SINGLE-AFHot Line 1Atrial FibrillationNew England Journal of Medicine
Direct Oral Anticoagulation for Atrial Fibrillation with Intermediate Stroke Risk
Anticoagulation for Atrial Fibrillation with Intermediate Stroke Risk
Presenting authorBoyoung JoungElectrophysiology · Yonsei University, Seoul, Republic of KoreaBoyoung Joung is Professor of Internal Medicine in the Cardiology Division at Yonsei University College of Medicine and Vice President of Yonsei University Severance Hospital in Seoul, South Korea. He is Director of the Yonsei Heart Rhythm Center and principal investigator of the Korean multicenter AF registry (CODE-AF). He has chaired the Korean atrial fibrillation guidelines (2018 and 2021) and NOAC guidelines.
Overview
Supports DOAC use in intermediate-risk AF; extends randomized evidence beyond high-risk populations.
Key result
DOAC therapy reduced the risk of stroke, systemic embolism, major bleeding, or cardiovascular death compared to no anticoagulation (0.5% vs 1.5%; HR 0.31; 95% CI 0.10-0.94; P=0.03).
Discussion
SINGLE-AF has reported — post the first read.
Key Points
- DOAC therapy reduced composite cardiovascular events to 0.5% versus 1.5% without anticoagulation (hazard ratio, 0.31), with stroke occurring in 0.3% versus 1.1% of patients.
- Multicenter, open-label superiority trial randomized 1803 patients with intermediate-risk atrial fibrillation to receive either DOAC therapy or no anticoagulation over 24 months.
- Direct oral anticoagulation significantly lowers ischemic risk without increasing major bleeding or serious adverse events in patients with intermediate stroke risk.
Study Design
Type
RCT (n=1,803)
Blinding
Open-label, adjudicator-masked
Multicenter
Yes
Structured PICO
Does DOAC therapy reduce the composite risk of stroke, systemic embolism, major bleeding, or cardiovascular death compared to no anticoagulation in patients with atrial fibrillation at intermediate risk for stroke?
P
Population
1,803 patients (mean age 60.4 years, 23.7% women) with atrial fibrillation and intermediate stroke risk, followed for 24 months.
I
Intervention
Direct oral anticoagulant (DOAC) therapy
C
Comparator
No anticoagulant therapy
O
Outcome
Composite of stroke, systemic embolism, major bleeding, or death from cardiovascular causes at 24 monthscomposite
In patients with atrial fibrillation at intermediate stroke risk, DOAC therapy significantly reduced the composite risk of stroke, systemic embolism, major bleeding, or cardiovascular death compared to no anticoagulation.
Main Result
Hazard Ratio: 0.31 (95% CI 0.1–0.94)
Absolute Event Rate: 0.5% vs 1.5%
Absolute Risk Reduction: 1%
p-value: p=0.03