纳入随机对照Find-AF 2试验的急性缺血性卒中患者的基线特征。

Baseline characteristics of patients with acute ischaemic stroke included in the randomised controlled Find-AF 2 trial.

作者信息

Wasser Katrin, Uhe Tobias, Schäbitz Wolf-Rüdiger, Köhrmann Martin, Dichgans Martin, Brachmann Johannes, Laufs Ulrich, Gelbrich Götz, Petroff David, Prettin Christiane, Michalski Dominik, Pelz Johann, Kraft Andrea, Etgen Thorleif, Soda Hassan, Bethke Florian, Schellinger Peter D, Althaus Katharina, Hamann Gerhard F, Grond Martin, Kallmünzer Bernd, Petersen Martina, Pallesen Lars-Peder, Ertl Michael, Zickler Philipp, Poli Sven, Haeusler Karl Georg, Steiner Thorsten, Sparenberg Paul, Kermer Pawel, Kopczak Anna, Kellert Lars, Nückel Martin, Liman Jan, Ringleb Peter Arthur, Mende Meinhard, Wagner Marcus, Bochert Deborah, Schnieder Marlena, Amanzada Imke, Gröschel Sonja, Hahn Marianne, Uphaus Timo, Gröschel Klaus, Wachter Rolf

机构信息

Department of Neurology, University of Göttingen Medical Centre, Göttingen, Germany.

Department of Cardiology, University of Leipzig Medical Center, Liebigstraße 20, Haus 4, 04103, Leipzig, Germany.

出版信息

Neurol Res Pract. 2025 Jun 26;7(1):45. doi: 10.1186/s42466-025-00399-8.

DOI:10.1186/s42466-025-00399-8

PMID:40571918

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12203715/

Abstract

BACKGROUND

In the Find-AF 2 randomised controlled trial, we investigate whether a risk-adapted intensified heart rhythm monitoring with subsequent initiation of oral anticoagulation in ischaemic stroke patients leads to a reduction of recurrent ischaemic stroke and systemic embolism. The objective of this analysis is to present baseline characteristics of the overall Find-AF 2 study population and stratified by low or high risk for developing AF.

METHODS

The Find-AF 2 trial included acute ischaemic stroke patients ≥ 60 years of age within 30 days of ischaemic stroke of any cause. Before randomisation, patients received a 24-h Holter-ECG to exclude those with easily detectable AF and to determine the presence or absence of enhanced supraventricular ectopic activity (ESVEA), used as a marker indicating high or low risk for developing AF. Those without AF were randomly assigned 1:1 to either usual care diagnostics for AF detection (control group) or enhanced, prolonged and intensified ECG monitoring (intervention group). In the intervention group, patients with ESVEA received an implantable cardiac monitor (ICM), whereas those without ESVEA received repeated annual 7-day Holter ECGs. We present baseline characteristics of the overall Find-AF 2 population and stratified by ESVEA.

RESULTS

Between July 2020 and July 2024, 5227 patients (mean age 72.3 ± 7.5 years, 40% female, 2618 intervention group, 2609 control group) were randomised from 52 study centres in Germany within a median of 5 (IQR 3-7) days after the index stroke. The most frequent stroke aetiologies were cryptogenic (60%) and small vessel occlusion (19%). 1152 (22%) patients were at high risk for developing AF and 4075 (78%) at low risk. Patients within the high-risk stratum were significantly older (mean age 75.2 versus 71.5 years, p < 0.001), more often had moderate to severe stroke (34% versus 30%, p < 0.001), non-lacunar (70% versus 64%, p < 0.001) and of cryptogenic aetiology (64% vs 58%, p < 0.001).

CONCLUSIONS

The Find-AF 2 trial has successfully completed recruitment of a large acute ischaemic stroke population with different stroke subtypes. The follow-up is ongoing and results are expected within two years.

TRIAL REGISTRATION

ClinicalTrials.gov, Identifier NCT04371055, registered 24 April 2020.

摘要

背景

在“寻找房颤2”随机对照试验中，我们研究了对缺血性卒中患者进行风险适应性强化心律监测并随后启动口服抗凝治疗是否能降低复发性缺血性卒中和全身性栓塞的发生率。本分析的目的是呈现“寻找房颤2”研究总体人群的基线特征，并按发生房颤的低风险或高风险进行分层。

方法

“寻找房颤2”试验纳入了在任何原因导致的缺血性卒中30天内年龄≥60岁的急性缺血性卒中患者。在随机分组前，患者接受24小时动态心电图检查，以排除那些易于检测到房颤的患者，并确定是否存在增强的室上性异位活动（ESVEA），ESVEA用作指示发生房颤高风险或低风险的标志物。无房颤的患者按1:1随机分配至常规房颤检测诊断组（对照组）或强化、延长和加强的心电图监测组（干预组）。在干预组中，有ESVEA的患者接受植入式心脏监测器（ICM），而无ESVEA的患者每年接受7天的重复动态心电图检查。我们呈现了“寻找房颤2”总体人群的基线特征，并按ESVEA进行分层。

结果

2020年7月至2024年7月期间，来自德国52个研究中心的5227例患者（平均年龄72.3±7.5岁，40%为女性，2618例在干预组，2609例在对照组）在首次卒中后的中位时间5（IQR 3 - 7）天内被随机分组。最常见的卒中病因是隐源性（60%）和小血管闭塞（19%）。1152例（22%）患者发生房颤的风险高，4075例（78%）风险低。高风险分层的患者年龄显著更大（平均年龄75.2岁对71.5岁，p<0.001），中度至重度卒中更常见（34%对30%，p<0.001），非腔隙性（70%对64%，p<0.001）且病因不明（64%对58%，p<0.001）。