Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial)

for the RAFAS Investigators

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BACKGROUND: The purpose of the RAFAS (Risk and Benefits of Urgent Rhythm Control of Atrial Fibrillation in Patients With Acute Stroke) trial was to explore the risks and benefits of early rhythm control in patients with newly documented atrial fibrillation (AF) during an acute ischemic stroke (IS). METHOD AND RESULTS: An open-label, randomized, multicenter trial design was used. If AF was diagnosed, the patients in the early rhythm control group started rhythm control within 2 months after the occurrence of an IS, unlikely the usual care. The primary end points were recurrent IS within 3 and 12 months. The secondary end points were a composite of all deaths, unplanned hospitalizations from any cause, and adverse arrhythmia events. Patients (n=300) with AF and an acute IS (63.0% men, aged 69.6±8.5 years; 51.2% with paroxysmal AF) were randomized 2:1 to early rhythm control (n=194) or usual care (n=106). A total of 273 patients excluding those lost to follow-up (n=27) were analyzed. The IS recurrences did not differ between the groups within 3 months of the index stroke (2 [1.1%] versus 4 [4.2%]; hazard ratio [HR], 0.257 [log-rank P=0.091]) but were significantly lower in the early rhythm control group at 12 months (3 [1.7%] versus 6 [6.3%]; HR, 0.251 [log-rank P=0.034]). Although the rates of overall mortality, any cause of hospitalizations (25 [14.0%] versus 16 [16.8%]; HR, 0.808 [log-rank P=0.504]), and arrhythmia-related adverse events (5 [2.8%] versus 1 [1.1%]; HR, 2.565 [log-rank P=0.372]) did not differ, the proportion of sustained AF was lower in the early rhythm control group than the usual care group (60 [34.1%] versus 59 [62.8%], P<0.001) in 12 months. CONCLUSIONS: The early rhythm control strategy of an acute IS decreased the sustained AF and recurrent IS within 12 months without an increase in the composite adverse outcomes.

Original languageEnglish
Article numbere023391
JournalJournal of the American Heart Association
Issue number3
Publication statusPublished - 2022 Feb 1

Bibliographical note

Funding Information:
This work was supported by grants HI19C0114 and HI21C0011 from the Korea Health 21 R&D Project, Ministry of Health and Welfare, and grants NRF-2020R1A2B01001695 and NRF-2017R1E1A1A01078382. In addition, this work was supported by the Korea Medical Device Development Fund grant funded by the Korea government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health & Welfare, the Ministry of Food and Drug Safety) (project number: 9991006899, KMDF_ PR_20200901_0234, NTIS, KMDF-RnD 202014X28-00). The funders had no role in the design or conducting the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the article; and decision to submit the article for publication.

Publisher Copyright:
© 2022 The Authors.

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine


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