyzed in a core laboratory. Secondary study objectives include the comparison of recurrent stroke, myocardial infarction, major bleeding, and all-cause death within 24 months in patients with ESVEA (defined as ectopic supraventricular beats ≥480/day or atrial runs of 10-29 seconds or both) versus patients with newly diagnosed AF versus patients without ESVEA or AF (non-ESVEA/AF), randomized to the intervention group. Overall, 1435 (84.8%) of 1714 patients randomized to the intervention group had analyzable study ECG monitoring of at least 48 hours' duration within the first 72 hours of monitoring. ESVEA was detected in 363 (25.3%) patients, while AF was first detected in 48 (3.3%) patients. Within 24 months, AF was newly detected in 67 (18.5%) patients with ESVEA versus 60 (5.9%) patients without ESVEA/AF- (P<0.001). The composite outcome at 24 months was not different between patients with ESVEA and patients without ESVEA/AF (15.2% versus 12.6%; P=0.242). All-cause death was numerically higher in patients with ESVEA (6.6% versus 3.2%), but failed statistical significance (P=0.433) in multivariate analysis (including age, heart failure, stroke severity, and creatinine at baseline).

Conclusions: ESVEA in the acute phase of ischemic stroke or transient ischemic attack is associated with AF detection during follow-up and therefore may be used to select patients for prolonged ECG monitoring.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02204267.

Keywords: ECG; atrial fibrillation; atrial run; death; stroke; supraventricular ectopy.

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Conflict of interest statement

Dr Haeusler reports speaker's honoraria, consulting fees, lecture honoraria, and/or study grants from Abbott, Alexion, Amarin, AstraZeneca, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol‐Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Portola, Premier Research, Sanofi, SUN Pharma, and W. L. Gore and Associates. Dr Royl received speaker's honoraria and/or reimbursement for congress traveling and accommodation from Boehringer‐Ingelheim, Bristol‐Myers Squibb, AstraZeneca, Ipsen, Boston Scientific, Novartis, and Daiichi Sankyo. Dr Petzold receives research support from the DZNE, the Fondation Leducq (Transatlantic Network of Excellence 23CVD03), and the DFG under Germany's Excellence Strategy—EXC2151–390873048, and reports no relevant fees outside the submitted work. Dr Thomalla has received speaker's honoraria or consulting fees from Acandis, Bayer Healthcare, Boehringer Ingelheim, Covidien, Bristol‐Myers‐Squibb, Portola, Stryker, and Pfizer. Dr Nabavi has received speaker's honoraria and consulting fees from Bayer, Boehringer Ingelheim, Bristol‐Myers‐Squibb, Daiichi Sankyo, Novartis, and Pfizer. Dr Röther has received speaker's honoraria and consulting fees from Bayer, Boehringer Ingelheim, Bristol‐Myers‐Squibb, Pfizer, and Astra Zeneca. Dr Laufs reports honoraria/reimbursements for lectures, participation in studies, scientific cooperations (with Leipzig University), consulting, travel, support (of colleagues) or support of scientific meetings (within the past 5 years) by Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, DFG, MSD, Pfizer, and Sanofi. Dr Veltkamp has received speaker's honoraria, consulting fees, and research support from Bayer, Boehringer Ingelheim, Bristol‐Myers‐Squibb, Daiichi Sankyo, Apoplex Medical Technologies, Novartis, and Pfizer. Dr Veltkamp is an investigator of Imperial BRC and partially funded by the European Union's Horizon 2020 research and innovation program under grant agreement No. 754517 (PRESTIGE‐AF). Dr Heuschmann reports grants from Charité–Universitätsmedizin Berlin during study conduct (within MonDAFIS for biometry; member scientific board); research grants from German Ministry of Research and Education, German Research Foundation, European Union, Charité–Universitätsmedizin Berlin, German Parkinson Society, University Hospital Würzburg, Robert Koch Institute, German Heart Foundation, Federal Joint Committee (G‐BA) within the Innovationfond, Bavarian State, German Research Foundation, German Cancer Aid, University Hospital Heidelberg (within RASUNOA‐prime; supported by an unrestricted research grant to the University Hospital Heidelberg from Bayer, BMS, Boehringer Ingelheim, Daiichi Sankyo), University Göttingen (within FIND‐AF randomized; supported by an unrestricted research grant to the University Göttingen from Boehringer Ingelheim), outside the submitted work. Dr Kirchhof receives research support for basic, translational, and clinical research projects from the European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), and German Centre for Cardiovascular Research, and from several drug and device companies active in atrial fibrillation, and has received honoraria from several such companies in the past. Dr Kirchhof is listed as inventor on 2 patents held by the University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). Dr Endres received funding from DFG under Germany's Excellence Strategy—EXC‐2049—390 688 087, Collaborative Research Center ReTune TRR 295–424 778 381, Clinical Research Group KFO 5023 BeCAUSE‐Y, BMBF, DZNE, DZHK, DZPG, EU, Corona Foundation, and Fondation Leducq. Dr Endres reports grants from Bayer and fees paid to the Charité from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol‐Myers‐Squibb, Daiichi Sankyo, Sanofi, and Pfizer. All other authors report no conflict of interests outside the submitted work.

Figures

Figure 1
Figure 1. Study design and prevalence of predefined clinical end points within 24 months after the index stroke according to the presence or absence of excessive supraventricular ectopic activity in the absence of AF.
AF indicates atrial fibrillation; MonDAFIS, Impact of Standardized Monitoring for Detection of Atrial Fibrillation in Ischemic Stroke; NIHSS, National Institutes of Health Stroke Scale; and TIA, transient ischemic attack.
Figure 2
Figure 2. Prevalence of predefined clinical end points during follow‐up.
Risk of recurrent stroke, myocardial infarction, major bleeding, or all‐cause death (A) or all‐cause death (B) within 24 months after the index stroke according to the presence of atrial fibrillation in‐hospital (red), the presence of (blue) or absence (green) of ESVEA in the absence of AF within 72 hours of study ECG monitoring in hospital. P values are from univariate log‐rank tests. AF indicates atrial fibrillation; and ESVEA, excessive supraventricular ectopic activity.

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