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Direct oral anticoagulant therapy reduces primary outcomes in patients with atrial fibrillation and intermediate stroke riskBlood Thinners Cut Stroke Risk for Some Heart Rhythm Patients

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Key Takeaway
Consider direct oral anticoagulants to reduce primary endpoints in atrial fibrillation patients with intermediate stroke risk.

The trial investigated the efficacy of direct oral anticoagulant therapy in patients with atrial fibrillation who were identified as having an intermediate risk of stroke. The primary outcome was a composite of stroke, systemic embolism, major bleeding, and death from cardiovascular causes over a period of 24 months. The study compared patients receiving direct oral anticoagulants against those receiving no anticoagulation.

Results showed a lower risk of the primary endpoint in the group receiving direct oral anticoagulants compared to the group receiving no anticoagulation. Additionally, a lower incidence of stroke was observed in the treatment group. Regarding safety, the rates of systemic embolism and major bleeding were reported as similar between the two groups, and serious adverse events were comparable between the treatment and control groups.

The authors noted that the study utilized an open-label design, which may impact the interpretation of the results. While the trial suggests that direct oral anticoagulants may be effective for patients with atrial fibrillation and intermediate stroke risk, the open-label nature of the study means these findings should be integrated into clinical practice with appropriate caution.

Atrial fibrillation is a common heart rhythm problem that can raise the chance of a stroke. Doctors often give blood thinners to people with this condition, but it has been unclear whether those at moderate risk benefit. A new study from South Korea tested a direct oral anticoagulant (DOAC) in patients with atrial fibrillation who were not at high risk.

The study included 1,803 patients. All had a CHADS-VASc score of 1 (men) or 2 (women), which means they had a moderate risk of stroke. Half received a DOAC, and half received no blood thinner. The researchers followed them for 24 months.

The main finding was that the group taking the DOAC had a much lower chance of the combined outcome of stroke, systemic embolism (a clot in the body), major bleeding, or death from heart causes. About 0.5% of people on the DOAC had this combined outcome, compared with 1.5% of those not taking it. That is about a 70% lower chance. The result was statistically significant.

When looking at stroke alone, the DOAC group also did better: 0.3% had a stroke versus 1.1% in the no-treatment group. Systemic embolism and major bleeding were similar in both groups. Serious side effects happened in about 9% of people in both groups. No one died from heart causes in either group.

The study was open-label, meaning patients and doctors knew who was taking the drug. This could affect how results are reported. Also, the number of events was small, so the findings need to be confirmed in larger studies. The research was funded by the Ministry of Health and Welfare, South Korea, and others.

For patients with atrial fibrillation and moderate stroke risk, this study suggests that taking a DOAC may lower the chance of stroke and other serious problems. However, treatment decisions should be made with a doctor, considering each person's situation.

What this means for you:
Blood thinners may lower stroke and related risks for atrial fibrillation patients at moderate risk.

Study Details

Study typeRct
Sample sizen = 1,803
EvidenceLevel 2
Follow-up24.0 mo
PublishedSep 2026
View Original Abstract ↓
BACKGROUND: Current U.S. and European guidelines recommend oral anticoagulation as a class IIa indication in patients with atrial fibrillation at intermediate risk for stroke; however, evidence from randomized trials is needed. METHODS: We conducted a multicenter, open-label, adjudicator-masked superiority trial in South Korea involving patients with atrial fibrillation and an intermediate risk of stroke (a score of 1 in men and 2 in women on the CHADS-VASc scale; range, 0 to 9, with higher scores indicating a greater risk of stroke). Patients were randomly assigned in a 1:1 ratio to receive either direct oral anticoagulant (DOAC) therapy or no anticoagulation. The primary end point was a composite of stroke, systemic embolism, major bleeding, or death from cardiovascular causes at 24 months. RESULTS: Of 1803 patients who underwent randomization, 902 were assigned to receive DOAC therapy and 901 were assigned to receive no anticoagulant therapy. The mean age of the patients was 60.4 years, and 23.7% were women. At 24 months, a primary end-point event had occurred in 4 patients (cumulative incidence, 0.5%) in the DOAC group and in 13 (cumulative incidence, 1.5%) in the no-anticoagulant group (difference, -1.0 percentage points; 95% confidence interval [CI], -2.0 to -0.1; P = 0.03; hazard ratio, 0.31; 95% CI, 0.10 to 0.94). Stroke occurred in 3 patients (cumulative incidence, 0.3%) in the DOAC group and in 10 (cumulative incidence, 1.1%) in the no-anticoagulant group. The incidence of systemic embolism and major bleeding appeared to be similar in the two trial groups, and no deaths from cardiovascular causes occurred in either group. Serious adverse events occurred in 80 patients (8.9%) in the DOAC group and in 84 (9.3%) in the no-anticoagulant group. CONCLUSIONS: Among patients with atrial fibrillation at intermediate risk for stroke, DOAC therapy led to a lower risk of stroke, systemic embolism, major bleeding, or death from cardiovascular causes at 24 months than no anticoagulation. (Funded by the Ministry of Health and Welfare, South Korea, and others; SINGLE-AF ClinicalTrials.gov number, NCT04437654.).
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