Key result
Early rhythm control in patients with acute ischemic stroke and atrial fibrillation reduced recurrent ischemic stroke at 12 months compared to usual care (1.7% vs 6.3%; HR 0.251; P=0.034).
Why the study?
The study was designed to explore the risks and benefits of early rhythm control in patients with newly documented AF during an acute ischemic stroke.
Does early rhythm control reduce recurrent ischemic stroke in patients with newly documented atrial fibrillation during an acute ischemic stroke?
RCT (n=300)
Open-label
2:1
Yes
Does early rhythm control reduce recurrent ischemic stroke in patients with newly documented atrial fibrillation during an acute ischemic stroke?
Hazard Ratio: 0.251
Absolute Event Rate: 1.7% vs 6.3%
p-value: p=0.034
Early rhythm control in patients with newly documented atrial fibrillation during an acute ischemic stroke significantly reduces recurrent ischemic stroke at 12 months.
Supports early rhythm control to reduce recurrent stroke after acute ischemic stroke with new AF; extends prior trials to this acute high-risk population.
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. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT 02285387.
No takes yet. Share an insight, caveat, or question.
Park et al. (2022) conducted an RCT in Acute ischemic stroke and newly documented atrial fibrillation (n=300). Early rhythm control vs. Usual care was evaluated on Recurrent ischemic stroke within 12 months (HR 0.251, p=0.034). Early rhythm control in patients with acute ischemic stroke and atrial fibrillation reduced recurrent ischemic stroke at 12 months compared to usual care (1.7% vs 6.3%; HR 0.251; P=0.034).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: