纳入随机对照find - af2试验的急性缺血性卒中患者的基线特征

Q2 Medicine
Katrin Wasser, Tobias Uhe, Wolf-Rüdiger Schäbitz, Martin Köhrmann, Martin Dichgans, Johannes Brachmann, Ulrich Laufs, Götz Gelbrich, David Petroff, Christiane Prettin, Dominik Michalski, Johann Pelz, Andrea Kraft, Thorleif Etgen, Hassan Soda, Florian Bethke, Peter D Schellinger, Katharina Althaus, Gerhard F Hamann, Martin Grond, Bernd Kallmünzer, Martina Petersen, Lars-Peder Pallesen, Michael Ertl, Philipp Zickler, Sven Poli, Karl Georg Haeusler, Thorsten Steiner, Paul Sparenberg, Pawel Kermer, Anna Kopczak, Lars Kellert, Martin Nückel, Jan Liman, Peter Arthur Ringleb, Meinhard Mende, Marcus Wagner, Deborah Bochert, Marlena Schnieder, Imke Amanzada, Sonja Gröschel, Marianne Hahn, Timo Uphaus, Klaus Gröschel, Rolf Wachter
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引用次数: 0

摘要

背景:在find - af2随机对照试验中,我们研究了在缺血性卒中患者开始口服抗凝治疗后加强心律监测是否能减少复发性缺血性卒中和全身性栓塞。本分析的目的是呈现总体发现-房颤2研究人群的基线特征,并按发生房颤的低或高风险进行分层。方法:发现-房颤2试验纳入了年龄≥60岁的急性缺血性卒中患者,这些患者在任何原因的缺血性卒中发生后30天内。在随机化之前,患者接受24小时动态心电图检查,以排除那些容易检测到房颤的患者,并确定是否存在增强的室上异位活动(ESVEA),这是发生房颤的高风险或低风险的标志。没有房颤的患者被随机按1:1分配到房颤检测的常规诊断组(对照组)或增强、延长和强化的心电图监测组(干预组)。在干预组中,有ESVEA的患者接受植入式心脏监护仪(ICM),而没有ESVEA的患者接受每年重复的7天动态心电图。我们提出了总体find - af2人群的基线特征,并通过ESVEA进行了分层。结果:在2020年7月至2024年7月期间,5227例患者(平均年龄72.3±7.5岁,女性占40%,干预组2618例,对照组2609例)在指数卒中后中位5 (IQR 3-7)天内从德国的52个研究中心随机抽取。最常见的中风病因是隐源性(60%)和小血管闭塞(19%)。1152例(22%)患者发生房颤的风险高,4075例(78%)患者发生房颤的风险低。高危人群中的患者明显更老(平均年龄75.2岁vs 71.5岁)。结论:find - af2试验成功招募了大量不同脑卒中亚型的急性缺血性脑卒中人群。后续工作正在进行中,预计将在两年内取得结果。试验注册:ClinicalTrials.gov,标识符NCT04371055,注册于2020年4月24日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Baseline characteristics of patients with acute ischaemic stroke included in the randomised controlled Find-AF 2 trial.

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.

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